Pfizer announced top-line results from its first Phase 3 study, OPAL Broaden, evaluating the efficacy and safety of tofacitinib for the treatment of active psoriatic arthritis (PsA) in adults who had an inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) and who were tumor necrosis factor inhibitor (TNFi)-naïve.
OPAL Broaden is a randomized, placebo-controlled Phase 3 trial evaluating tofacitinib in 422 patients for the treatment of signs and symptoms of PsA and for the improvement in physical function in patients with active PsA. Patients either received tofacitinib 5mg twice daily, tofacitinib 10mg twice daily, adalimumab 40mg SC every 2 weeks (as an active control arm), placebo to tofacitinib 5mg twice daily and placebo to tofacitinib 10mg twice daily. Patients were required to be on one csDMARD as background therapy and continue that dose for the duration of the study.
Results showed that the study met its primary endpoints demonstrating that both tofacitinib 5mg and 10mg twice daily were superior to placebo at 3 months as measured by American College of Rheumatology 20 (ACR20) response and Health Assessment Questionnaire Disability Index (HAQ-DI) score. Detailed results will be presented at a future scientific meeting.
The OPAL (Oral Psoriatic Arthritis trial) global clinical development program for tofacitinib includes two Phase 3 studies, OPAL Broaden and OPAL Beyond, and a long-term extension trial, OPAL Balance. Data from these studies are expected to be used to support possible regulatory applications seeking expansion for the label of Xeljanz (tofacitinib citrate) to include a PsA indication.
Tofacitinib is a Janus kinase (JAK) inhibitor. It is currently available as Xeljanz and Xeljanz XR for the treatment of moderate to severe rheumatoid arthritis (RA) in adults who have had an inadequate response or intolerance to methotrexate (MTX), as monotherapy or in combination with MTX or other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs).
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