Tofacitinib meets primary endpoints in psoriatic arthritis phase 3 trial

Pfizer announced its Oral Psoriatic Arthritis TriaL (OPAL) BROADEN study of 5-mg and 10-mg daily tofacitinib for the treatment of adult patients with active psoriatic arthritis met primary efficacy goals of ACR20 response superior to placebo at 3 months, according to a press release.

All patients were naïve to tumor necrosis factor inhibitors and had an inadequate response to conventional disease-modifying anti-rheumatic drugs (DMARDs). A total of 422 patients were randomly assigned 2:2:2:1:1 to 5-mg daily tofacitinib (Xeljanz, Pfizer), 10-mg tofacitinib, 40-mg adalimumab (Humira, AbbVie) or placebo with a transition to 5-mg or 10-mg tofacitinib in addition to background DMARD therapy.

“As a chronic inflammatory disease, psoriatic arthritis can have a significant impact on a person’s daily life. Despite available therapies, including biologic and oral treatments, there remains an unmet need for additional options,” Michael Corbo, category development lead, Inflammation and Immunology at Pfizer Global Innovative Pharmaceuticals Business, said in a press release. “The results seen in the OPAL Broaden study are encouraging as they suggest that tofacitinib may have the potential to offer an additional effective oral option for patients living with psoriatic arthritis. We look forward to sharing detailed results at a future scientific meeting.”

Tofacitinib, a Janus kinase inhibitor, is currently approved in the United States to treat rheumatoid arthritis (RA) and has been studied in around 6,200 patients with RA with more than 19,400 patient-years of data.

Pfizer expects to use the data from this and two additional phase 3 studies to submit a regulatory application to the FDA seeking approval for the indication of treatment of psoriatic arthritis with tofacitinib.

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