FDA Officials OK Tofacitinib for Active Psoriatic Arthritis

DECEMBER 15, 2017
Officials with Pfizer Inc. have announced that the FDA has approved tofacitinib (Xeljanz 5 mg twice daily (BID) and the extended release 11 mg once daily (QD) formulation the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).

The recommended dose of Xeljanz/Xeljanz XR is in combination with nonbiologic DMARDs, and use in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

The FDA approval was based on data from the phase 3 Oral Psoriatic Arthritis Trial (OPAL) clinical development program, which consisted of 2 studies, OPAL Broaden and OPAL Beyond, as well as available data from an ongoing long-term extension trial, OPAL Balance, which both met their two primary efficacy endpoints, demonstrating statistically significant improvements in American College of Rheumatology 20 (ACR20) response and change from baseline in the Health Assessment Questionnaire–Disability Index (HAQ-DI) score at 3 months in patients receiving XELJANZ 5 mg BID treatment in combination with a nonbiologic DMARD, compared to those treated with placebo. 

The safety profile observed in patients with active psoriatic arthritis treated with Xeljanz was consistent with the safety profile observed in rheumatoid arthritis patients. The most common adverse events observed occurring in greater than 3% of patients on were nasopharyngitis, upper respiratory tract infection, headache and diarrhea. 

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