Bristol Myers Squibb Announces Positive Topline Results in Phase 3 Sotyktu Trials

December 31, 2024

December 31, 2024
Tags: psoriatic arthritis
Original Article
Article, Psoriatic Arthritis

In a recent press release, Bristol Myers Squibb announced the positive results of their pivotal Phase 3 trials (POETYK PsA-1 and POETYK PsA-2) evaluating the safety and efficacy of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). Sotyktu was previously approved for the treatment of moderate-to-severe plaque psoriasis in adults, highlighting its established efficacy in addressing immune-mediated diseases.

Results of the clinical trials reveal that Sotyktu met the primary endpoint with a significant proportion of participants achieving an ACR20 response (at least a 20 percent improvement in signs and symptoms of disease) at Week 16 compared with placebo. Furthermore, the overall safety profile of Sotyktu remained consistent with the established safety profile observed in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials.

The two Phase 3, multicenter, randomized, double-blind, placebo-controlled trials evaluated the safety and efficacy of Sotyktu in patients aged 18 years and above with active PsA. The POETYK PsA-1 trial involved approximately 670 patients with active PsA who had not been previously treated with biologic disease-modifying antirheumatic drugs (bDMARD-naïve). Meanwhile, the POETYK PsA-2 trial enrolled about 730 patients with active PsA, including those who were bDMARD-naïve or had prior experience with TNFα inhibitor therapy. Both studies featured a 52-week treatment duration, starting with a placebo-controlled phase up to Week 16, followed by reallocation and continuation of active treatment from Week 16 to Week 52.

Speaking of this latest news, Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb, stated, “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. 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 3 trials and look forward to discussing the results with health authorities.”