FDA: New Option for Psoriatic Arthritis Approved

The FDA has approved Xeljanz 5 mg twice daily and Xeljanz XR (tofacitinib) extended release 11 mg once daily for the treatment of adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).

The approval was based upon the results of a Phase 3 clinical development program consisting of 2 studies which both met their primary efficacy endpoints, demonstrating significant improvements in ACR20 response and change from baseline at 3 months.
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The most common adverse events were nasopharyngitis, upper respiratory tract infection, headache, and diarrhea.

—Michael Potts

Reference:

Pfizer announces FDA approval of XELJANZ® (tofacitinib) and XELJANZ® XR for the treatment of active psoriatic arthritis [press release]. December 14, 2017. https://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_fda_approval_of_xeljanz_tofacitinib_and_xeljanz_xr_for_the_treatment_of_active_psoriatic_arthritis.