FDA OKs Tofacitinib (Xeljanz) for Active Psoriatic Arthritis

Megan Brooks

Disclosures

December 18, 2017

The US Food and Drug Administration (FDA) has approved tofacitinib (Xeljanz/Xeljanz XR, Pfizer) for treatment of adults with active psoriatic arthritis (PsA) who have failed to respond adequately or are intolerant to methotrexate or other disease-modifying antirheumatic drugs (DMARDs), according to a company news release.

Tofacitinib, a selective oral Janus kinase (JAK) inhibitor, interrupts signaling of several cytokines involved in immune response. It was first approved by the FDA in 2012 for adults with moderately to severely active rheumatoid arthritis (RA) who have not responded adequately to, or are intolerant of, methotrexate.

The FDA approval of tofacitinib for PsA was based on data from the phase 3 Oral Psoriatic Arthritis Trial (OPAL) clinical development program, which consisted of two studies, OPAL Broaden and OPAL Beyond, as well as an ongoing long-term extension trial, OPAL Balance.

The findings from OPAL Broaden and OPAL Beyond were published in October in the New England Journal of Medicine and were reported by Medscape Medical News at that time.

Both 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 score at 3 months in patients receiving Xeljanz 5 mg twice daily in combination with a nonbiologic DMARD, compared to those receiving placebo.

In OPAL Broaden, 50% of patients taking tofacitinib 5 mg twice daily achieved an ACR20 response, compared to 33% of patients taking placebo (P ≤ .05), at 3 months. In OPAL Beyond, 50% of patients achieved an ACR20 response with tofacitinib 5 mg twice daily, compared to 24% of patients taking placebo (P ≤ .05), at 3 months.

In both studies, statistically significant improvements in ACR20 response were also seen with tofacitinib compared to placebo at 2 weeks, a secondary endpoint (OPAL Broaden: 22% and 6% [P = .0003], respectively; OPAL Beyond: 27% and 13% [P = .0046], respectively).

The safety profile of tofacitinib observed in patients with PsA was consistent with the safety profile observed in rheumatoid arthritis patients. The most common adverse events (>3% of patients) were nasopharyngitis, upper respiratory tract infection, headache, and diarrhea.

The tofacitinib label cautions that patients treated with the drug are at increased risk of developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. If a serious infection develops, tofacitinib should be interrupted until the infection is controlled. Full prescribing information is available online.

"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," OPAL study investigator Philip Mease, MD, from the Swedish Medical Center, University of Washington, Seattle, said in the company release. "I'm pleased that Xeljanz is now available for use in the treatment of this chronic condition."

"Psoriatic arthritis is a serious and debilitating chronic illness that should be diagnosed and treated early," Randy Beranek, president and CEO, National Psoriasis Foundation, said in the release. "As an organization that advocates for people living with psoriatic arthritis, we welcome the availability of new therapies for treating this disease."

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