Patient-Reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib Or Biological Disease-Modifying Antirheumatic Drugs (DMARDs) In Real Life Conditions

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03073109
• Collaborator: (none)
• Enrollment: 170
• Locations: 13
• Actual Duration (Months): 30.1
• Patients Per Site: 13.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study is aimed to describe the outcomes related to physical activity, activity of disease, quality of life, work productivity and safety in Latin-American patients with Rheumatoid Arthritis (RA) treated with tofacitinib or biological DMARDs after failure to respond to conventional DMARDs in real-life conditions. This will be a non-interventional, hybrid study (prospective and retrospective data collection) comparing tofacitinib to biologic DMARD treatments in patients with RA after failure of conventional DMARDs. The population will be composed by adult patients over 18 years of age diagnosed with RA and who have been prescribed tofacitinib or any biological DMARDs.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid

Study Design

• Study Type: Observational
• Actual Enrollment: 170 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: PATIENT-REPORTED OUTCOMES IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH TOFACITINIB OR BIOLOGICAL DISEASE-MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN REAL LIFE CONDITIONS
• Actual Study Start Date: Mar 15, 2017
• Actual Primary Completion Date: Sep 16, 2019
• Actual Study Completion Date: Sep 16, 2019

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Month 6 [Baseline, Month 6]

   Disease activity was assessed using RAPID3, which was based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain, and patient global estimate. Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give a total score=0 to 10, higher scores=greater difficulty. Pain and global estimate of health measured on Likert scale from '0'=no pain/feeling very well to '10'=pain as bad as it could be/ feeling very poorly, higher scores=greater difficulty/ worsening of condition. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Data has been provided in terms of adjusted (consider impact of co-variables) and unadjusted mean (does not consider co-variables impact).

Secondary Outcome Measures

1. Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6 [Month 6]

   Functional status of participants was assessed using adapted HAQ-DI. Adapted HAQ-DI is a participant-reported questionnaire for the assessment of ability to perform tasks in 8 categories of daily living activities due to rheumatoid arthritis: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point Likert scale from 0 to 3, where 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by total number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Data has been provided in terms of adjusted (consider impact of co-variables) and unadjusted mean (does not consider co-variables impact).

2. Change From Baseline in Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6 [Baseline, Month 6]

   Functional status of participants was assessed using adapted HAQ-DI. Adapted HAQ-DI is a participant-reported questionnaire for the assessment of ability to perform tasks in 8 categories of daily living activities due to rheumatoid arthritis: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point Likert scale from 0 to 3, where 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by total number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Data has been provided in terms of adjusted (consider impact of co-variable) and unadjusted mean (does not consider co-variable impact).

3. European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6 [Month 6]

   EQ-5D-3L is a standardized, participant-administered measure of self-reported health outcomes. It consists of two parts: EQ-5D index score (Part I) and the EQ-VAS (Part II). For Part I, i.e. EQ-5D-3L index score, participants rated their current health state on 5 single-item dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with each dimension having three levels of measure: 1= no problems, 2= some problems and 3= extreme problems. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total index score range of 0 to 1.00; higher scores indicating a better health state. Data has been provided in terms of adjusted (consider impact of co-variables) and unadjusted mean (does not consider co-variables impact).

4. Change From Baseline in European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6 [Baseline, Month 6]

   EQ-5D-3L is a standardized, participant-administered measure of self-reported health outcomes. It consists of two parts: EQ-5D index score (Part I) and the EQ-VAS (Part II). For Part I, i.e. EQ-5D-3L index score, participants rated their current health state on 5 single-item dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with each dimension having three levels of function:. 1=no problems, 2=some problems and 3=extreme problems. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total index score range of 0 to 1.00; higher scores indicating a better health state. Data has been provided in terms of adjusted (consider impact of co-variables) and unadjusted mean (does not consider co-variables impact).

5. Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6 [Month 6]

   WPAI-RA: 6-questions participant rated questionnaire that measures effect of participant's RA on general health and symptom severity on work productivity and regular activities. Consisted of 6 questions, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affected productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). It yielded four sub-scores: percent work time missed due to health (absenteeism), percent impairment while working (presenteeism), percent overall work impairment due to health (work productivity loss) and percent activity impairment due to health (daily activity impairment/loss). Sub-scores were expressed as an impairment percentage range from 0 to 100, where 0 = no impairment, 100 = completely impaired, higher scores=greater impairment and less productivity. Data has been provided in terms of adjusted and unadjusted mean.

6. Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6 [Baseline, Month 6]

   WPAI-RA: 6-questions participant rated questionnaire that measures effect of participant's RA on general health and symptom severity on work productivity and regular activities. Consisted of 6 questions, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affected productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). It yielded four sub-scores: percent work time missed due to health (absenteeism), percent impairment while working (presenteeism), percent overall work impairment due to health (work productivity loss) and percent activity impairment due to health (daily activity impairment/loss). Sub-scores were expressed as an impairment percentage range from 0 to 100, where 0 = no impairment, 100 = completely impaired, higher numbers=greater impairment and less productivity. Data has been provided in terms of adjusted and unadjusted mean.

7. Disease Activity Score Based on 28-joints Count (DAS28) at Month 6 [Month 6]

   DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, erythrocyte sedimentation rate (ESR) (measured in millimeters per hour [mm/hour]) and patient's global assessment of disease activity according to 100-millimeter (mm) Visual Analog Scale (VAS) (scores ranging 0 [very well] to 100 mm [extremely bad], higher scores=worsening of condition). DAS28-ESR scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 scores ranged from 0 to 10; higher scores indicated greater affectation due to disease activity. Data has been provided in terms of adjusted and unadjusted mean.

8. Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6 [Baseline, Month 6]

   DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, erythrocyte sedimentation rate (ESR) (measured in millimeters per hour [mm/hour]) and patient's global assessment of disease activity according to 100-millimeter (mm) Visual Analog Scale (VAS) (scores ranging 0 [very well] to 100 mm [extremely bad], higher scores=worsening of condition). DAS28-ESR scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 scores ranged from 0 to 10; higher scores indicated greater affectation due to disease activity. Data has been provided in terms of adjusted and unadjusted mean.

9. Number of Participants With Serious Adverse Event (SAE) and Non-serious Adverse Events (AEs) [Baseline up to Month 6]

   Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included both serious and non-serious adverse event. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

10. Number of Participants With Serious Infections [Baseline up to Month 6]

    Serious infection defined as any infection that requires hospitalization.

11. Number of Participants Who Withdrew From Study Due to Adverse Events And Due to All Causes [Baseline up to Month 6]

    Here, number of participants who withdrew from study due to AEs and due to all causes (withdrawals due to AEs, lost to follow up and unspecified reasons) have been described.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients ≥ 18 years of age at the time of recruitment

• Patient diagnosed with moderate to severe RA ≥ 6 months before enrollment

• Patients who have had an inadequate response to the continuous use of methotrexate or combination of conventional DMARDs for at least 12 weeks before the study without dose change within the last 8 weeks before enrollment in the study

• Patients with no biological DMARDs use in patient history.

• Patients prescribed with tofacitinib or biological DMARDs in the last two weeks at doses established in ACR guidelines published in 2015 and following medical criteria.

• Acceptance for patients to participate in the study and signing of the informed consent.

Exclusion Criteria:

• Patients who do not have the ability to answer the questionnaires by themselves or who have any kind of mental disorder that may affect their answers.

• Patients diagnosed with autoimmune rheumatic diseases other than RA and Sjogren's syndrome.

• Patients treated with biological DMARDs in monotherapy.

• Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks or 5 half-lives (whichever is longer) after discontinuation of the investigational compound before the current study begins and/or during study participation.

• Patients with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.

• Patients with lymphoproliferative disorders (e.g., Epstein Barr Virus (EBV) related lymphoproliferative disorder), a history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Artmedica	Medellin	Antioquia	Colombia
2	Fundacion Instituto de Reumatologia Fernando Chalem	Bogota	Cundinamarca	Colombia
3	IDEARG	Bogota	Cundinamarca	Colombia
4	Clinica de Occidente	Cali	Valle	Colombia
5	Centro Integral de Reumatología del Caribe Circaribe S.A	Barranquilla		Colombia
6	Clinicos IPS	Bogota		Colombia	111211
7	Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM	Bogotá		Colombia
8	SERVIMED	Bucaramanga		Colombia
9	Fundacion Valle del Lili	Cali		Colombia
10	REUMALAB	Medellin		Colombia
11	Clínica San Judas Tadeo	Lima	SAN Miguel	Peru	15086
12	Centro Medico CEEN	Arequipa		Peru
13	Clinica Jockey Salud	Lima		Peru

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 12, 2018

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03073109
• Other Study ID Numbers: A3921284
• First Posted: Mar 8, 2017
• Last Update Posted: Oct 22, 2020
• Last Verified: Oct 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	The study included participants from two Latin American countries (Colombia and Peru) from 15 March 2017 to 16 September 2019.
Pre-assignment Detail	This was a non-interventional, hybrid study (prospective and retrospective data collection).

Arm/Group Title	Tofacitinib	Biologics
Arm/Group Description	Participants with rheumatoid arthritis (RA) treated with tofacitinib after failure of conventional disease-modifying anti-rheumatic drugs (DMARDs) were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.	Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
Period Title: Overall Study
STARTED	100	70
COMPLETED	90	68
NOT COMPLETED	10	2

Baseline Characteristics

Arm/Group Title	Tofacitinib	Biologics	Total
Arm/Group Description	Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.	Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.	Total of all reporting groups
Overall Participants	100	70	170
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.0 (14.4)	51.3 (12.6)	53.5 (13.8)
Sex/Gender, Customized (Count of Participants)
Male	15 15%	4 5.7%	19 11.2%
Female	85 85%	65 92.9%	150 88.2%
Unknown	0 0%	1 1.4%	1 0.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	100 100%	69 98.6%	169 99.4%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 1.4%	1 0.6%
Race/Ethnicity, Customized (Count of Participants)
Latin American	100 100%	69 98.6%	169 99.4%
Unknown	0 0%	1 1.4%	1 0.6%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Month 6
Description	Disease activity was assessed using RAPID3, which was based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain, and patient global estimate. Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give a total score=0 to 10, higher scores=greater difficulty. Pain and global estimate of health measured on Likert scale from '0'=no pain/feeling very well to '10'=pain as bad as it could be/ feeling very poorly, higher scores=greater difficulty/ worsening of condition. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Data has been provided in terms of adjusted (consider impact of co-variables) and unadjusted mean (does not consider co-variables impact).
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Analysis was performed on all participants included in the study. Here, 'Number analyzed' = participants evaluable for this outcome measure (OM) at specified time points.

Arm/Group Title	Tofacitinib	Biologics
Arm/Group Description	Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.	Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were treatment interruption, access limitation, previous methotrexate and complementary access.
Measure Participants	100	70
Baseline - adjusted mean	7.12 (0.39)	5.95 (0.31)
Baseline - unadjusted mean	5.88 (0.22)	5.94 (0.22)
Change at Month 6 - adjusted mean	-0.20 (0.70)	-0.32 (0.72)
Change at Month 6 - unadjusted mean	-2.71 (0.26)	-3.28 (0.30)

2. Secondary Outcome

Title	Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6
Description	Functional status of participants was assessed using adapted HAQ-DI. Adapted HAQ-DI is a participant-reported questionnaire for the assessment of ability to perform tasks in 8 categories of daily living activities due to rheumatoid arthritis: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point Likert scale from 0 to 3, where 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by total number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Data has been provided in terms of adjusted (consider impact of co-variables) and unadjusted mean (does not consider co-variables impact).
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

Analysis was performed on participants included in the study who were evaluable for adapted HAQ-DI at month 6. Hence, 'Overall number of participants analyzed' = Participants who had data available for this OM.

Arm/Group Title	Tofacitinib	Biologics
Arm/Group Description	Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were time to supply, access limitation, methotrexate concomitant, chloro-quine concomitant and participant access.	Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were sensitive joints, leflunomide concomitant, chloro-quine concomitant and public access.
Measure Participants	90	68
Adjusted mean	0.93 (0.13)	0.77 (0.10)
Unadjusted mean	0.96 (0.08)	0.78 (0.08)

3. Secondary Outcome

Title	Change From Baseline in Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6
Description	Functional status of participants was assessed using adapted HAQ-DI. Adapted HAQ-DI is a participant-reported questionnaire for the assessment of ability to perform tasks in 8 categories of daily living activities due to rheumatoid arthritis: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point Likert scale from 0 to 3, where 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by total number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Data has been provided in terms of adjusted (consider impact of co-variable) and unadjusted mean (does not consider co-variable impact).
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Analysis was performed on all participants included in the study. Here, 'Number analyzed' = participants evaluable for this OM at specified time points.

Arm/Group Title	Tofacitinib	Biologics
Arm/Group Description	Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variable considered for adjusted mean was access limitation.	Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variable considered for adjusted mean was access limitation.
Measure Participants	100	70
Baseline - adjusted mean	1.63 (0.13)	1.50 (0.10)
Baseline - unadjusted mean	1.62 (0.08)	1.46 (0.08)
Change at Month 6 - adjusted mean	-0.56 (0.07)	-0.50 (0.08)
Change at Month 6 - unadjusted mean	-0.66 (0.07)	-0.68 (0.08)

4. Secondary Outcome

Title	European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6
Description	EQ-5D-3L is a standardized, participant-administered measure of self-reported health outcomes. It consists of two parts: EQ-5D index score (Part I) and the EQ-VAS (Part II). For Part I, i.e. EQ-5D-3L index score, participants rated their current health state on 5 single-item dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with each dimension having three levels of measure: 1= no problems, 2= some problems and 3= extreme problems. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total index score range of 0 to 1.00; higher scores indicating a better health state. Data has been provided in terms of adjusted (consider impact of co-variables) and unadjusted mean (does not consider co-variables impact).
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

Analysis was performed on participants included in the study. Hence, 'Overall number of participants analyzed' = only those participants who had data available for this OM.

Arm/Group Title	Tofacitinib	Biologics
Arm/Group Description	Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were interruption of treatment and time to supply.	Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variable considered for adjusted mean was public access.
Measure Participants	90	68
Adjusted mean	0.54 (0.05)	0.67 (0.04)
Unadjusted mean	0.63 (0.03)	0.65 (0.04)

5. Secondary Outcome

Title	Change From Baseline in European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6
Description	EQ-5D-3L is a standardized, participant-administered measure of self-reported health outcomes. It consists of two parts: EQ-5D index score (Part I) and the EQ-VAS (Part II). For Part I, i.e. EQ-5D-3L index score, participants rated their current health state on 5 single-item dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with each dimension having three levels of function:. 1=no problems, 2=some problems and 3=extreme problems. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total index score range of 0 to 1.00; higher scores indicating a better health state. Data has been provided in terms of adjusted (consider impact of co-variables) and unadjusted mean (does not consider co-variables impact).
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Analysis was performed on all participants included in the study. Here, 'Number analyzed' = participants evaluable for this OM at specified time points.

Arm/Group Title	Tofacitinib	Biologics
Arm/Group Description	Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were access limitation and interruption of treatment.	Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were access limitation and interruption of treatment.
Measure Participants	100	70
Baseline - adjusted mean	0.19 (0.05)	0.23 (0.04)
Baseline - unadjusted mean	0.30 (0.03)	0.22 (0.04)
Change at Month 6 - adjusted mean	0.23 (0.06)	0.29 (0.06)
Change at Month 6 - unadjusted mean	0.35 (0.04)	0.43 (0.05)

6. Secondary Outcome

Title	Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Description	WPAI-RA: 6-questions participant rated questionnaire that measures effect of participant's RA on general health and symptom severity on work productivity and regular activities. Consisted of 6 questions, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affected productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). It yielded four sub-scores: percent work time missed due to health (absenteeism), percent impairment while working (presenteeism), percent overall work impairment due to health (work productivity loss) and percent activity impairment due to health (daily activity impairment/loss). Sub-scores were expressed as an impairment percentage range from 0 to 100, where 0 = no impairment, 100 = completely impaired, higher scores=greater impairment and less productivity. Data has been provided in terms of adjusted and unadjusted mean.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

Analysis was performed on participants included in the study. Here, 'Overall number of participants analyzed' = only those participants who had data available for this OM. 'Number analyzed' = participants evaluable for this OM at specified categories.

Arm/Group Title	Tofacitinib	Biologics
Arm/Group Description	Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were participant access, years since diagnosis, age, chloroquine concomitant, interruption of treatment, time to supply, access limitation, neutrophils, start treatment, methotrexate concomitant and chloroquine concomitant.	Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were access limitation, years since diagnosis, leflunomide, chloroquine, chloroquine concomitant and public access.
Measure Participants	90	68
Absenteeism: adjusted mean	12.3 (8.83)	10.8 (6.74)
Absenteeism: unadjusted mean	8.78 (6.95)	10.8 (6.74)
Presenteeism: adjusted mean	32.10 (8.82)	27.7 (6.33)
Presenteeism: unadjusted mean	23.30 (5.76)	27.7 (6.33)
Productivity loss: adjusted mean	37.8 (10.25)	26.9 (6.67)
Productivity loss: unadjusted mean	29.3 (6.67)	26.9 (6.67)
Activity loss: adjusted mean	42.7 (4.34)	31.0 (4.79)
Activity loss: unadjusted mean	35.7 (2.75)	27.1 (3.01)

7. Secondary Outcome

Title	Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
Description	WPAI-RA: 6-questions participant rated questionnaire that measures effect of participant's RA on general health and symptom severity on work productivity and regular activities. Consisted of 6 questions, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affected productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). It yielded four sub-scores: percent work time missed due to health (absenteeism), percent impairment while working (presenteeism), percent overall work impairment due to health (work productivity loss) and percent activity impairment due to health (daily activity impairment/loss). Sub-scores were expressed as an impairment percentage range from 0 to 100, where 0 = no impairment, 100 = completely impaired, higher numbers=greater impairment and less productivity. Data has been provided in terms of adjusted and unadjusted mean.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Analysis was performed on participants included in the study. Here, 'Overall number of participants analyzed' = only those participants who had data available for this OM. 'Number analyzed' = participants evaluable for this OM at specified categories.

Arm/Group Title	Tofacitinib	Biologics
Arm/Group Description	Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.	Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
Measure Participants	99	70
Absenteeism: Baseline - adjusted	35.20 (8.59)	36.10 (5.98)
Absenteeism: Baseline - unadjusted	31.49 (6.41)	36.10 (5.98)
Absenteeism: Change at Month 6- adjusted	-18.4 (7.74)	-19.4 (7.99)
Absenteeism: Change at Month 6- unadjusted	-22.4 (7.02)	-24.2 (7.02)
Presenteeism: Baseline - adjusted	66.7 (8.35)	59.2 (5.82)
Presenteeism: Baseline - unadjusted	56.4 (5.33)	59.2 (5.82)
Presenteeism: Change at Month 6- adjusted	-34.8 (5.89)	-34.8 (6.16)
Presenteeism: Change at Month 6- unadjusted	-34.8 (5.89)	-34.8 (6.16)
Productivity loss: Baseline - adjusted	71.1 (9.69)	65.1 (5.98)
Productivity loss: Baseline - unadjusted	62.8 (6.15)	65.1 (5.98)
Productivity loss: Change at Month 6- adjusted	-11.0 (16.5)	-15.9 (15.2)
Productivity loss: Change at Month 6- unadjusted	-36.9 (6.47)	-39.2 (6.79)
Activity loss: Baseline - adjusted	78.0 (4.43)	70.1 (4.79)
Activity loss: Baseline - unadjusted	67.1 (2.64)	66.2 (3.01)
Activity loss: Change at Month 6- adjusted	-43.80 (11.00)	-49.90 (13.30)
Activity loss: Change at Month 6- unadjusted	-32.80 (3.18)	-38.40 (3.66)

8. Secondary Outcome

Title	Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
Description	DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, erythrocyte sedimentation rate (ESR) (measured in millimeters per hour [mm/hour]) and patient's global assessment of disease activity according to 100-millimeter (mm) Visual Analog Scale (VAS) (scores ranging 0 [very well] to 100 mm [extremely bad], higher scores=worsening of condition). DAS28-ESR scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 scores ranged from 0 to 10; higher scores indicated greater affectation due to disease activity. Data has been provided in terms of adjusted and unadjusted mean.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

Analysis was performed on participants included in the study. Here, 'Overall number of participants analyzed' = only those participants who had data available for this OM.

Arm/Group Title	Tofacitinib	Biologics
Arm/Group Description	Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were interruption of treatment, time to supply, access limitation, lymphocytes, neutrophils, swollen joints and corticoids concomitant.	Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months. The co-variables considered for adjusted mean were time to supply, sensitive joints and public access.
Measure Participants	86	61
Adjusted Mean	3.02 (0.24)	2.61 (0.12)
Unadjusted Mean	3.10 (0.13)	2.88 (0.43)

9. Secondary Outcome

Title	Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
Description	DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, erythrocyte sedimentation rate (ESR) (measured in millimeters per hour [mm/hour]) and patient's global assessment of disease activity according to 100-millimeter (mm) Visual Analog Scale (VAS) (scores ranging 0 [very well] to 100 mm [extremely bad], higher scores=worsening of condition). DAS28-ESR scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 scores ranged from 0 to 10; higher scores indicated greater affectation due to disease activity. Data has been provided in terms of adjusted and unadjusted mean.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Analysis was performed on all participants included in the study. Here, 'Number analyzed' = participants evaluable for this OM at specified time points.

Arm/Group Title	Tofacitinib	Biologics
Arm/Group Description	Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.	Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
Measure Participants	100	70
Baseline - adjusted mean	5.59 (0.22)	5.21 (0.11)
Baseline - unadjusted mean	5.21 (0.12)	5.88 (0.40)
Change at Month 6 - adjusted mean	-3.86 (0.59)	-4.23 (0.61)
Change at Month 6 - unadjusted mean	-2.13 (0.35)	-3.03 (0.42)

10. Secondary Outcome

Title	Number of Participants With Serious Adverse Event (SAE) and Non-serious Adverse Events (AEs)
Description	Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included both serious and non-serious adverse event. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Baseline up to Month 6

Outcome Measure Data

Analysis Population Description

Analysis was performed on all participants included in the study.

Arm/Group Title	Tofacitinib	Biologics
Arm/Group Description	Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.	Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
Measure Participants	100	70
Participants with SAE	1 1%	0 0%
Participants with Non-Serious AE	20 20%	16 22.9%

11. Secondary Outcome

Title	Number of Participants With Serious Infections
Description	Serious infection defined as any infection that requires hospitalization.
Time Frame	Baseline up to Month 6

Outcome Measure Data

Analysis Population Description

Analysis was performed on all participants included in the study.

Arm/Group Title	Tofacitinib	Biologics
Arm/Group Description	Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.	Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
Measure Participants	100	70
Count of Participants [Participants]	1 1%	0 0%

12. Secondary Outcome

Title	Number of Participants Who Withdrew From Study Due to Adverse Events And Due to All Causes
Description	Here, number of participants who withdrew from study due to AEs and due to all causes (withdrawals due to AEs, lost to follow up and unspecified reasons) have been described.
Time Frame	Baseline up to Month 6

Outcome Measure Data

Analysis Population Description

Analysis was performed on all participants included in the study.

Arm/Group Title	Tofacitinib	Biologics
Arm/Group Description	Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.	Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
Measure Participants	100	70
Due to AEs	0 0%	1 1.4%
Due to All causes	10 10%	2 2.9%

Adverse Events

Time Frame	Baseline up to Month 6
Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
Arm/Group Title	Tofacitinib		Biologics
Arm/Group Description	Participants with RA treated with tofacitinib after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.		Participants with RA treated with biological DMARDs after failure of conventional DMARDs were assessed for patient-reported outcomes in this study. Data for these participants was collected for approximately 2.5 years (from 15 March 2017 to 16 September 2019) and participants were followed up to 6 months.
All Cause Mortality
	Tofacitinib		Biologics
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/70 (0%)
Serious Adverse Events
	Tofacitinib		Biologics
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/100 (1%)		0/70 (0%)
Gastrointestinal disorders
Appendicitis	1/100 (1%)		0/70 (0%)
Peritonitis	1/100 (1%)		0/70 (0%)
Other (Not Including Serious) Adverse Events
	Tofacitinib		Biologics
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/100 (20%)		16/70 (22.9%)
Blood and lymphatic system disorders
Bicytopenia	1/100 (1%)		0/70 (0%)
Neutropenia	0/100 (0%)		1/70 (1.4%)
Purpura	1/100 (1%)		0/70 (0%)
Endocrine disorders
Oligomenorrhea	1/100 (1%)		0/70 (0%)
Eye disorders
Photophobia	1/100 (1%)		0/70 (0%)
Vision blurred	1/100 (1%)		0/70 (0%)
Gastrointestinal disorders
Abdominal pain	0/100 (0%)		1/70 (1.4%)
Diarrhea	1/100 (1%)		3/70 (4.3%)
General disorders
Malaise	1/100 (1%)		0/70 (0%)
Infections and infestations
Herpes simplex	1/100 (1%)		0/70 (0%)
Herpes zoster	1/100 (1%)		0/70 (0%)
Injury, poisoning and procedural complications
Fall	0/100 (0%)		2/70 (2.9%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/100 (1%)		0/70 (0%)
Coccydynia	0/100 (0%)		1/70 (1.4%)
Lumbar vertebral fracture	1/100 (1%)		0/70 (0%)
Musculoskeletal pain	0/100 (0%)		1/70 (1.4%)
Myalgia	1/100 (1%)		0/70 (0%)
Nervous system disorders
Headache	3/100 (3%)		2/70 (2.9%)
Spinal pain	1/100 (1%)		0/70 (0%)
Renal and urinary disorders
Cystitis	1/100 (1%)		0/70 (0%)
Pollakiuria	1/100 (1%)		0/70 (0%)
Urinary tract infection	1/100 (1%)		2/70 (2.9%)
Reproductive system and breast disorders
Vulvovaginitis	1/100 (1%)		0/70 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/100 (1%)		0/70 (0%)
Influenza	3/100 (3%)		1/70 (1.4%)
Nasopharyngitis	0/100 (0%)		2/70 (2.9%)
Pharyngitis	1/100 (1%)		3/70 (4.3%)
Pharyngitis bacterial	1/100 (1%)		0/70 (0%)
Pharyngotonsillitis	2/100 (2%)		0/70 (0%)
Rhinorrhea	0/100 (0%)		1/70 (1.4%)
Skin and subcutaneous tissue disorders
Alopecia	1/100 (1%)		0/70 (0%)
Ecchymosis	1/100 (1%)		0/70 (0%)

Limitations/Caveats

DAS 28 data for month 3 was not collected and analyzed since data was planned to be collected depending on the availability of medical records as specified in analysis.

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.