The 395-patient study assessed the safety and efficacy of 5 mg and 10 mg of tofacitinib administered twice daily in adult patients with active psoriatic arthritis (PsA) who had an inadequate response to at least one tumor necrosis factor inhibitor (TNFi).
Patients treated with both doses of tofacitinib showed a statistically significant (p<0.0001) improvement in their PsA compared to placebo as measured by ACR20 (20% improvement in symptoms) and HAQ-DI score (health assessment questionnaire).
Pfizer Global Innovative Pharmaceuticals Business category development lead for inflammation & immunology Michael Corbo said: "The positive results of both Phase 3 PsA studies, OPAL Broaden in DMARD-IR patients and OPAL Beyond in TNFi-IR patients, demonstrate that tofacitinib, if approved, may have potential to be an important treatment option to help address unmet needs for patients with PsA."
The study is part of the OPAL global clinical development program, which includes two Phase 3 studies as well as a long-term extension trial.
Pfizer expects the three studies to form the potential submission package for possible future regulatory applications.
In the US, Xeljanz XR 11 mg QD is approved to treat moderate to severe rheumatoid arthritis (RA).
Xeljanz is approved in over 45 countries globally for the treatment of moderate to severe RA as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs.
Image: Xeljanz Bottle Image. Photo: courtesy of Pfizer Inc.