An Investigation of Tofacitinib PsA Initiators in the CorEvitas SpA Registry
Study Details
Study Description
Brief Summary
Given the limited data available on the real-world effectiveness of tofacitinib in patients with PsA, the purpose of this study is to provide a characterization of patients and effectiveness of tofacitinib in PsA patients newly initiating tofacitinib in the US CorEvitas PsA/spondyloarthritis (SpA) Registry.
It should be noted that while this observational study retrospectively assesses patients currently enrolled in the CorEvitas PsA/SpA Registry, it is not, nor will it ever, actively recruit patients. To enroll and participate in the CorEvitas PsA/SpA Registry, please refer to the following study, NCT02530268 and contact the Sponsor, CorEvitas LLC.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Tofacitinib is an oral Janus kinase (JAK) inhibitor approved in 2017 by the US Food and Drug Administration (FDA) for the treatment of adult patients with active PsA who have had an inadequate response or intolerance to methotrexate or other disease modifying antirheumatic drugs (DMARDs). As of December 3, 2021, Tofacitinib is approved for use in patients who have had an inadequate response or intolerance to one or more TNF blockers.
This is an observational retrospective cohort study that will be conducted using patients enrolled in the CorEvitas PsA/SpA Registry, initiating tofacitinib on or after December 14th, 2017. Patients receiving tofacitinib will be included to assess the effectiveness of tofacitinib overall and when stratified by key variables of interest. More specifically, the overall aim will be to describe baseline demographic, therapy history, and disease activity characteristics and assess change in disease activity measures six months after initiation of tofacitinib.
There are two primary objectives for this study:
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To describe the effectiveness of all tofacitinib initiators at 6 months in PsA patients
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To describe the effectiveness of all tofacitinib initiators at 6 months stratified by monotherapy and combination therapy, line of therapy, and specific manifestations of PsA
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Effectiveness of tofacitinib Participants receiving tofacitinib will be included to assess the effectiveness of tofacitinib overall and stratified by key variables of interest |
Outcome Measures
Primary Outcome Measures
- Change from baseline in number of patients achieving low disease activity as defined by the clinical Disease Activity index for Psoriatic Arthritis (cDAPSA) score [Baseline, Month 6]
The clinical disease activity index for Psoriatic Arthritis (cDAPSA) is a composite score that includes swollen and tender joints (66/68), Patient Global assessment of disease activity (PtGA VAS), and Patient assessment of Pain (Pt Pain VAS). Low disease activity is a cDAPSA score <4
- Change from baseline in number of patients achieving Minimal Disease Activity [Baseline, Month 6]
A psoriatic arthritis patient is defined as having Minimal Disease Activity (MDA)26 when the patient meets at least 5 of the 7 following criteria: 1) tender joint count at least 1; 2) swollen joint count at least 1; 3) PASI score at least 1 or BSA; 4) patient Arthritis Pain (VAS) 15; 5) patient's global arthritis assessment (VAS) 20; HAQ-DI score 0.5; 6) tender entheseal points (using Leed's Index)
- Change from baseline in number of patients achieving a Body Surface Area (BSA) score of 0 [Baseline, Month 6]
Body Surface Area (BSA) is scored as the percentage body area affected by psoriasis; 0-100%
- Change from Baseline in clinical Disease Activity index for Psoriatic Arthritis (cDAPSA) score [Baseline, Month 6]
The clinical disease activity index for Psoriatic Arthritis (cDAPSA) is a composite score that includes swollen and tender joints (66/68), Patient Global assessment of disease activity (PtGA VAS), and Patient assessment of Pain VAS).
- Change from Baseline in Disease Activity index for Psoriatic Arthritis (DAPSA) score [Baseline, Month 6]
The clinical disease activity index for Psoriatic Arthritis (cDAPSA) is a composite score that includes swollen and tender joints (66/68), Patient Global assessment of disease activity (PtGA VAS), and Patient assessment of Pain VAS).
- Change from Baseline in Psoriatic Arthritis Disease Activity (PASDAS) score [Baseline, Month 6]
The Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite PsA disease activity score that includes: patient global psoriatic arthritis assessment (VAS), physician global psoriatic arthritis assessment (VAS), swollen and tender joint counts (66/68), Leed's Enthesitis Index score, tender dactylitic digit score, physical component summary score (PCS) of the SF-36 and CRP
- Change from Baseline in Health Assessment Questionnaire-Disability index (HAQ-DI) score [Baseline, Month 6]
The Health Assessment Questionnaire-Disability Index (HAQ-DI) assesses the degree of difficulty a subject has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status
- Change from Baseline in Body Surface Area (BSA) [Baseline, Month 6]
Body Surface Area (BSA) is scored as the percentage body area affected by psoriasis; 0-100%
- Change from Baseline in Clinical Disease Activity index (CDAI) score [Baseline, Month 6]
CDAI is the numerical sum of 4 outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 to 10 cm VAS; CDAI total score = 0 to 76, higher scores=greater affection due to disease activity. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
- Change from Baseline in patient's global skin assessment score (VAS) [Baseline, Month 6]
Patient self-reported assessment of their disease using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (excellent) and 100 (poor). The rating corresponds to the way in which the subject felt over the past week in terms of how they were affected by their psoriasis only
- Change from Baseline in patient's global assessment of pain score (VAS) [Baseline, Month 6]
Patient self-reported assessment of the severity of their arthritis pain using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain
- Change from Baseline in patient's global assessment of fatigue score (VAS) [Baseline, Month 6]
Patient self-reported assessment of the severity of their arthritis fatigue using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no fatigue) and 100 (most severe fatigue), which corresponds to the magnitude of their fatigue
Eligibility Criteria
Criteria
Inclusion Criteria:
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PsA patients in CorEvitas initiating tofacitinib monotherapy or in combination with oral small molecules (eg methotrexate, leflunomide, sulfasalazine, apremilast) after 14 December 2017 (market approval of tofacitinib in the US) with no prior use of tofacitinib. Only the patient's first initiation after December 14, 2017 will be included in the analysis
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Have a 6 month follow-up visit (with ±3 month window)
Exclusion Criteria:
- Patients taking tofacitinib in combination with any other bDMARD
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer | New York | New York | United States | 10017 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A3921411