Xeljanz Achieves Positive Results in Phase 3 Psoriatic Arthritis Trial
Tofacitinib citrate (Xeljanz) treats adults with active psoriatic arthritis.
Positive top-line results were achieved in a second phase 3 trial of tofacitinib citrate (Xeljanz) in the treatment of adults with active psoriatic arthritis (PsA).
The Oral Psoriatic Arthritis triaL (OPAL) Beyond is a double-blind, placebo-controlled, randomized, phase 3 study that is the second in the OPAL developmental program. The goal of the study was to test the safety and efficacy of the oral Janus kinase (JAK) inhibitor drug Xeljanz.
Researchers randomized 395 adults with active PsA who had inadequate responses to at least 1 tumor necrosis factor inhibitor (TNFi) to receive 5 mg BID of Xeljanz, 10 mg BID of Xeljanz, or placebo. Participants eligible for the study were required to be on 1 conventional synthetic disease modifying antirheumatic drug (csDMARD) as background therapy that they would continue throughout the study.
The primary efficacy endpoints were met in the study, demonstrating a statistically significant result (p<0.0001) in PsA patients with tofacitinib 5 mg BID and 10 mg BID compared with placebo.
The endpoints were measured by the American College of Rheumatology 20 (ACR20) response and Health Assessment Questionnaire Disability Index (HAQ-DI) score at 3 months.
The overall safety findings were found to be consistent with those seen in the broader rheumatology clinical development program for Xeljanz.
“There is a significant need for additional PsA treatment options as many people living with the condition do not respond well to available therapies,” said Michael Corbo, Category Development Lead, Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business. “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.”