Deucravacitinib (Sotyktu, Bristol Myers Squibb) performed well in two Phase 3 studies of adults with active psoriatic arthritis (PsA).
Both trials met their primary endpoint, with a significantly greater proportion of deucravacitinib -treated patients achieving ACR20 response (at least a 20% improvement in signs and symptoms of disease) after 16 weeks of treatment compared with placebo.
The POETYK PsA-1 and POETYK PsA-2 trials also met important secondary endpoints across PsA disease activity at Week 16. The overall safety profile of deucravacitinib through 16 weeks of treatment in the POETYK PsA-1 and POETYK PsA-2 trials was consistent with the established safety profile of deucravacitinib observed in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials.
“These POETYK PsA-1 and POETYK PsA-2 findings demonstrate that oral Sotyktu has the potential to be the first TYK2 inhibitor for people living with psoriatic arthritis and reinforce the established efficacy and safety profile of Sotyktu,” says Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squib, in a news release. “We are encouraged by the positive data across both Phase 3 trials and look forward to discussing the results with health authorities.”
Bristol Myers Squibb will work with key investigators to present detailed results at upcoming medical congresses. Deucravacitinib is approved in numerous countries around the world for the treatment of adults with moderate to severe plaque psoriasis.
