Journal Article

Time to response for clinical and patient-reported outcomes in patients with psoriatic arthritis treated with tofacitinib, adalimumab, or placebo

Helliwell, Philip S., Bushmakin, Andrew G., Fallon, Lara, Coates, Laura C., Cappelleri, Joseph C., Gladman, Dafna D., Bacci, Elizabeth D., Wu, Joseph

2022

Overview

Background This study examined the time to clinically meaningful response in patients with active psoriatic arthritis treated with tofacitinib, adalimumab, or placebo switching to tofacitinib. Methods Data were from two phase 3 studies, OPAL Broaden (12 months) and OPAL Beyond (6 months). Patients received tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks (OPAL Broaden only), or placebo switching to tofacitinib 5 or 10 mg BID at month 3. Baseline to initial response time was according to pre-defined clinically meaningful criteria on Health Assessment Questionnaire-Disability Index (HAQ-DI; ≥ 0.35-point improvement), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F; ≥ 4-point improvement), Psoriatic Arthritis Disease Activity Score (PASDAS; post-baseline score ≤ 3.2 and > 1.6-point improvement from baseline), and minimal disease activity (MDA; meeting at least 5 of 7 criteria) composite. Results In OPAL Broaden, median time to initial HAQ-DI score response was 29, 53, and 30 days in patients treated with tofacitinib 5 mg BID, tofacitinib 10 mg BID, or adalimumab, compared with 162 and 112 days in patients treated with placebo switching to tofacitinib 5 or 10 mg BID at month 3, respectively. Across studies, median time to initial FACIT-F total score response was shorter in patients receiving tofacitinib 5 mg BID (31 days) vs other groups (84–92 days). Median time to initial response was approximately 11 (MDA)/6–9 months (PASDAS) in tofacitinib/adalimumab groups in OPAL Broaden. Conclusion This analysis demonstrates tofacitinib’s efficacy on most patient-reported and clinical endpoints over time and shows a shorter time to initial, clinically meaningful response in patients receiving tofacitinib vs patients switching from placebo to tofacitinib. Trial registration ClinicalTrials.gov , NCT01877668. Registered June 12, 2013. ClinicalTrials.gov , NCT01882439. Registered June 18, 2013.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adalimumab / Anti-rheumatic agents / Antirheumatic Agents / Arthritis / Arthritis, Psoriatic - drug therapy / Chronic illnesses / Diagnosis / Dosage and administration / Drug therapy / Humans / Medicine / Medicine & Public Health / Monoclonal antibodies / Orthopedics / Pain / Patient outcomes / Patient Reported Outcome Measures / Patients / Piperidines / Psoriatic / Psoriatic arthritis / Pyrimidines / Pyrroles / Questionnaires / Research Article / Rheumatology / TNF inhibitors / Tofacitinib / Treatment Outcome