The Food and Drug Administration has approved tofacitinib and an extended-release formulation of the drug for adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs), according to a Dec. 14 announcement from its manufacturer, Pfizer.
The approvals of tofacitinib (Xeljanz) at 5 mg twice daily and extended-release tofacitinib (Xeljanz XR) at 11 mg once daily are 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 .
In the OPAL Broaden study, 50% of patients who received tofacitinib 5 mg twice daily in combination with a nonbiologic DMARD achieved an ACR20 response at 3 months, compared with 33% of those treated with placebo (P equal to or less than .05). In the OPAL Beyond study, 50% of patients achieved an ACR20 response with tofacitinib 5 mg twice daily at 3 months, when compared with 24% of patients taking placebo (P equal to or less than .05).
In both studies, significant improvements in ACR20 response was also seen with tofacitinib 5 mg twice daily when compared with placebo at week 2, which was a secondary endpoint and the first post-baseline assessment (OPAL Broaden: 22% vs. 6% [P = .0003]; OPAL Beyond: 27% vs. 13% [P = .0046]).
Tofacitinib is the first and only Janus kinase inhibitor approved by the FDA to treat both moderate to severe rheumatoid arthritis and active PsA, Pfizer said in its announcement . It is noted that 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 safety of tofacitinib in these trials was consistent with the safety profile observed in rheumatoid arthritis patients. The most common adverse events that occurred in greater than 3% of patients on tofacitinib 5 mg twice daily were nasopharyngitis, upper respiratory tract infection, headache, and diarrhea.