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A Study to Evaluate Patient Characteristics and Treatment Patterns Among Rheumatoid Arthritis Patients

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04047121
Collaborator
(none)
1,349
Enrollment
1
Location
5.1
Actual Duration (Months)
266.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a retrospective cohort study to evaluate patient characteristics, treatment patterns including a 6-factor effectiveness proxy measure, health care resource use and associated costs among Rheumatoid Arthritis patients initiating treatment comparator groups of interest between January 2014 and September 2016 across three United States insurance claims databases.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1349 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Evaluation of Xeljanz Access Barriers Via Patient OOP Costs and TNFi Cycling
    Actual Study Start Date :
    May 20, 2019
    Actual Primary Completion Date :
    Oct 21, 2019
    Actual Study Completion Date :
    Oct 21, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Truven Health MarketScan

    The Truven Health MarketScan Research Databases reflects the combined healthcare service use of individuals covered by Truven Health clients (including employers, health plans, and hospitals) nationwide.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Who Were Persistent With Index Medication During 12 Months Post-index Date [During 12 months post-index date]

      Persistent with the index medication was defined as not having a gap in the therapy of at least 60 days between prescription fill dates and their administration. Index medications were tofacitinib, adalimumab or etanercept.

    2. Percentage of Participants Who Immediately Switched Index Medication During 12 Months Post-index Date [During 12 months post-index date]

      Participants who switched from index medication immediately were those who initiated a non-index advanced therapy before end of a 60-day gap in index medication. Index medications were tofacitinib, adalimumab or etanercept.

    3. Percentage of Participants Who Discontinued Then Switched Index Medication During 12 Months Post-index Date [During 12 months post-index date]

      Participants who discontinued index medication then switched from index medication were those who had gap in the index medication therapy of at least 60 days and then after the gap they switched to an advanced therapy different from index medication. Index medications were tofacitinib, adalimumab or etanercept.

    4. Percentage of Participants Who Discontinued Then Restarted Index Medication During 12 Months Post-index Date [During 12 months post index date]

      Participants who discontinued index medication and then restarted index medication were those who had a gap in the index medication therapy of at least 60 days and the first advanced therapy observed after the gap was the index medication. Index medications were tofacitinib, adalimumab or etanercept.

    5. Percentage of Participants Who Discontinued Without Switching or Restarting Index Medication During 12 Months Post-index Date [During 12 months post index date]

      Participants who discontinued index medication without switching or restarting index medication were those who had a gap in index medication therapy of at least 60 days and there were no claims for either the index medication or a different advanced therapy for the remainder of the follow-up period. Index medications were tofacitinib, adalimumab or etanercept.

    Secondary Outcome Measures

    1. Percentage of Participants Who Switched Index Medication Any Time During 12 Months Post-index Date [During 12 months post-index date]

      Participants who switched from index medication at any time during the 12-month follow-up post-index period were evaluated. Index medications were tofacitinib, adalimumab or etanercept.

    2. Mean of Number of Days to Immediate Switch From Index Medication During 12 Months Post-index Date [During 12 months post-index date]

      Participants who switched from index medication immediately were those who initiated a non-index advanced therapy before the end of a 60-day gap in index medication. Index medications were tofacitinib, adalimumab or etanercept. Number of days to immediately switch from index medication = immediate switch date - index date + 1.

    3. Mean of Number of Days to Immediate or Delayed Switch Index Medication During 12 Months Post-index Date [During 12 month post-index date]

      Number of days to immediate or delayed switch from index medication any time during the 12-month follow-up period = immediate or delayed switch date - index date + 1. Index medications were tofacitinib, adalimumab or etanercept.

    4. Mean of Number of Days to Discontinue Index Medication During 12 Months Post-index Date [During 12 months post-index date]

      Number of days to discontinue index medication = date of last persistent index medication prescription/administration + days supply- index date + 1. Index medications were tofacitinib, adalimumab or etanercept. Persistent with the index medication was defined as not having a gap in the therapy of at least 60 days between prescription fill dates and their administration.

    5. Duration of Index Medication Persistent Therapy During 12 Months Post-index Date [During 12 months post-index date]

      Index medication persistent therapy duration was defined as days to discontinue or immediate switch or end of 12 months post-index follow if participants remained persistent, whichever came first. Index medications were tofacitinib, adalimumab or etanercept. Persistent with the index medication: not having a gap in the therapy of at least 60 days between prescription fill dates and their administration. Discontinuation from index medication: gap in the index medication therapy of at least 60 days. Immediate switch from index medication: initiation of a non-index advanced therapy before end of a 60-day gap in index medication.

    6. Percentage of Participants Who Were Persistent With Main Non-Biologic Disease Modifying Antirheumatic Drugs (NB-DMARD) During 12 Months Post-index Date: Combination Therapy [During 12 months post-index date]

      Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who were persistent with main NB-DMARDs use. Main NB-DMARDs considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Persistence with main NB-DMARDs was defined as not having a gap of at least 60 days between prescription fill dates and their administration.

    7. Percentage of Participants Who Immediately Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy [During 12 months post-index date]

      Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who immediately switched from main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Immediate switch from main NB-DMARDs was defined as initiation of other medication than main NB-DMARDs, before end of a 60-day gap.

    8. Percentage of Participants Who Discontinued Then Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy [During 12 months post-index date]

      Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who discontinued then switched from main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Participants who discontinued main NB-DMARDs then switched from main NB-DMARDS were those who had gap in the main NB-DMARDs medication of at least 60 days and then after the gap switched to other medication than main NB-DMARDs.

    9. Percentage of Participants Who Discontinued Then Restarted Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy [During 12 months post-index date]

      Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who discontinued then restarted main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Participants who discontinued main NB-DMARDs and then restarted main NB-DMARDs were those who had a gap in main NB-DMARDs of at least 60 days and after the gap, they started main NB-DMARDs again.

    10. Percentage of Participants Who Discontinued Without Switching or Restarting Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy [During 12 months post-index date]

      Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who discontinued without switching or restarting main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Participants who discontinued main NB-DMARDs without switching or restarting main NB-DMARDs were those who had a gap in main NB-DMARDs of at least 60 days and there were no claims for either the main NB-DMARDs or a different therapy for the remainder of the follow-up period.

    11. Percentage of Participants Who Initiated Index Medication as Monotherapy and Eventually Added NB-DMARDs During 12 Months Post-index Date [During 12 months post-index date]

      Percentage of participants who initiated only index medication and then eventually also added any NB-DMARDs, 1 of the 4 mains NB-DMARDs or other than these 4 NB-DMARDs in their therapy, were evaluated. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Any NB-DMARDs included those participants who received any of the NB-DMARDs and participant was counted only once if took different NB-DMARDs during the follow-up period. Participants might be counted more than once in categories except category "Any NB-DMARDs". Index medications were tofacitinib, adalimumab or etanercept.

    12. Percentage of Participants Who Met Adherence Effectiveness Criteria During 12 Months Post-index Date [During 12 months post-index date]

      A proportion of days covered (PDC) was calculated based on total days' supply over the 12 months post-index. The PDC was calculated by using the date of service and the day supply for each fill of the index medication. Participants with early refills were allowed to stockpile medications up to a maximum of 14 days total for later use. Participants who met adherence effective criteria were those who had PDC >=0.8. Index medications were tofacitinib, adalimumab or etanercept.

    13. Percentage of Participants Who Met Dose Escalation Effectiveness Criteria During 12 Months Post-index Date [During 12 months post-index date]

      Dose escalation for index medication was defined as: 1) for adalimumab: at least 1 claim in the 12 months post-index follow-up with an average weekly dose of at least 40 milligram per week (mg/week), 2) for etanercept: at least 1 claim in the 12 months post-index follow-up with an average weekly dose of at least 100 mg/week, 3) for tofacitinib: at least 1 claim in the 12 months post-index follow-up with an average weekly dose of at least 20 milligram per day (mg/day) for immediate release and 22 mg/day for extended release. Participants who met dose escalation effectiveness criteria were those who did not have any dose escalation for index medication compared to the starting dose.

    14. Percentage of Participants Who Met Switched Effectiveness Criteria During 12 Months Post-index Date [During 12 months post-index date]

      A switch for this outcome measure was defined as use of a different biologic disease modifying antirheumatic drug (B-DMARDs) or Janus kinase inhibitor (JAKi), any time during the 12 months post-index follow-up. Participants who met switched effectiveness criteria were those who did not switch from the index medication to B-DMARDs or JAKi. Index medications were tofacitinib, adalimumab or etanercept.

    15. Percentage of Participants Who Met NB-DMARD Effectiveness Criteria During 12 Months Post-index Date [During 12 months post-index date]

      Participants who started only index medication regimen (as monotherapy), but eventually initiated main NB-DMARDs were identified in the 12 months post-index follow-up period as adding new NB-DMARD. Participants who started index medication regimen along with any of the main NB-DMARDs (combination therapy), presence of a different NB-DMARD in 12 months post-index was identified as adding new NB-DMARD. Participants who met NB-DMARD effectiveness criteria were those who did not add a new NB-DMARD in the 12 months post-index follow up. Index medications were tofacitinib, adalimumab or etanercept.

    16. Percentage of Participants Who Met Oral Glucocorticoid Effectiveness Criteria During 12 Months Post-index Date [During 12 months post-index date]

      Oral glucocorticoid effectiveness criteria for participants with no claims for oral glucocorticoid prescriptions in the 6 months prior to the index date = did not receive more than 30 days of oral glucocorticoids between (index date + 89 days) to (index date + 359 days). 30 days of oral glucocorticoids was determined by summing up the day supply of all glucocorticoids claims with a fill date between (index date + 89 days) to (index date + 359 days). Oral glucocorticoid effectiveness criteria for participants with claims for oral glucocorticoids during the 6 months prior to the index date = no increase in oral glucocorticoid dose >=20% during months 6-12 after index compared to the 6 months before the index date. Increase in oral glucocorticoids was determined from the prednisone equivalent dose for all glucocorticoid claims filled.

    17. Percentage of Participants Who Met Infusion Glucocorticoid Effectiveness Criteria During 12 Months Post-index Date [During 12 months post-index date]

      Glucocorticoid infusion effectiveness criteria was receiving of maximum of 1 parenteral or intra-articular glucocorticoid joint injection on unique days (between [index date + 89 days] to [index date + 359 days]) after the participants had been on treatment with index medication for more than 3 months. Index medications were tofacitinib, adalimumab or etanercept.

    18. Mean of Rheumatoid Arthritis (RA) Related Inpatient Visits During 12 Months Pre-index Date [During 12 months pre-index date]

      Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits related to RA during 12 months pre-index were evaluated.

    19. Mean of Rheumatoid Arthritis Related Emergency Department (ED) Visits During 12 Months Pre-Index Date [During 12 months pre-index date]

      In this outcome measure, mean of number of emergency department visits related to RA during 12 months pre-index were evaluated.

    20. Mean of Rheumatoid Arthritis Related Outpatient Visits During 12 Months Pre-index Date [During 12 months pre-index date]

      Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits related to RA during 12 months pre-index were evaluated.

    21. Mean of Rheumatoid Arthritis-Related Pharmacy Visits During 12 Months Pre-index Date [During 12 months pre-index date]

      In this outcome measure, mean of number of pharmacy visits related to RA during 12 months pre-index were evaluated.

    22. Mean of Rheumatoid Arthritis Related Inpatient Visits During 12 Months Post-index Date [During 12 months post-index date]

      Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits related to RA during 12 months post-index were evaluated.

    23. Mean of Rheumatoid Arthritis Related Emergency Department (ED) Visits During 12 Months Post-index Date [During 12 months post-index date]

      In this outcome measure, mean of number of emergency department visits related to RA during 12 months post-index were evaluated.

    24. Mean of Rheumatoid Arthritis Related Outpatient Visits During 12 Months Post-index Date [During 12 months post-index date]

      Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits related to RA during 12 months post-index were evaluated.

    25. Mean of Rheumatoid Arthritis Related Pharmacy Visits During 12 Months Post-index Date [During 12 months post-index date]

      In this outcome measure, mean of number of pharmacy visits related to RA during 12 months post-index were evaluated.

    26. Mean of All Cause Inpatient Visits During 12 Months Pre-Index Date [During 12 months pre-index date]

      Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits regardless of reason (including related to RA) during 12 months pre-index were evaluated.

    27. Mean of All Cause Emergency Department (ED) Visits During 12 Months Pre-index Date [During 12 months pre-index date]

      In this outcome measure, mean of number of emergency department visits regardless of reason (including related to RA) during 12 months pre-index were evaluated.

    28. Mean of All Cause Outpatient Visits During 12 Months Pre-Index Date [During 12 months pre-index date]

      Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits regardless of reason (including related to RA) during 12 months pre-index were evaluated.

    29. Mean of All Cause Pharmacy Visits During 12 Months Pre-index Date [During 12 months pre-index date]

      In this outcome measure, mean of number of pharmacy visits regardless of reason (including related to RA) during 12 months pre-index were evaluated.

    30. Mean of All Cause Inpatient Visits During 12 Months Post-index Date [During 12 months post-index date]

      Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits regardless of reason (including related to RA) during 12 months post-index were evaluated.

    31. Mean of All Cause Emergency Department (ED) Visits During 12 Months Post-index Date [During 12 months post-index date]

      In this outcome measure, mean of number of emergency department visits regardless of reason (including related to RA) during 12 months post-index were evaluated.

    32. Mean of All Cause Outpatient Visits During 12 Months Post-index Date [During 12 months post-index date]

      Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits regardless of reason (including related to RA) during 12 months post-index were evaluated.

    33. Mean of All Cause Pharmacy Visits During 12 Months Post-index Date [During 12 months post-index date]

      In this outcome measure, mean of number of pharmacy visits regardless of reason (including related to RA) during 12 months post-index were evaluated.

    34. Mean of Rheumatoid Arthritis Related Total Health Care Cost During 12 Months Pre-index Date [During 12 months pre-index date]

      Total health care cost related to RA was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment costs (pharmacy cost) related to rheumatoid arthritis.

    35. Mean of Rheumatoid Arthritis Related Total Health Care Cost During 12 Months Post-index Date [During 12 months post-index date]

      Total health care cost related to RA was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment costs (pharmacy cost) related to rheumatoid arthritis.

    36. All Cause Total Health Care Cost During 12 Months Pre-index Date [During 12 months pre-index date]

      All cause total health care cost was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment cost (pharmacy cost) regardless of reason including RA.

    37. All Cause Total Health Care Cost During 12 Months Post-index Date [During 12 months post-index date]

      All cause total health care cost was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment cost (pharmacy cost) regardless of reason including RA.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • first pharmacy claim for Tofacitinib and then Etanercept or Adalimumab between Jan 2014 and Sep 2016 represents the index claim

    • First, select patients receiving ≥1 Tofacitinib pharmacy claim (Jan 2014-Sep 2016) who did not have a Tofacitinib claim anytime prior to index

    • Patients do have >1 advanced therapy filled on index date

    • Physician diagnosis of Rheumatoid Arthritis (in any position) during the 1-year pre-index period, or on the index date

    • Age 18+ years at index

    Exclusion Criteria:

    -None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Collegeville Pennsylvania United States 19426

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT04047121
    Other Study ID Numbers:
    • A3921346
    First Posted:
    Aug 6, 2019
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    Participant Flow

    Recruitment Details 5-years data were retrieved from insurance claims Truven Health MarketScan Research Databases and were evaluated in 5 months of this retrospective, observational study. Participants who initiated treatment with tofacitinib, adalimumab or etanercept for rheumatoid arthritis (RA), between January 2014 and September 2016 were involved in this study.
    Pre-assignment Detail 5-years (January 2012 to September 2017) included pre-index of 2 years, 2 years to capture treatment initiation (index date), and 1 year for follow-up post-index. Index date was first prescription date of treatment (tofacitinib, adalimumab or etanercept) from January 2014 to September 2016.
    Arm/Group Title Tofacitinib Low Out of Pocket (OOP) Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Period Title: Overall Study
    STARTED 310 299 79 287 112 262
    COMPLETED 310 299 79 287 112 262
    NOT COMPLETED 0 0 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib Total
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases. Total of all reporting groups
    Overall Participants 310 299 79 287 112 262 1349
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    58.67
    (12.93)
    54.44
    (11.01)
    50.52
    (11.60)
    55.15
    (11.14)
    53.36
    (12.05)
    54.50
    (12.25)
    55.26
    (12.03)
    Sex: Female, Male (Count of Participants)
    Female
    248
    80%
    240
    80.3%
    62
    78.5%
    243
    84.7%
    85
    75.9%
    219
    83.6%
    1097
    81.3%
    Male
    62
    20%
    59
    19.7%
    17
    21.5%
    44
    15.3%
    27
    24.1%
    43
    16.4%
    252
    18.7%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Geographic Region (Count of Participants)
    Northeast Region
    97
    31.3%
    61
    20.4%
    12
    15.2%
    58
    20.2%
    17
    15.2%
    57
    21.8%
    302
    22.4%
    North Central Region
    68
    21.9%
    61
    20.4%
    16
    20.3%
    55
    19.2%
    30
    26.8%
    43
    16.4%
    273
    20.2%
    South Region
    108
    34.8%
    135
    45.2%
    41
    51.9%
    137
    47.7%
    41
    36.6%
    128
    48.9%
    590
    43.7%
    West Region
    37
    11.9%
    42
    14%
    10
    12.7%
    34
    11.8%
    24
    21.4%
    34
    13%
    181
    13.4%
    Unknown Region
    0
    0%
    0
    0%
    0
    0%
    3
    1%
    0
    0%
    0
    0%
    3
    0.2%
    Pre-index Biologic Disease Modifying Antirheumatic Drugs (bDMARDs) Use (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    0
    0%
    52
    65.8%
    238
    82.9%
    87
    77.7%
    224
    85.5%
    601
    44.6%
    Pre-index Non-biological Disease Modifying Antirheumatic Drug (NB-DMARDs) Use (Count of Participants)
    Count of Participants [Participants]
    245
    79%
    243
    81.3%
    64
    81%
    226
    78.7%
    79
    70.5%
    198
    75.6%
    1055
    78.2%
    Disease Duration (Days) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Days]
    511.92
    (310.83)
    563.50
    (317.53)
    452.04
    (254.00)
    685.60
    (313.28)
    432.03
    (216.31)
    640.35
    (278.94)
    575.11
    (308.02)
    Pre-index Claims-based Index For Rheumatoid Arthritis Severity (CIRAS) (Units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Units on a scale]
    4.50
    (1.62)
    4.94
    (1.48)
    5.15
    (1.51)
    4.71
    (1.44)
    4.61
    (1.29)
    4.65
    (1.47)
    4.72
    (1.50)
    Quan-Charlson Score (Count of Participants)
    0
    1
    0.3%
    0
    0%
    0
    0%
    0
    0%
    2
    1.8%
    1
    0.4%
    4
    0.3%
    1-2
    235
    75.8%
    244
    81.6%
    65
    82.3%
    226
    78.7%
    91
    81.3%
    208
    79.4%
    1069
    79.2%
    3-4
    52
    16.8%
    46
    15.4%
    10
    12.7%
    52
    18.1%
    15
    13.4%
    37
    14.1%
    212
    15.7%
    Greater than or equal to (>=) 5
    22
    7.1%
    9
    3%
    4
    5.1%
    9
    3.1%
    4
    3.6%
    16
    6.1%
    64
    4.7%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Who Were Persistent With Index Medication During 12 Months Post-index Date
    Description Persistent with the index medication was defined as not having a gap in the therapy of at least 60 days between prescription fill dates and their administration. Index medications were tofacitinib, adalimumab or etanercept.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Number [Percentage of participants]
    47.42
    15.3%
    42.81
    14.3%
    36.71
    46.5%
    50.52
    17.6%
    38.39
    34.3%
    45.80
    17.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2531
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0295
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1857
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3297
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.8401
    Confidence Interval (2-Sided) 95%
    0.5919 to 1.1925
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2003
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.5066
    Confidence Interval (2-Sided) 95%
    0.8046 to 2.8209
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2276
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.4052
    Confidence Interval (2-Sided) 95%
    0.8086 to 2.4420
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title Percentage of Participants Who Immediately Switched Index Medication During 12 Months Post-index Date
    Description Participants who switched from index medication immediately were those who initiated a non-index advanced therapy before end of a 60-day gap in index medication. Index medications were tofacitinib, adalimumab or etanercept.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Number [Percentage of participants]
    10.32
    3.3%
    10.70
    3.6%
    22.78
    28.8%
    15.33
    5.3%
    25.89
    23.1%
    22.90
    8.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8786
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1178
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5337
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9212
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.0283
    Confidence Interval (2-Sided) 95%
    0.5911 to 1.7890
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4693
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.7464
    Confidence Interval (2-Sided) 95%
    0.3380 to 1.6482
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5593
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.8212
    Confidence Interval (2-Sided) 95%
    0.4239 to 1.5910
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Primary Outcome
    Title Percentage of Participants Who Discontinued Then Switched Index Medication During 12 Months Post-index Date
    Description Participants who discontinued index medication then switched from index medication were those who had gap in the index medication therapy of at least 60 days and then after the gap they switched to an advanced therapy different from index medication. Index medications were tofacitinib, adalimumab or etanercept.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Number [Percentage of participants]
    3.87
    1.2%
    4.68
    1.6%
    8.86
    11.2%
    6.62
    2.3%
    7.14
    6.4%
    5.34
    2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6205
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4924
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4982
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5494
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.3182
    Confidence Interval (2-Sided) 95%
    0.5335 to 3.2570
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7830
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.1664
    Confidence Interval (2-Sided) 95%
    0.3900 to 3.4883
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Primary Outcome
    Title Percentage of Participants Who Discontinued Then Restarted Index Medication During 12 Months Post-index Date
    Description Participants who discontinued index medication and then restarted index medication were those who had a gap in the index medication therapy of at least 60 days and the first advanced therapy observed after the gap was the index medication. Index medications were tofacitinib, adalimumab or etanercept.
    Time Frame During 12 months post index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Number [Percentage of participants]
    13.23
    4.3%
    15.72
    5.3%
    11.39
    14.4%
    10.10
    3.5%
    11.61
    10.4%
    10.69
    4.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3817
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7397
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7942
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7924
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.0682
    Confidence Interval (2-Sided) 95%
    0.6537 to 1.7455
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9339
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.0414
    Confidence Interval (2-Sided) 95%
    0.3997 to 2.7134
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6497
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.8195
    Confidence Interval (2-Sided) 95%
    0.3470 to 1.9350
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Primary Outcome
    Title Percentage of Participants Who Discontinued Without Switching or Restarting Index Medication During 12 Months Post-index Date
    Description Participants who discontinued index medication without switching or restarting index medication were those who had a gap in index medication therapy of at least 60 days and there were no claims for either the index medication or a different advanced therapy for the remainder of the follow-up period. Index medications were tofacitinib, adalimumab or etanercept.
    Time Frame During 12 months post index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Number [Percentage of participants]
    25.16
    8.1%
    26.09
    8.7%
    20.25
    25.6%
    17.42
    6.1%
    16.96
    15.1%
    15.27
    5.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7936
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5621
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6800
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5051
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.1438
    Confidence Interval (2-Sided) 95%
    0.7705 to 1.6978
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7131
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.8576
    Confidence Interval (2-Sided) 95%
    0.3781 to 1.9452
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6490
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.8415
    Confidence Interval (2-Sided) 95%
    0.4003 to 1.7690
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Percentage of Participants Who Switched Index Medication Any Time During 12 Months Post-index Date
    Description Participants who switched from index medication at any time during the 12-month follow-up post-index period were evaluated. Index medications were tofacitinib, adalimumab or etanercept.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Number [Percentage of participants]
    14.19
    4.6%
    16.05
    5.4%
    34.18
    43.3%
    23.00
    8%
    35.71
    31.9%
    29.77
    11.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5217
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0432
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2573
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5368
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.1637
    Confidence Interval (2-Sided) 95%
    0.7193 to 1.8827
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4685
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.7757
    Confidence Interval (2-Sided) 95%
    0.3904 to 1.5413
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3112
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.7354
    Confidence Interval (2-Sided) 95%
    0.4057 to 1.3330
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Mean of Number of Days to Immediate Switch From Index Medication During 12 Months Post-index Date
    Description Participants who switched from index medication immediately were those who initiated a non-index advanced therapy before the end of a 60-day gap in index medication. Index medications were tofacitinib, adalimumab or etanercept. Number of days to immediately switch from index medication = immediate switch date - index date + 1.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. Here, "Overall Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 32 32 18 44 29 60
    Mean (Standard Deviation) [Days]
    155.00
    (91.02)
    149.56
    (88.40)
    144.00
    (59.64)
    125.84
    (84.73)
    148.69
    (73.22)
    145.37
    (87.59)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8122
    Comments
    Method Log Rank
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7766
    Comments
    Method Log Rank
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8305
    Comments
    Method Log Rank
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1845
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.5814
    Confidence Interval (2-Sided) 95%
    0.2610 to 1.2952
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2951
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.5908
    Confidence Interval (2-Sided) 95%
    0.6671 to 3.7936
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4907
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.3546
    Confidence Interval (2-Sided) 95%
    0.6584 to 2.7870
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Mean of Number of Days to Immediate or Delayed Switch Index Medication During 12 Months Post-index Date
    Description Number of days to immediate or delayed switch from index medication any time during the 12-month follow-up period = immediate or delayed switch date - index date + 1. Index medications were tofacitinib, adalimumab or etanercept.
    Time Frame During 12 month post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. Here, "Overall Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 44 48 27 66 40 78
    Mean (Standard Deviation) [Days]
    168.11
    (84.29)
    175.98
    (90.52)
    182.70
    (83.90)
    158.71
    (90.81)
    170.73
    (81.64)
    169.36
    (96.58)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6006
    Comments
    Method Log Rank
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2941
    Comments
    Method Log Rank
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9610
    Comments
    Method Log Rank
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0455
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.5571
    Confidence Interval (2-Sided) 95%
    0.3140 to 0.9884
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0274
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 2.1781
    Confidence Interval (2-Sided) 95%
    1.0904 to 4.3506
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6787
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.8896
    Confidence Interval (2-Sided) 95%
    0.5114 to 1.5475
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Mean of Number of Days to Discontinue Index Medication During 12 Months Post-index Date
    Description Number of days to discontinue index medication = date of last persistent index medication prescription/administration + days supply- index date + 1. Index medications were tofacitinib, adalimumab or etanercept. Persistent with the index medication was defined as not having a gap in the therapy of at least 60 days between prescription fill dates and their administration.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. Here, "Overall Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 158 168 50 139 68 138
    Mean (Standard Deviation) [Days]
    119.62
    (80.01)
    106.17
    (76.50)
    111.74
    (74.97)
    109.42
    (74.16)
    130.18
    (70.71)
    118.91
    (77.58)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9084
    Comments
    Method Log Rank
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8325
    Comments
    Method Log Rank
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9630
    Comments
    Method Log Rank
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7909
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.0508
    Confidence Interval (2-Sided) 95%
    0.7284 to 1.5160
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6027
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.8117
    Confidence Interval (2-Sided) 95%
    0.3700 to 1.7808
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6978
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.1742
    Confidence Interval (2-Sided) 95%
    0.5222 to 2.6404
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Duration of Index Medication Persistent Therapy During 12 Months Post-index Date
    Description Index medication persistent therapy duration was defined as days to discontinue or immediate switch or end of 12 months post-index follow if participants remained persistent, whichever came first. Index medications were tofacitinib, adalimumab or etanercept. Persistent with the index medication: not having a gap in the therapy of at least 60 days between prescription fill dates and their administration. Discontinuation from index medication: gap in the index medication therapy of at least 60 days. Immediate switch from index medication: initiation of a non-index advanced therapy before end of a 60-day gap in index medication.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Days]
    235.60
    (133.02)
    273.50
    (136.81)
    203.65
    (133.21)
    239.02
    (134.51)
    219.75
    (126.09)
    234.34
    (131.10)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1736
    Comments
    Method Log Rank
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0195
    Comments
    Method Log Rank
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2104
    Comments
    Method Log Rank
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1670
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.1723
    Confidence Interval (2-Sided) 95%
    0.9357 to 1.4687
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1087
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.7228
    Confidence Interval (2-Sided) 95%
    0.4861 to 1.0747
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3212
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.8402
    Confidence Interval (2-Sided) 95%
    0.5957 to 1.1852
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Percentage of Participants Who Were Persistent With Main Non-Biologic Disease Modifying Antirheumatic Drugs (NB-DMARD) During 12 Months Post-index Date: Combination Therapy
    Description Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who were persistent with main NB-DMARDs use. Main NB-DMARDs considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Persistence with main NB-DMARDs was defined as not having a gap of at least 60 days between prescription fill dates and their administration.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. Here, "Overall Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 157 145 44 151 57 105
    Number [Percentage of participants]
    36.31
    11.7%
    35.86
    12%
    36.36
    46%
    43.71
    15.2%
    38.60
    34.5%
    42.86
    16.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9361
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3851
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5990
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9860
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.9954
    Confidence Interval (2-Sided) 95%
    0.5962 to 1.6620
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5813
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.2959
    Confidence Interval (2-Sided) 95%
    0.5158 to 3.2558
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1789
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.8182
    Confidence Interval (2-Sided) 95%
    0.7604 to 4.3473
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    12. Secondary Outcome
    Title Percentage of Participants Who Immediately Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy
    Description Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who immediately switched from main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Immediate switch from main NB-DMARDs was defined as initiation of other medication than main NB-DMARDs, before end of a 60-day gap.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. Here, "Overall Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 157 145 44 151 57 105
    Number [Percentage of participants]
    30.57
    9.9%
    26.21
    8.8%
    22.73
    28.8%
    22.52
    7.8%
    31.58
    28.2%
    23.81
    9.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4009
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9765
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2849
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5289
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.8252
    Confidence Interval (2-Sided) 95%
    0.4538 to 1.5007
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9270
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.9408
    Confidence Interval (2-Sided) 95%
    0.2553 to 3.4678
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0707
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.3968
    Confidence Interval (2-Sided) 95%
    0.1456 to 1.0812
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Secondary Outcome
    Title Percentage of Participants Who Discontinued Then Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy
    Description Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who discontinued then switched from main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Participants who discontinued main NB-DMARDs then switched from main NB-DMARDS were those who had gap in the main NB-DMARDs medication of at least 60 days and then after the gap switched to other medication than main NB-DMARDs.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. Here, "Overall Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 157 145 44 151 57 105
    Number [Percentage of participants]
    2.55
    0.8%
    0.69
    0.2%
    6.82
    8.6%
    2.65
    0.9%
    0.00
    0%
    0.00
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2061
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1908
    Comments
    Method Chi-squared
    Comments
    14. Secondary Outcome
    Title Percentage of Participants Who Discontinued Then Restarted Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy
    Description Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who discontinued then restarted main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Participants who discontinued main NB-DMARDs and then restarted main NB-DMARDs were those who had a gap in main NB-DMARDs of at least 60 days and after the gap, they started main NB-DMARDs again.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. Here, "Overall Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 157 145 44 151 57 105
    Number [Percentage of participants]
    13.38
    4.3%
    12.41
    4.2%
    13.64
    17.3%
    11.26
    3.9%
    21.05
    18.8%
    18.10
    6.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8033
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6669
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6477
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5509
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.7948
    Confidence Interval (2-Sided) 95%
    0.3736 to 1.6907
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6216
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.6814
    Confidence Interval (2-Sided) 95%
    0.1486 to 3.1250
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5506
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.6974
    Confidence Interval (2-Sided) 95%
    0.2135 to 2.2781
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    15. Secondary Outcome
    Title Percentage of Participants Who Discontinued Without Switching or Restarting Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy
    Description Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who discontinued without switching or restarting main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Participants who discontinued main NB-DMARDs without switching or restarting main NB-DMARDs were those who had a gap in main NB-DMARDs of at least 60 days and there were no claims for either the main NB-DMARDs or a different therapy for the remainder of the follow-up period.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation. Here, "Overall Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 157 145 44 151 57 105
    Number [Percentage of participants]
    17.20
    5.5%
    24.83
    8.3%
    20.45
    25.9%
    19.87
    6.9%
    8.77
    7.8%
    15.24
    5.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1030
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9317
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2420
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0869
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.7474
    Confidence Interval (2-Sided) 95%
    0.9222 to 3.3107
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8228
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.1346
    Confidence Interval (2-Sided) 95%
    0.3757 to 3.4266
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4855
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.5650
    Confidence Interval (2-Sided) 95%
    0.4446 to 5.5086
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    16. Secondary Outcome
    Title Percentage of Participants Who Initiated Index Medication as Monotherapy and Eventually Added NB-DMARDs During 12 Months Post-index Date
    Description Percentage of participants who initiated only index medication and then eventually also added any NB-DMARDs, 1 of the 4 mains NB-DMARDs or other than these 4 NB-DMARDs in their therapy, were evaluated. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Any NB-DMARDs included those participants who received any of the NB-DMARDs and participant was counted only once if took different NB-DMARDs during the follow-up period. Participants might be counted more than once in categories except category "Any NB-DMARDs". Index medications were tofacitinib, adalimumab or etanercept.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Any NB-DMARD
    29.41
    9.5%
    28.57
    9.6%
    48.57
    61.5%
    25.74
    9%
    34.55
    30.8%
    26.75
    10.2%
    Methotrexate
    16.99
    5.5%
    11.69
    3.9%
    22.86
    28.9%
    14.71
    5.1%
    27.27
    24.3%
    12.74
    4.9%
    Sulfasalazine
    1.96
    0.6%
    2.60
    0.9%
    8.57
    10.8%
    2.21
    0.8%
    5.45
    4.9%
    1.91
    0.7%
    Leflunomide
    3.92
    1.3%
    5.19
    1.7%
    17.14
    21.7%
    5.15
    1.8%
    3.64
    3.3%
    6.37
    2.4%
    Hydroxychloroquine
    8.50
    2.7%
    9.09
    3%
    20.00
    25.3%
    3.68
    1.3%
    5.45
    4.9%
    5.10
    1.9%
    Other NB-DMARD
    3.27
    1.1%
    3.90
    1.3%
    2.86
    3.6%
    1.47
    0.5%
    0.00
    0%
    4.46
    1.7%
    17. Secondary Outcome
    Title Percentage of Participants Who Met Adherence Effectiveness Criteria During 12 Months Post-index Date
    Description A proportion of days covered (PDC) was calculated based on total days' supply over the 12 months post-index. The PDC was calculated by using the date of service and the day supply for each fill of the index medication. Participants with early refills were allowed to stockpile medications up to a maximum of 14 days total for later use. Participants who met adherence effective criteria were those who had PDC >=0.8. Index medications were tofacitinib, adalimumab or etanercept.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Number [Percentage of participants]
    38.71
    12.5%
    36.12
    12.1%
    30.38
    38.5%
    44.95
    15.7%
    33.04
    29.5%
    38.93
    14.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5092
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0201
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2799
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5772
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.9021
    Confidence Interval (2-Sided) 95%
    0.6281 to 1.2958
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3272
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.3953
    Confidence Interval (2-Sided) 95%
    0.7166 to 2.7169
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3011
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.3527
    Confidence Interval (2-Sided) 95%
    0.7630 to 2.3983
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    18. Secondary Outcome
    Title Percentage of Participants Who Met Dose Escalation Effectiveness Criteria During 12 Months Post-index Date
    Description Dose escalation for index medication was defined as: 1) for adalimumab: at least 1 claim in the 12 months post-index follow-up with an average weekly dose of at least 40 milligram per week (mg/week), 2) for etanercept: at least 1 claim in the 12 months post-index follow-up with an average weekly dose of at least 100 mg/week, 3) for tofacitinib: at least 1 claim in the 12 months post-index follow-up with an average weekly dose of at least 20 milligram per day (mg/day) for immediate release and 22 mg/day for extended release. Participants who met dose escalation effectiveness criteria were those who did not have any dose escalation for index medication compared to the starting dose.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Number [Percentage of participants]
    96.13
    31%
    94.31
    31.5%
    97.47
    123.4%
    94.77
    33%
    81.25
    72.5%
    95.80
    36.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2931
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3135
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6772
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.8369
    Confidence Interval (2-Sided) 95%
    0.3618 to 1.9356
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0013
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.2530
    Confidence Interval (2-Sided) 95%
    1.9061 to 14.4770
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    19. Secondary Outcome
    Title Percentage of Participants Who Met Switched Effectiveness Criteria During 12 Months Post-index Date
    Description A switch for this outcome measure was defined as use of a different biologic disease modifying antirheumatic drug (B-DMARDs) or Janus kinase inhibitor (JAKi), any time during the 12 months post-index follow-up. Participants who met switched effectiveness criteria were those who did not switch from the index medication to B-DMARDs or JAKi. Index medications were tofacitinib, adalimumab or etanercept.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Number [Percentage of participants]
    85.81
    27.7%
    83.95
    28.1%
    65.82
    83.3%
    77.00
    26.8%
    64.29
    57.4%
    70.23
    26.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5217
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0432
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2573
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5368
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.8593
    Confidence Interval (2-Sided) 95%
    0.5311 to 1.3902
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4685
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.2892
    Confidence Interval (2-Sided) 95%
    0.6488 to 2.5616
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3112
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.3598
    Confidence Interval (2-Sided) 95%
    0.7502 to 2.4648
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    20. Secondary Outcome
    Title Percentage of Participants Who Met NB-DMARD Effectiveness Criteria During 12 Months Post-index Date
    Description Participants who started only index medication regimen (as monotherapy), but eventually initiated main NB-DMARDs were identified in the 12 months post-index follow-up period as adding new NB-DMARD. Participants who started index medication regimen along with any of the main NB-DMARDs (combination therapy), presence of a different NB-DMARD in 12 months post-index was identified as adding new NB-DMARD. Participants who met NB-DMARD effectiveness criteria were those who did not add a new NB-DMARD in the 12 months post-index follow up. Index medications were tofacitinib, adalimumab or etanercept.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Number [Percentage of participants]
    71.61
    23.1%
    74.58
    24.9%
    64.56
    81.7%
    77.00
    26.8%
    66.96
    59.8%
    79.39
    30.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4090
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0249
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0103
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5415
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.1302
    Confidence Interval (2-Sided) 95%
    0.7630 to 1.6741
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0596
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.0118
    Confidence Interval (2-Sided) 95%
    0.9722 to 4.1632
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.4823
    Confidence Interval (2-Sided) 95%
    1.7930 to 6.7633
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    21. Secondary Outcome
    Title Percentage of Participants Who Met Oral Glucocorticoid Effectiveness Criteria During 12 Months Post-index Date
    Description Oral glucocorticoid effectiveness criteria for participants with no claims for oral glucocorticoid prescriptions in the 6 months prior to the index date = did not receive more than 30 days of oral glucocorticoids between (index date + 89 days) to (index date + 359 days). 30 days of oral glucocorticoids was determined by summing up the day supply of all glucocorticoids claims with a fill date between (index date + 89 days) to (index date + 359 days). Oral glucocorticoid effectiveness criteria for participants with claims for oral glucocorticoids during the 6 months prior to the index date = no increase in oral glucocorticoid dose >=20% during months 6-12 after index compared to the 6 months before the index date. Increase in oral glucocorticoids was determined from the prednisone equivalent dose for all glucocorticoid claims filled.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Number [Percentage of participants]
    83.55
    27%
    86.96
    29.1%
    83.54
    105.7%
    85.02
    29.6%
    86.61
    77.3%
    81.30
    31%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2361
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7474
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2118
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1978
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.3811
    Confidence Interval (2-Sided) 95%
    0.8449 to 2.2576
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8893
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.0614
    Confidence Interval (2-Sided) 95%
    0.4587 to 2.4559
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1553
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.5811
    Confidence Interval (2-Sided) 95%
    0.2748 to 1.2286
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    22. Secondary Outcome
    Title Percentage of Participants Who Met Infusion Glucocorticoid Effectiveness Criteria During 12 Months Post-index Date
    Description Glucocorticoid infusion effectiveness criteria was receiving of maximum of 1 parenteral or intra-articular glucocorticoid joint injection on unique days (between [index date + 89 days] to [index date + 359 days]) after the participants had been on treatment with index medication for more than 3 months. Index medications were tofacitinib, adalimumab or etanercept.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Number [Percentage of participants]
    83.87
    27.1%
    82.61
    27.6%
    74.68
    94.5%
    82.58
    28.8%
    83.04
    74.1%
    76.34
    29.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6767
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1141
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1497
    Comments
    Method Chi-squared
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5228
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.8556
    Confidence Interval (2-Sided) 95%
    0.5303 to 1.3804
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0277
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.5125
    Confidence Interval (2-Sided) 95%
    1.1062 to 5.7063
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3240
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.6993
    Confidence Interval (2-Sided) 95%
    0.3435 to 1.4236
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    23. Secondary Outcome
    Title Mean of Rheumatoid Arthritis (RA) Related Inpatient Visits During 12 Months Pre-index Date
    Description Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits related to RA during 12 months pre-index were evaluated.
    Time Frame During 12 months pre-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Inpatient visits]
    0.08
    (0.28)
    0.09
    (0.38)
    0.05
    (0.22)
    0.08
    (0.31)
    0.04
    (0.25)
    0.08
    (0.32)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6318
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3802
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2424
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1753
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.0347
    Confidence Interval (2-Sided) 95%
    -0.0155 to 0.0848
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6114
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.0194
    Confidence Interval (2-Sided) 95%
    -0.0553 to 0.0941
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2977
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.0345
    Confidence Interval (2-Sided) 95%
    -0.0304 to 0.0993
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    24. Secondary Outcome
    Title Mean of Rheumatoid Arthritis Related Emergency Department (ED) Visits During 12 Months Pre-Index Date
    Description In this outcome measure, mean of number of emergency department visits related to RA during 12 months pre-index were evaluated.
    Time Frame During 12 months pre-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Emergency department visits]
    0.16
    (0.53)
    0.10
    (0.44)
    0.13
    (0.54)
    0.14
    (0.44)
    0.14
    (0.75)
    0.21
    (0.94)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1473
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8747
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5265
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2522
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.0457
    Confidence Interval (2-Sided) 95%
    -0.1239 to 0.0325
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6701
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.0278
    Confidence Interval (2-Sided) 95%
    -0.1003 to 0.1559
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1017
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.1693
    Confidence Interval (2-Sided) 95%
    -0.0334 to 0.3720
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    25. Secondary Outcome
    Title Mean of Rheumatoid Arthritis Related Outpatient Visits During 12 Months Pre-index Date
    Description Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits related to RA during 12 months pre-index were evaluated.
    Time Frame During 12 months pre-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Outpatient visits]
    7.83
    (5.69)
    8.38
    (5.45)
    7.90
    (5.54)
    8.80
    (5.66)
    7.19
    (4.61)
    8.89
    (5.22)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2246
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2101
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0030
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3324
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.4140
    Confidence Interval (2-Sided) 95%
    -0.4231 to 1.2511
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1367
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.1712
    Confidence Interval (2-Sided) 95%
    -0.3713 to 2.7138
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0028
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.8099
    Confidence Interval (2-Sided) 95%
    0.6219 to 2.9978
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    26. Secondary Outcome
    Title Mean of Rheumatoid Arthritis-Related Pharmacy Visits During 12 Months Pre-index Date
    Description In this outcome measure, mean of number of pharmacy visits related to RA during 12 months pre-index were evaluated.
    Time Frame During 12 months pre-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Pharmacy visits]
    13.25
    (9.80)
    14.16
    (10.45)
    17.23
    (11.53)
    17.85
    (10.80)
    16.60
    (11.18)
    17.40
    (11.69)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2667
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6570
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5403
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1167
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.9159
    Confidence Interval (2-Sided) 95%
    -0.2283 to 2.0600
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9722
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.0336
    Confidence Interval (2-Sided) 95%
    -1.9238 to 1.8567
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8455
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.2064
    Confidence Interval (2-Sided) 95%
    -1.8689 to 2.2817
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    27. Secondary Outcome
    Title Mean of Rheumatoid Arthritis Related Inpatient Visits During 12 Months Post-index Date
    Description Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits related to RA during 12 months post-index were evaluated.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Inpatient visits]
    0.14
    (0.42)
    0.10
    (0.36)
    0.04
    (0.19)
    0.08
    (0.33)
    0.11
    (0.47)
    0.08
    (0.34)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3142
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2465
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5933
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7815
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.0089
    Confidence Interval (2-Sided) 95%
    -0.0716 to 0.0538
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4446
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.0337
    Confidence Interval (2-Sided) 95%
    -0.0528 to 0.1202
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4733
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.0333
    Confidence Interval (2-Sided) 95%
    -0.1243 to 0.0577
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    28. Secondary Outcome
    Title Mean of Rheumatoid Arthritis Related Emergency Department (ED) Visits During 12 Months Post-index Date
    Description In this outcome measure, mean of number of emergency department visits related to RA during 12 months post-index were evaluated.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Emergency department visits]
    0.18
    (0.48)
    0.12
    (0.41)
    0.11
    (0.39)
    0.08
    (0.31)
    0.29
    (1.75)
    0.23
    (0.61)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0658
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3785
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6202
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2523
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.0425
    Confidence Interval (2-Sided) 95%
    -0.1154 to 0.0303
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4068
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.0388
    Confidence Interval (2-Sided) 95%
    -0.1305 to 0.0529
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5858
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.0706
    Confidence Interval (2-Sided) 95%
    -0.1833 to 0.3244
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    29. Secondary Outcome
    Title Mean of Rheumatoid Arthritis Related Outpatient Visits During 12 Months Post-index Date
    Description Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits related to RA during 12 months post-index were evaluated.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Outpatient visits]
    8.60
    (7.17)
    8.14
    (5.72)
    7.51
    (5.53)
    8.06
    (6.08)
    8.52
    (6.68)
    8.88
    (6.32)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3832
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4631
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6202
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3158
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.5353
    Confidence Interval (2-Sided) 95%
    -1.5812 to 0.5107
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1016
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.3543
    Confidence Interval (2-Sided) 95%
    -0.2669 to 2.9755
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2576
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.8677
    Confidence Interval (2-Sided) 95%
    -0.6347 to 2.3700
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    30. Secondary Outcome
    Title Mean of Rheumatoid Arthritis Related Pharmacy Visits During 12 Months Post-index Date
    Description In this outcome measure, mean of number of pharmacy visits related to RA during 12 months post-index were evaluated.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Pharmacy visits]
    18.76
    (10.77)
    17.86
    (11.08)
    19.80
    (11.74)
    18.57
    (10.57)
    20.13
    (11.15)
    19.08
    (10.59)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3107
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3735
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3863
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1918
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -1.0337
    Confidence Interval (2-Sided) 95%
    -2.5858 to 0.5184
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4281
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.9749
    Confidence Interval (2-Sided) 95%
    -3.3864 to 1.4366
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1014
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -1.8599
    Confidence Interval (2-Sided) 95%
    -4.0854 to 0.3657
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    31. Secondary Outcome
    Title Mean of All Cause Inpatient Visits During 12 Months Pre-Index Date
    Description Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits regardless of reason (including related to RA) during 12 months pre-index were evaluated.
    Time Frame During 12 months pre-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Inpatient visits]
    0.14
    (0.39)
    0.17
    (0.54)
    0.13
    (0.43)
    0.15
    (0.43)
    0.10
    (0.46)
    0.16
    (0.48)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4555
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7164
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2456
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0962
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.0568
    Confidence Interval (2-Sided) 95%
    -0.0101 to 0.1238
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3844
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.0432
    Confidence Interval (2-Sided) 95%
    -0.1405 to 0.0541
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5899
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.0233
    Confidence Interval (2-Sided) 95%
    -0.0615 to 0.1082
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    32. Secondary Outcome
    Title Mean of All Cause Emergency Department (ED) Visits During 12 Months Pre-index Date
    Description In this outcome measure, mean of number of emergency department visits regardless of reason (including related to RA) during 12 months pre-index were evaluated.
    Time Frame During 12 months pre-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Emergency department visits]
    0.55
    (0.95)
    0.47
    (1.34)
    0.52
    (1.27)
    0.47
    (1.09)
    0.63
    (2.76)
    0.60
    (1.46)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4133
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7171
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8609
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6224
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.0445
    Confidence Interval (2-Sided) 95%
    -0.2218 to 0.1327
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5655
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.0884
    Confidence Interval (2-Sided) 95%
    -0.3900 to 0.2132
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4044
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.1809
    Confidence Interval (2-Sided) 95%
    -0.2444 to 0.6062
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    33. Secondary Outcome
    Title Mean of All Cause Outpatient Visits During 12 Months Pre-Index Date
    Description Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits regardless of reason (including related to RA) during 12 months pre-index were evaluated.
    Time Frame During 12 months pre-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Outpatient visits]
    31.70
    (22.60)
    27.26
    (19.81)
    28.48
    (23.30)
    29.92
    (20.62)
    27.23
    (18.21)
    31.45
    (22.50)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0104
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5949
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0801
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0072
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -3.7075
    Confidence Interval (2-Sided) 95%
    -6.4110 to -1.0040
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5406
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -1.4296
    Confidence Interval (2-Sided) 95%
    -6.0080 to 3.1489
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8603
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.3527
    Confidence Interval (2-Sided) 95%
    -4.2790 to 3.5737
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    34. Secondary Outcome
    Title Mean of All Cause Pharmacy Visits During 12 Months Pre-index Date
    Description In this outcome measure, mean of number of pharmacy visits regardless of reason (including related to RA) during 12 months pre-index were evaluated.
    Time Frame During 12 months pre-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Pharmacy visits]
    41.69
    (30.60)
    40.56
    (27.62)
    42.47
    (27.03)
    46.24
    (29.26)
    41.83
    (28.58)
    47.29
    (33.67)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6344
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3037
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1344
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5092
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.2586
    Confidence Interval (2-Sided) 95%
    -2.4787 to 4.9958
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8047
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.7696
    Confidence Interval (2-Sided) 95%
    -6.8683 to 5.3292
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9757
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.0940
    Confidence Interval (2-Sided) 95%
    -5.9628 to 6.1507
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    35. Secondary Outcome
    Title Mean of All Cause Inpatient Visits During 12 Months Post-index Date
    Description Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits regardless of reason (including related to RA) during 12 months post-index were evaluated.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Inpatient visits]
    0.24
    (0.58)
    0.16
    (0.53)
    0.14
    (0.71)
    0.14
    (0.48)
    0.24
    (1.21)
    0.25
    (0.87)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0839
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9577
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9497
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4873
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.0310
    Confidence Interval (2-Sided) 95%
    -0.1185 to 0.0565
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6780
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.0312
    Confidence Interval (2-Sided) 95%
    -0.1783 to 0.1159
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9327
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.0099
    Confidence Interval (2-Sided) 95%
    -0.2207 to 0.2406
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    36. Secondary Outcome
    Title Mean of All Cause Emergency Department (ED) Visits During 12 Months Post-index Date
    Description In this outcome measure, mean of number of emergency department visits regardless of reason (including related to RA) during 12 months post-index were evaluated.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Emergency department visits]
    0.68
    (1.25)
    0.41
    (0.89)
    0.52
    (0.96)
    0.44
    (1.04)
    1.04
    (7.23)
    0.81
    (1.63)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5396
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6121
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0303
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.1895
    Confidence Interval (2-Sided) 95%
    -0.3610 to -0.0181
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1807
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.1901
    Confidence Interval (2-Sided) 95%
    -0.4685 to 0.0883
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7445
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.1594
    Confidence Interval (2-Sided) 95%
    -0.7991 to 1.1178
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    37. Secondary Outcome
    Title Mean of All Cause Outpatient Visits During 12 Months Post-index Date
    Description Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits regardless of reason (including related to RA) during 12 months post-index were evaluated.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Outpatient visits]
    33.30
    (29.56)
    27.16
    (21.30)
    27.00
    (21.04)
    28.89
    (22.48)
    28.39
    (22.90)
    32.76
    (27.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0035
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5040
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1366
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0820
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -3.4084
    Confidence Interval (2-Sided) 95%
    -7.2497 to 0.4330
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5845
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -1.5342
    Confidence Interval (2-Sided) 95%
    -7.0336 to 3.9652
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7284
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.9870
    Confidence Interval (2-Sided) 95%
    -4.5830 to 6.5570
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    38. Secondary Outcome
    Title Mean of All Cause Pharmacy Visits During 12 Months Post-index Date
    Description In this outcome measure, mean of number of pharmacy visits regardless of reason (including related to RA) during 12 months post-index were evaluated.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Pharmacy visits]
    49.32
    (34.05)
    45.25
    (28.85)
    46.33
    (27.41)
    47.70
    (30.26)
    45.70
    (27.46)
    50.09
    (31.99)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1125
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7156
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2056
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4288
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -1.8061
    Confidence Interval (2-Sided) 95%
    -6.2797 to 2.6675
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6303
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -1.6946
    Confidence Interval (2-Sided) 95%
    -8.5962 to 5.2069
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7477
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value -0.9873
    Confidence Interval (2-Sided) 95%
    -7.0028 to 5.0281
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    39. Secondary Outcome
    Title Mean of Rheumatoid Arthritis Related Total Health Care Cost During 12 Months Pre-index Date
    Description Total health care cost related to RA was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment costs (pharmacy cost) related to rheumatoid arthritis.
    Time Frame During 12 months pre-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Dollars]
    6316.86
    (14673.52)
    7414.19
    (16892.85)
    16343.48
    (15762.03)
    27375.50
    (20613.83)
    18432.35
    (15754.60)
    22777.88
    (16633.19)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3919
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0193
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0570
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Cost Ratio
    Estimated Value 1.2232
    Confidence Interval (2-Sided) 95%
    0.9940 to 1.5053
    Parameter Dispersion Type:
    Value:
    Estimation Comments Since health care costs were skewed, hence estimated cost was modeled using a generalized linear model (GLM). Coefficients from a generalized linear model were estimated as cost ratios.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Cost Ratio
    Estimated Value 1.8479
    Confidence Interval (2-Sided) 95%
    1.4378 to 2.3749
    Parameter Dispersion Type:
    Value:
    Estimation Comments Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0924
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Cost Ratio
    Estimated Value 1.1868
    Confidence Interval (2-Sided) 95%
    0.9722 to 1.4487
    Parameter Dispersion Type:
    Value:
    Estimation Comments Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.
    40. Secondary Outcome
    Title Mean of Rheumatoid Arthritis Related Total Health Care Cost During 12 Months Post-index Date
    Description Total health care cost related to RA was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment costs (pharmacy cost) related to rheumatoid arthritis.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Dollars]
    35601.32
    (22826.82)
    34503.47
    (31045.94)
    34010.25
    (17628.32)
    37431.71
    (21525.40)
    40027.03
    (20886.32)
    36963.17
    (18806.38)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6184
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1952
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1638
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6732
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Cost Ratio
    Estimated Value 0.9773
    Confidence Interval (2-Sided) 95%
    0.8782 to 1.0875
    Parameter Dispersion Type:
    Value:
    Estimation Comments Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6345
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Cost Ratio
    Estimated Value 0.9629
    Confidence Interval (2-Sided) 95%
    0.8240 to 1.1253
    Parameter Dispersion Type:
    Value:
    Estimation Comments Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0029
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Cost Ratio
    Estimated Value 0.8327
    Confidence Interval (2-Sided) 95%
    0.7380 to 0.9395
    Parameter Dispersion Type:
    Value:
    Estimation Comments Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.
    41. Secondary Outcome
    Title All Cause Total Health Care Cost During 12 Months Pre-index Date
    Description All cause total health care cost was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment cost (pharmacy cost) regardless of reason including RA.
    Time Frame During 12 months pre-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Dollars]
    22626.74
    (43882.45)
    19514.09
    (29958.63)
    25944.31
    (21338.45)
    38749.72
    (28956.92)
    29643.91
    (31487.43)
    36152.42
    (30954.57)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3087
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0647
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7684
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Cost Ratio
    Estimated Value 0.9762
    Confidence Interval (2-Sided) 95%
    0.8316 to 1.1460
    Parameter Dispersion Type:
    Value:
    Estimation Comments Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Cost Ratio
    Estimated Value 1.3862
    Confidence Interval (2-Sided) 95%
    1.1379 to 1.6886
    Parameter Dispersion Type:
    Value:
    Estimation Comments Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9422
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Cost Ratio
    Estimated Value 1.0065
    Confidence Interval (2-Sided) 95%
    0.8452 to 1.1985
    Parameter Dispersion Type:
    Value:
    Estimation Comments Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.
    42. Secondary Outcome
    Title All Cause Total Health Care Cost During 12 Months Post-index Date
    Description All cause total health care cost was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment cost (pharmacy cost) regardless of reason including RA.
    Time Frame During 12 months post-index date

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on all eligible participants whose data were retrieved from databases and included in the study for retrospective observation.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    Measure Participants 310 299 79 287 112 262
    Mean (Standard Deviation) [Dollars]
    56515.65
    (78961.26)
    46126.57
    (39998.62)
    50343.02
    (68582.27)
    49109.94
    (29561.43)
    56302.76
    (61613.45)
    56786.41
    (57000.99)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0421
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8137
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9416
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tofacitinib Low OOP Cost, Tofacitinib High OOP Cost
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3190
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Cost Ratio
    Estimated Value 0.9515
    Confidence Interval (2-Sided) 95%
    0.8628 to 1.0493
    Parameter Dispersion Type:
    Value:
    Estimation Comments Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Switch From Adalimumab to Etanercept, Switch From Adalimumab to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1368
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Cost Ratio
    Estimated Value 0.8991
    Confidence Interval (2-Sided) 95%
    0.7815 to 1.0343
    Parameter Dispersion Type:
    Value:
    Estimation Comments Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Switch From Etanercept to Adalimumab, Switch From Etanercept to Tofacitinib
    Comments To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0231
    Comments
    Method Regression, Linear
    Comments
    Method of Estimation Estimation Parameter Cost Ratio
    Estimated Value 0.8514
    Confidence Interval (2-Sided) 95%
    0.7411 to 0.9782
    Parameter Dispersion Type:
    Value:
    Estimation Comments Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.

    Adverse Events

    Time Frame Not applicable as safety data was not planned to be collected and evaluated during the study
    Adverse Event Reporting Description Study used de-identified structured data. Minimum criteria for reporting an adverse event (identifiable participant, identifiable reporter, a suspect product/treatment, and event) could not be met. Hence, due to the nature of claims database from which data were queried, no adverse events were collected.
    Arm/Group Title Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Arm/Group Description Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had low OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims database. Participants included in this reporting group were those who initiated tofacitinib between January 2014 and September 2016 and had high OOP cost (medical care expenses not reimbursed by insurance) as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to etanercept, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated adalimumab between January 2014 and September 2016, and in this same duration switched from adalimumab to tofacitinib as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to adalimumab, as per data retrieved from insurance claims databases. Participants included in this reporting group were those who initiated etanercept between January 2014 and September 2016, and in this same duration switched from etanercept to tofacitinib, as per data retrieved from insurance claims databases.
    All Cause Mortality
    Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
    Serious Adverse Events
    Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Tofacitinib Low OOP Cost Tofacitinib High OOP Cost Switch From Adalimumab to Etanercept Switch From Adalimumab to Tofacitinib Switch From Etanercept to Adalimumab Switch From Etanercept to Tofacitinib
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)

    Limitations/Caveats

    Prioritization for outcome measures was per study team's discretion.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT04047121
    Other Study ID Numbers:
    • A3921346
    First Posted:
    Aug 6, 2019
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Sep 1, 2020