You are here
Pfizer Inc. announced today that the United States Food and Drug Administration (FDA) has approved Xeljanz (tofacitinibi) for 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).
It is approved at the same dose as rheumatoid arthritis, either 5 mg twice daily or the extended release 11 mg once daily (QD) dose.
Xeljanz may be used in combination with nonbiologic DMARDs, but the label points out that use in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
This new approval is based on from the Phase 3 Oral Psoriatic Arthritis Trial (OPAL) clinical development program, which consisted of two pivotal studies, OPAL Broaden and OPAL Beyond, as well as available data from an ongoing long-term extension trial, OPAL Balance. The findings from OPAL Broaden and OPAL Beyond were published in October 2017 in the New England Journal of Medicine.
Both pivotal studies 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 three months in patients receiving XELJANZ 5 mg BID treatment in combination with a nonbiologic DMARD, compared to those treated with placebo.
In OPAL Broaden, 50% of patients taking XELJANZ 5 mg BID achieved an ACR20 response, compared to 33% of patients taking placebo (p≤0.05), at three months. In OPAL Beyond, 50% of patients achieved an ACR20 response with XELJANZ 5 mg BID, compared to 24% of patients taking placebo (p≤0.05), at three months. In both studies, statistically significant improvements in ACR20 response was also seen with XELJANZ 5 mg BID compared to placebo at week 2, a secondary endpoint and the first post-baseline assessment (OPAL Broaden: 22% and 6% [p=0.0003], respectively; OPAL Beyond: 27% and 13% [p=0.0046], respectively).
The Xeljanz safety profile observed in patients with active psoriatic arthritis was consistent with the safety profile observed in rheumatoid arthritis patients. The most common adverse events observed were nasopharyngitis, upper respiratory tract infection, headache and diarrhea.