Phase III OPAL Beyond study of Xeljanz (tofacitinib citrate) in psoriatic arthritis meets primary endpoint- Pfizer

Pfizer announced top-line results from Oral Psoriatic Arthritis triaL (OPAL) Beyond, the second Phase III study of Xeljanz (tofacitinib citrate) being investigated in patients with active psoriatic arthritis (PsA). This study evaluated the efficacy and safety of tofacitinib 5 mg and 10 mg twice daily (BID) in adult patients with active PsA who had an inadequate response to at least one tumor necrosis factor inhibitor (TNFi), making it the first PsA study to focus exclusively on TNFi-IR patients.

OPAL Beyond met its primary efficacy endpoints demonstrating a statistically significant improvement with tofacitinib 5 mg BID and 10 mg BID compared to placebo treatment as measured by American College of Rheumatology 20 (ACR20) response and Health Assessment Questionnaire Disability Index (HAQ-DI) score at 3 months. Overall safety findings in this study were consistent with those observed in the broader rheumatology clinical development program for tofacitinib.

Comment: The OPAL global clinical development program includes two Phase III studies, OPAL Broaden and OPAL Beyond, as well as a long-term extension trial, OPAL Balance. These three studies are expected to form the potential submission package for possible future regulatory applications. Positive top-line results for OPAL Broaden were announced in April 2016. Detailed results for OPAL Broaden and OPAL Beyond are expected to be submitted for presentation at a future scientific meeting.