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

Abstract

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.

Keywords: Anti-rheumatic agents; Arthritis; Psoriatic.

Conflict of interest statement

DDG has received research grants from AbbVie, Amgen, Celgene, Eli Lilly, Novartis, Pfizer Inc, and UCB, and has been a consultant for AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Galapagos, Gilead, Eli Lilly, Janssen, Novartis, Pfizer Inc, and UCB. LCC has received research grants from AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Novartis, Pfizer Inc, and UCB, has acted as a consultant for AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer Inc, and UCB, and has received honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, GSK, Janssen, Lilly, Medac, Novartis, Pfizer Inc, and UCB. JW, LF, JCC, and AGB are employees and stockholders of Pfizer Inc. EDB has received consulting fees from Pfizer Inc. PSH has received research grants from AbbVie, Janssen, and Novartis, and has received honoraria from AbbVie, Amgen, Celgene, Galapagos, Pfizer Inc, and UCB.

© 2022. The Author(s).

Figures

Fig. 1

Time to initial HAQ-DI score response: a OPAL Broaden, b OPAL Beyond (FAS). Score response defined for HAQ-DI as ≥ 0.35-point improvement from baseline (analyzed for patients with baseline HAQ-DI ≥ 0.35). BID, twice daily; FAS, full analysis set; HAQ-DI, Health Assessment Questionnaire-Disability Index; Q2W, once every 2 weeks; SC, subcutaneous

Fig. 2

Time to initial FACIT-F total score response: a OPAL Broaden, b OPAL Beyond (FAS). Response defined for FACIT-F total score as ≥ 4-point improvement from baseline. BID, twice daily; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; FAS, full analysis set; Q2W, once every 2 weeks; SC, subcutaneous

Fig. 3

Time to initial MDA response: a OPAL Broaden, b OPAL Beyond (FAS). Response defined for MDA as meeting ≥ 5 of 7 of the following disease activity outcome criteria: tender joint count ≤ 1; swollen joint count ≤ 1; Psoriasis Area and Severity Index score ≤ 1 or body surface area ≤ 3%; Patient’s Assessment of Arthritis Pain VAS ≤ 15 mm; Patient’s Global Assessment of Arthritis VAS ≤ 20 mm; Health Assessment Questionnaire-Disability Index score ≤ 0.5; or tender entheseal points (using the Leeds Enthesitis Index) ≤ 1 [23]. BID, twice daily; FAS, full analysis set; MDA, minimal disease activity; Q2W, once every 2 weeks; SC, subcutaneous; VAS, visual analog scale

Fig. 4

Time to initial PASDAS response: a OPAL Broaden, b OPAL Beyond (FAS). Response defined for PASDAS as post-baseline score of ≤ 3.2 and > 1.6-point improvement from baseline (analyzed for patients with baseline PASDAS > 3.2). BID, twice daily; FAS, full analysis set; PASDAS, Psoriatic Arthritis Disease Activity Score; Q2W, once every 2 weeks; SC, subcutaneous