The FDA has approved tofacitinib (Xeljanz®/Xeljanz® XR) 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).
Tofacitinib is the first and only Janus kinase (JAK) inhibitor approved by the FDA for both moderate to severe rheumatoid arthritis (RA) and active PsA, according to Pfizer, which made the announcement in a press release.
The recommended dose of tofacitinib 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 of tofacitinib for the treatment of adult patients with active PsA was based on data 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 and were reported by Rheumatology Network.
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 3 months in patients receiving Xeljanz 5 mg BID treatment in combination with a nonbiologic DMARD, compared with those treated with placebo.
In OPAL Broaden, 50% of patients taking Xeljanz 5 mg BID achieved an ACR20 response, compared with 33% of patients taking placebo (P ≤ .05), at 3 months. In OPAL Beyond, 50% of patients achieved an ACR20 response with Xeljanz 5 mg BID, compared with 24% of patients taking placebo (P ≤ .05), at 3 months.
In both studies, statistically significant improvements in ACR20 response were also seen with Xeljanz 5 mg BID compared with placebo at week 2, a secondary endpoint and the first post-baseline assessment (OPAL Broaden: 22% and 6% [P = .0003], respectively; OPAL Beyond: 27% and 13% [P = .0046], respectively).
“As a practicing rheumatologist, I’ve seen the significant physical impact psoriatic arthritis has on people living with the disease, and many patients are looking for additional therapeutic options,” said Philip Mease, MD, Swedish Medical Center, University of Washington and study investigator. “I’m pleased that Xeljanz is now available for use in the treatment of this chronic condition.”
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 XELJANZ 5 mg BID were nasopharyngitis, upper respiratory tract infection, headache and diarrhea.