November 15, 2016
Pfizer Inc. has announced that new results from the Phase 3 Oral Psoriatic Arthritis TriaL(OPAL) studies, Broaden and Beyond, will be presented at the ACR/ARHP Annual Meeting 2016, which will be held in November 11-16, in Washington, DC. OPAL Broaden and OPAL Beyond evaluated the safety and efficacy of XELJANZ® (tofacitinib citrate) in adult patients with active psoriatic arthritis (PsA). These patients had an inadequate response (IR) to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or to tumor necrosis factor inhibitors (TNFis), respectively. OPAL Broaden and OPAL Beyond met their primary efficacy endpoints that revealed a statistically significant improvement with tofacitinib 5 mg and 10 mg twice daily (BID). Detailed results from OPAL Broaden will be presented during a plenary session for the first time at ACR/ARHP. Additionally, results from OPAL Beyond will be presented during a late-breaking abstract poster session.
Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development, said: “Psoriatic arthritis is a chronic condition that can have a significant and potentially debilitating impact on people with the disease, who currently have limited treatment options. As the only JAK inhibitor being investigated in psoriatic arthritis, tofacitinib, if approved, would provide patients and healthcare professionals the first medicine in a new class to treat this disease. We continue to progress the OPAL clinical development program globally and look forward to possible future regulatory filings.”