FDA News

FDA approves Xeljanz for adults with psoriatic arthritis

The FDA has approved Xeljanz for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate and disease-modifying antirheumatic drugs, according to a company press release.

Xeljanz (tofacitinib citrate, Pfizer) — available in 5 mg twice daily and extended-release 11 mg once daily formulations — is the only JAK inhibitor approved to treat both moderate-to-severe rheumatoid arthritis and PsA.

philip mease, md
Philip J. Mease

“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,” study investigator Philip J. Mease, MD, of the Swedish Medical Center and University of Washington School of Medicine, Seattle, said in the release. “I’m pleased that Xeljanz is now available for use in the treatment of this chronic condition.”

Tofacitinib is recommended for use in combination with nonbiologic DMARDs, and not recommended for use in combination with biologic DMARDs or with immunosuppressants, such as azathioprine and cyclosporine.

The FDA based its approval on data from the phase 3 Oral Psoriatic Arthritis Trial (OPAL) clinical development program, which comprised two pivotal studies, OPAL Broaden and OPAL Beyond, and on existing data from the long-term extension trial, OPAL Balance.

Primary efficacy endpoints for both the OPAL Broaden and OPAL Beyond studies were met, with statistically significant improvements in ACR20 response and change from baseline in the Health Assessment Questionnaire–Disability Index score at 3 months among patients receiving tofacitinib 5 mg twice daily in combination with a nonbiologic DMARD vs. patients receiving placebo.

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

Statistically significant improvements in ACR20 response was observed in both studies with tofacitinib 5 mg twice daily vs. placebo at week 2, a secondary endpoint and the first postbaseline assessment (OPAL Broaden: 22% and 6% [P = .0003], respectively; OPAL Beyond: 27% and 13% [P = .0046], respectively).

“Psoriatic arthritis is a serious and debilitating chronic illness that should be diagnosed and treated early,” Randy Beranek, president and CEO of the 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.”

According to the FDA, the most common adverse events observed occurring in more than 3% of patients who received the tofacitinib 5 mg formulation were nasopharyngitis, upper respiratory tract infection, headache and diarrhea; the safety profile among patients with active psoriatic arthritis treated with tofacitinib was consistent with the safety profile observed in patients with rheumatoid arthritis. 

The FDA has approved Xeljanz for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate and disease-modifying antirheumatic drugs, according to a company press release.

Xeljanz (tofacitinib citrate, Pfizer) — available in 5 mg twice daily and extended-release 11 mg once daily formulations — is the only JAK inhibitor approved to treat both moderate-to-severe rheumatoid arthritis and PsA.

philip mease, md
Philip J. Mease

“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,” study investigator Philip J. Mease, MD, of the Swedish Medical Center and University of Washington School of Medicine, Seattle, said in the release. “I’m pleased that Xeljanz is now available for use in the treatment of this chronic condition.”

Tofacitinib is recommended for use in combination with nonbiologic DMARDs, and not recommended for use in combination with biologic DMARDs or with immunosuppressants, such as azathioprine and cyclosporine.

The FDA based its approval on data from the phase 3 Oral Psoriatic Arthritis Trial (OPAL) clinical development program, which comprised two pivotal studies, OPAL Broaden and OPAL Beyond, and on existing data from the long-term extension trial, OPAL Balance.

Primary efficacy endpoints for both the OPAL Broaden and OPAL Beyond studies were met, with statistically significant improvements in ACR20 response and change from baseline in the Health Assessment Questionnaire–Disability Index score at 3 months among patients receiving tofacitinib 5 mg twice daily in combination with a nonbiologic DMARD vs. patients receiving placebo.

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

Statistically significant improvements in ACR20 response was observed in both studies with tofacitinib 5 mg twice daily vs. placebo at week 2, a secondary endpoint and the first postbaseline assessment (OPAL Broaden: 22% and 6% [P = .0003], respectively; OPAL Beyond: 27% and 13% [P = .0046], respectively).

“Psoriatic arthritis is a serious and debilitating chronic illness that should be diagnosed and treated early,” Randy Beranek, president and CEO of the 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.”

According to the FDA, the most common adverse events observed occurring in more than 3% of patients who received the tofacitinib 5 mg formulation were nasopharyngitis, upper respiratory tract infection, headache and diarrhea; the safety profile among patients with active psoriatic arthritis treated with tofacitinib was consistent with the safety profile observed in patients with rheumatoid arthritis.