Positive topline resultsannounced from two pivotal phase III trials evaluating Sotyktu (deucravacitinib) in adults with psoriatic arthritis.- BMS

Bristol Myers Squibb announced results from POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), the pivotal Phase III trials evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). Both trials met their primary endpoint, with a significantly greater proportion of Sotyktu -treated patients achieving ACR20 response (at least a 20 percent improvement in signs and symptoms of disease) after 16 weeks of treatment compared with placebo.

Additionally, the POETYK PsA-1 and POETYK PsA-2 trials met important secondary endpoints across PsA disease activity at Week 16. The overall safety profile of Sotyktu through 16 weeks of treatment in the POETYK PsA-1 and POETYK PsA-2 trials was consistent with the established safety profile of Sotyktu observed in a Phase II PsA clinical trial and Phase III moderate-to-severe plaque psoriasis clinical trials.

"Psoriatic arthritis is a heterogenous disease that causes a range of different symptoms, including joint pain and swelling, as well as psoriatic skin lesions. Despite available therapies, rheumatologists continue to express a need for a safe and effective oral treatment," said Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb. "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 . We are encouraged by the positive data across both Phase III trials and look forward to discussing the results with health authorities."

These topline results represent the first Phase III clinical trials for Sotyktu in a rheumatic condition. Sotyktu is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis.

About the Sotyktu Phase III Psoriatic Arthritis Trial Program: The Phase III Sotyktu psoriatic arthritis (PsA) program includes two Phase III, multicenter, randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety in adults 18 years of age and older with active PsA: POETYK PsA-1 (IM011-054; NCT04908202 ) and POETYK PsA-2 (IM011-055; NCT04908189 ).

POETYK PsA-1 enrolled approximately 670 patients with active PsA who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD naïve). POETYK PsA-2 enrolled approximately 730 patients with active PsA who were bDMARD naïve or had previously received TNFα inhibitor treatment. Both trials include a 52-week treatment period comprised of a placebo-controlled treatment period through Week 16, followed by a reallocation and continued active treatment period from Week 16 to Week 52. POETYK PsA-2 also included an apremilast safety reference arm.

The primary endpoint of both trials was the proportion of participants achieving an ACR20 response at Week 16. Important secondary endpoints were also assessed at Week 16 across measures of PsA disease activity.

Patients in both trials completing 52 weeks of treatment are potentially eligible to enroll in the open-label extension study.