Tofacitinib Approved for Active Psoriatic Arthritis

Pfizer this week announced that the FDA has approved tofacitinib (Xeljanz/Xeljanz XR) for the treatment of patients with active psoriatic arthritis (PsA) who did not respond or are intolerant to methotrexate and other disease-modifying antirheumatic drugs (DMARDs), according to a company press release.

The FDA issued approval for tofacitinib 5-mg twice per day and extended release 11-mg once-daily doses of PsA.

Tofacitinib is the first and only Janus kinase inhibitor indicated to treat both moderate-to-severe rheumatoid arthritis (RA) and active PsA, according to the release.

“Psoriatic arthritis is a complex and progressive disease with an unpredictable course,” said Angela Hwang, Global President, Inflammation and Immunology, Pfizer. “The approval of XELJANZ is an important step forward for patients seeking new treatments and is a testament to Pfizer’s unwavering commitment to advancing patient care.”

The new approval was based on positive findings from the phase 3 OPAL clinical development program, which included the OPAL Broaden, OPAL Beyond, and OPAL Balance studies.

Both OPAL Broaden and OPAL Beyond met their primary efficacy endpoints, showing improvements in ACR20 response and baseline change in disability at 3 months among patients treated with tofacitinib 5-mg plus nonbiologic DMARD, according to the release.

In the OPAL Broaden trial, 50% of patients achieved ACR20 compared with 33% of placebo-treated patients. In the OPAL Beyond trial, 50% achieved ACR30 compared with 24% of the placebo cohort, Pfizer reported.

The investigators noted statistically significant improvements in response to tofacitinib at 2 weeks compared with placebo, a secondary endpoint.

“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 researcher Philip Mease, MD, Swedish Medical Center, University of Washington. “I’m pleased that Xeljanz is now available for use in the treatment of this chronic condition.”

Pfizer said that the tofacitinib safety profile in PsA was consistent with findings in RA clinical trials. Common adverse events included nasopharyngitis, upper respiratory tract infection, headache, and diarrhea, according to the release.

The FDA advises against combining the use of tofacitinib with biologic DMARDs or immunosuppressants, according to the release.

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