Pfizer announced top-line results from the OPAL Beyond study, the second Phase 3 trial of Xeljanz (tofacitinib citrate) for the potential treatment of patients with active psoriatic arthritis (PsA).

OPAL (Oral Psoriatic Arthritis) Beyond, a randomized, double-blind, placebo-controlled, 6-month trial, is part of the OPAL global clinical development program consisting of two Phase 3 studies and one long-term extension trial. This study evaluated the efficacy and safety of tofacitinib 5mg and 10mg twice daily vs. placebo in 395 adult patients with active PsA who had inadequate or intolerable response to ≥1 tumor necrosis factor inhibitor (TNFi). The primary efficacy endpoint was improvement in symptoms as measured by American College of Rheumatology 20 (ACR20) response and Health Assessment Questionnaire Disability Index (HAQ-DI) score at 3 months. 

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Results from OPAL Beyond showed that treatment with tofacitinib 5mg and 10mg twice daily demonstrated a statistically significant improvement vs. placebo based on ACR20 and HAQ-DI scores at 3 months, meeting the study’s primary endpoint. Overall adverse events rates were consistent with those observed in broader tofacitinib rheumatology studies. Detailed study findings are expected to be submitted for presentation at a future medical meeting.

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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