Long-term Data Suggests Deucravacitinib Safe, Effective for Treating Plaque Psoriasis

New safety data from the POETYK PSO long-term extension (LTE) trial showed deucravacitinib, an oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor, was clinically effective and safe for treating adult patients with moderate-to-severe plaque psoriasis, according to a release from Bristol Myers Squibb. Efficacy was maintained for up to 2 years, with 77.7% of patients achieving Psoriasis Area and Severity Index (PASI) 75 by week 60 and 58.7% achieving the static Physicians Global Assessment (sPGA) response rate of 0/1 (clear/almost clear skin).

Spanning 2482 patient years, results are consistent with previous phase 3, multicenter, randomized, double-blind POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials, which evaluated the safety and efficacy of deucravacitinib compared with apremilast and placebo for the treatment of moderate-to-severe plaque psoriasis. Common adverse events (AEs) reported, of which most were mild to moderate in severity, were headache, upper respiratory tract infection, and nasopharyngitis. Rates of serious AEs remained low during the 2-year LTE trial. The drug did not increase a patient’s risk of developing COVID-19 nor did it impact the severity of COVID-19 infection. No clinically meaningful changes from baseline were observed in laboratory values.

The drug represents a new class of small molecules and is the first and only TYK2 inhibitor being studied across multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus, and inflammatory bowel diseases. Deucravacitinib selectively inhibits TYK2, but does not interfere with JAK1, JAK2, or JAK3. It is currently under review with the US Food and Drug Administration (FDA), European Medical Association (EMA), and Japan’s Ministry of Health, Labor, and Welfare for the treatment of moderate-to-severe plaque psoriasis.

“Plaque psoriasis is a chronic, systemic immune-mediated disease associated with multiple serious comorbidities, and there remains a strong unmet need for new treatments, particularly oral medicines, as many patients are undertreated or are dissatisfied with current options,” stated Richard B Warren, Professor at The University of Manchester. “Long-term research showing durable efficacy, in addition to a well understood safety profile, is critical for clinicians and patients making treatment decisions, and these new two-year data underscore the potential of deucravacitinib to be an important new oral treatment option for people living with moderate to severe plaque psoriasis who require systemic therapy.”