Reference: June 2025 | Issue 6 | Vol 11 | Page 13
There are limited data on outcomes when switching treatment directly from tumour necrosis factor inhibitor (TNFi) to tofacitinib in psoriatic arthritis (PsA).
Researchers from a collaboration of international research institutions, including the Conway Institute for Biomolecular Research at University College Dublin, conducted a post-hoc analysis of data from the phase 3 OPAL Broaden and the long-term extension (LTE) OPAL Balance studies to assess efficacy and safety outcomes in patients with PsA who switched to tofacitinib after adalimumab, compared with those who continued to receive tofacitinib.
Patients with active PsA received tofacitinib 5mg twice daily or adalimumab 40mg once every two weeks in the 12-month, randomised, double-blind study (OPAL Broaden) and then continued or switched to tofacitinib 5mg twice daily and maintained this dose in an open-label LTE study (OPAL Balance).
Efficacy was assessed three months before the last visit and at the last visit in the phase 3 study, and at month three or six in the LTE study, and included rates of ≥20/50/70 per cent improvement in American College of Rheumatology (AMR) response criteria, Psoriasis Area and Severity Index (PASI) ≥75 per cent improvement, Health Assessment Questionnaire-Disability Index (HAQ-DI) response (decrease from baseline ≥0.35), Psoriatic Arthritis Disease Activity Score (PADAS) ≤3.2, and minimal disease activity; and a change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue score. Safety was assessed at months three and 12 in both studies.
A total of 180 participants were included in the post-hoc analysis. Efficacy was similar between groups in the phase 3 study, and was maintained to month three or six in the LTE study. Treatment-emergent adverse events (AEs), serious AEs, and serious infections were generally similar in both studies, and between groups within each study.
The findings demonstrate that the efficacy and safety of tofacitinib is similar in patients with PsA who directly switch from adalimumab to tofacitinib and those who continued tofacitinib, suggesting that patients can be directly switched from adalimumab to tofacitinib without any washout period.
Reference
Gladman DD, Nash P, Mease PJ, FitzGerald O, Duench S, Cadatal MJ, Masri KR. Efficacy and safety of tofacitinib in an open-label, long-term extension study in patients with psoriatic arthritis who received adalimumab or tofacitinib in a phase 3 randomised, controlled study: A post hoc analysis. Arthritis Res Ther. 2024 Dec 19;26(1):218. doi: 10.1186/s13075-024-03442-2. PMID: 39702318; PMCID: PMC11657006.
