OPAL Broaden and Beyond trials of Xeljanz (tofacitinib citrate) for psoriatic arthritis presented at ACD/ARHP meeting by Pfizer.

Oral Psoriatic Arthritis TriaL (OPAL) studies, Broaden and Beyond, were presented at the 2016 ACR/ARHP Annual Meeting (November 11-16, Washington, DC). OPAL Broaden and OPAL Beyond evaluated the efficacy and safety of Xeljanz (tofacitinib citrate) from Pfizer in adult patients with active psoriatic arthritis (PsA) who 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 showing a statistically significant improvement with tofacitinib 5 mg and 10 mg twice daily (BID) compared to treatment with placebo at three months as measured by American College of Rheumatology 20 (ACR20) response (OPAL Broaden: p?0.05 and p<0.0001; OPAL Beyond: p<0.0001, respectively), and change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score (OPAL Broaden: p?0.05 and p<0.001; OPAL Beyond: p<0.0001 and p<0.001, respectively). OPAL Broaden, which was a 12-month duration trial with a three month placebo-controlled period, evaluated the efficacy and safety of tofacitinib 5 mg (n=107) and 10 mg (n=104) BID compared to placebo (n=105) in adult patients with active PsA who had an IR to at least one csDMARD and who were TNFi-naïve.

OPAL Broaden included an active control arm of adalimumab 40 mg (n=106) administered subcutaneously every two weeks (q2 wk). The study was not designed for non-inferiority or superiority comparisons between adalimumab and tofacitinib. OPAL Beyond, a six-month duration trial with a three month placebo-controlled period, evaluated the efficacy and safety of tofacitinib 5 mg (n=131) and 10 mg (n=132) BID compared to placebo (n=131) in adult patients with active PsA who had an IR to at least one TNFi. OPAL Beyond focused exclusively on the TNFi-IR patient population. In both studies, patients who were initially randomized to placebo advanced to tofacitinib 5 or 10 mg BID in a blinded manner at three months.

Efficacy Results- In OPAL Broaden, 50.5% and 60.6% of patients achieved an ACR20 response with tofacitinib 5 mg and 10 mg BID, respectively, compared to 33.3% of patients taking placebo at three months. Patients taking adalimumab 40 mg q2 wk achieved an ACR20 response rate of 51.9%. In OPAL Beyond, 49.6% and 47.0% of patients achieved ACR20 response with tofacitinib 5 mg and 10 mg BID, respectively, compared to 23.7% of patients taking placebo at three months. In both studies, changes from baseline in HAQ-DI score were statistically significantly greater with tofacitinib 5 mg and 10 mg BID compared to placebo at three months.