April 5, 2016
Pfizer Inc. in U.S. has announced positive results from its first phase 3 study investigation of tofacitinib for treating adult patients with psoriatic arthritis. The Oral Psoriatic Arthritis trial (OPAL) Broaden study evaluated the safety and efficacy of tofacitinib 5 mg and 10 mg twice daily (BID) in adult patients with active psoriatic arthritis (PsA), which is a chronic inflammatory multisystem disease causing skin inflammation, pain and swelling of the joints, inflammation of the spine, fingers, and toes. These patients were tumor necrosis factor inhibitor (TNFi)-naïve and had an inadequate response to at least one conventional synthetic disease-modifying anti-rheumatic drug (csDMARD). Results from the trial OPAL Broaden demonstrated that both tofacitinib 5 mg BID and 10 mg BID were superior to treatment with placebo at 3 months as measured by Health Assessment Questionnaire Disability Index (HAQ-DI) score and American College of Rheumatology 20 (ACR20) response.
Michael Corbo, Category Development Lead, Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business, said: “As a chronic inflammatory disease, psoriatic arthritis can have a significant impact on a person’s daily life. 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.”
This OPAL Broaden is a phase 3 placebo-controlled study for investigating the safety and effectiveness of tofacitinib 5 mg and 10 mg BID for treating the signs and symptoms of PsA, and also for improving the conditions of patients with active PsA who have an inadequate response to at least one csDMARD due to lack of adverse event or efficacy, and who are TNFi-naive. Enrolled patients were needed to be on one csDMARD as background therapy and continue that dose for the entire duration of the study. As an active control arm, this study also included adalimumab 40 mg internally administered every 2 weeks, although this study was not intended to compare the efficacy of adalimumab and tofacitinib. In total, 222 patients were given the following treatment arms in a 2:2:2:1:1 ratio: tofacitinib 5 mg BID, tofacitinib 10 mg BID, adalimumab 40 mg q2 wk, placebo to tofacitinib 5 mg BID and placebo to tofacitinib 10 mg BID treatment sequences. It was also observed in this study that the overall safety findings were consistent with those observed in the broader rheumatology clinical development program for tofacitinib.