Investigational Psoriatic Arthritis Drug Shows Promise in Phase 3 Trial
The oral Janus kinase inhibitor tofacitinib treats adults with active psoriatic arthritis (PsA).
Pfizer recently announced top-line results from the first phase 3 clinical trial evaluating the safety and efficacy of the investigational oral Janus kinase inhibitor tofacitinib in adults with active psoriatic arthritis (PsA).
The randomized, double-blind, placebo-controlled, phase 3 study Oral Psoriatic Arthritis triaL (OPAL) Broaden met its primary endpoints for treating adults with active PsA who had an inadequate response to at least 1 conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) and were tumor necrosis factor inhibitor (TNFi)-naïve.
During the study, 422 patients were randomized in a 2:2:2:1:1 to receive either tofacitinib 5 mg BID, tofacitinib 10 mg BID, adalimumab 40 mg every 2 weeks, placebo to tofacitinib 5 mg BID, and placebo to tofacitinib 10 mg BID treatment sequences.
Participants were required be on 1 csDMARD as background therapy and continue the dose for the duration of the study.
The results showed that over 12 months, the groups had similar rates of treatment-emergent adverse events, serious adverse events, and discontinuations because of adverse events.
Serious adverse events were found to be similar to those in other tofacitinib clinical development programs.
The primary endpoints met during the study as measured by American College of Rheumatology 20 (ACR20) response and Health Assessment Questionnaire Disability Index (HAQ-DI) score showed that tofacitinib 5 mg BID and 10 mg BID were superior to treatment with placebo at 3 months.
“As a chronic inflammatory disease, psoriatic arthritis can have a significant impact on a person’s daily life,” said Michael Corbo, category development lead, Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business. “Despite available therapies, including biologic and oral treatments, there remains an unmet need for additional options. The results seen in the OPAL Broaden study are encouraging as they suggest that tofacitinib may have the potential to offer an additional effective oral option for patients living with psoriatic arthritis. We look forward to sharing detailed results at a future scientific meeting.”