Bristol Myers Squibb Reports Positive Phase 3 Trial Results for Sotyktu in Psoriatic Arthritis

Bristol Myers Squibb has announced promising outcomes from the critical Phase 3 trials, POETYK PsA-1 and POETYK PsA-2, which were designed to evaluate the efficacy and safety of Sotyktu (deucravacitinib) for adults dealing with active psoriatic arthritis (PsA). Both trials achieved their primary goals, showcasing that significantly more patients treated with Sotyktu reached an ACR20 response—a benchmark indicating at least a 20% improvement in disease symptoms—after 16 weeks, as compared to those on placebo.

Besides the primary endpoints, significant secondary endpoints regarding PsA disease activity were also met by Week 16 in both trials. The safety profile of Sotyktu was consistent with what had been previously observed in earlier Phase 2 PsA and Phase 3 moderate-to-severe plaque psoriasis trials. Dr. Roland Chen, Bristol Myers Squibb's senior vice president overseeing Immunology, Cardiovascular, and Neuroscience development, highlighted the trials’ success in demonstrating the potential of Sotyktu as the first TYK2 inhibitor for PsA, emphasizing the unmet need for effective oral treatments for the condition.

The results mark Sotyktu’s debut in Phase 3 clinical trials within a rheumatic context. The drug is already approved globally for treating moderate-to-severe plaque psoriasis in adults. The company intends to present detailed findings from these trials at future medical conferences, working closely with key researchers.

The Phase 3 Sotyktu PsA program features two comprehensive trials: POETYK PsA-1 and POETYK PsA-2. These multicenter, randomized, double-blind studies involved adults 18 and older with active PsA. The first trial, POETYK PsA-1, included approximately 670 biologic disease-modifying antirheumatic drug (bDMARD) naïve patients, while the second, POETYK PsA-2, included about 730 participants who were either bDMARD naïve or had prior treatment with TNFα inhibitors. Both trials featured a 52-week treatment period, starting with a placebo-controlled phase until Week 16, followed by a reallocation and continued active treatment until Week 52. Notably, POETYK PsA-2 also included an apremilast safety reference arm.

The primary endpoint was the percentage of participants achieving an ACR20 response by Week 16, with additional secondary endpoints evaluating various aspects of PsA disease activity. Participants who completed 52 weeks of treatment are eligible to join an open-label extension study.

Psoriatic arthritis is a chronic, immune-mediated condition characterized by varied symptoms, including joint inflammation, enthesitis, dactylitis, and psoriatic skin and nail changes. A significant portion of individuals with psoriasis—up to 30%—can develop PsA. Beyond physical symptoms, PsA can affect mental and emotional health and heighten the risk of comorbid conditions like cardiovascular disease, metabolic syndrome, and mood disorders.

Sotyktu offers a novel approach by selectively inhibiting tyrosine kinase 2 (TYK2), a key player in the immune system’s response to cytokines involved in several immune-mediated diseases. This selective targeting allows Sotyktu to inhibit critical pathways without affecting other Janus kinases (JAK1, JAK2, JAK3). The drug is approved in numerous countries for treating moderate-to-severe plaque psoriasis.

Bristol Myers Squibb continues to innovate in the field of immunology, aiming to provide transformative treatments for patients with immune-mediated diseases. The company’s research and development efforts focus on addressing the root causes of diseases through advanced immunotherapy strategies, aiming for improved patient outcomes and quality of life.