Bristol Myers Squibb Presents Late-Breaking Phase 3 Data Showing Sotyktu’s Superiority in Psoriatic Arthritis
Bristol Myers Squibb (NYSE:BMY) today announced positive results from the pivotal Phase 3 POETYK PsA-2 trial (IM011-055), which evaluated the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). The trial met its primary endpoint, with a significantly higher percentage of patients receiving Sotyktu achieving an ACR20 response (at least a 20% improvement in disease signs and symptoms) compared to those on placebo at Week 16 (54.2% vs. 39.4%, p=0.0002). The safety profile of Sotyktu over the 16-week treatment period was consistent with data from earlier Phase 2 PsA and Phase 3 plaque psoriasis studies.
These new findings, which mark the first disclosure of data from the Phase 3 POETYK trials in PsA, are being presented as a late-breaking abstract (#66894) at the American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida, taking place from March 7-11, 2025.
“Psoriatic arthritis is a complex and multifaceted disease, and there remains a significant need for safe and effective oral treatments,” said Dr. Philip Mease, Director of Rheumatology Research at Swedish Medical Center/Providence St. Joseph Health and Clinical Professor at the University of Washington School of Medicine, Seattle. “These results are particularly encouraging because they show Sotyktu’s potential to address both joint and skin symptoms of PsA while also improving patient-reported quality of life. Combined with a well-tolerated safety profile, these findings suggest that Sotyktu could become an important treatment option for patients with PsA.”
Primary Endpoint and Secondary Endpoints
The POETYK PsA-2 trial met its primary endpoint, with a significantly greater proportion of patients treated with Sotyktu achieving an ACR20 response (defined as at least a 20% improvement in signs and symptoms of disease) compared to those treated with placebo at Week 16. Specifically, 54.2% of Sotyktu-treated patients reached an ACR20 response, compared to 39.4% of those on placebo (p=0.0002).
In addition to the primary endpoint, Sotyktu demonstrated significant improvement across key secondary endpoints. These included clinical signs and symptoms of PsA, extra-articular manifestations, and patient-reported outcomes. Notably, significantly more Sotyktu-treated patients achieved a Psoriasis Area and Severity Index (PASI) 75 response (indicating a 75% improvement in psoriasis symptoms) compared to those receiving placebo. Furthermore, Sotyktu led to significantly greater improvements from baseline in the patient-reported Health Assessment Questionnaire-Disability Index (HAQ-DI) compared to placebo (−0.32 vs. −0.21, respectively; p=0.0013).
Safety Profile
The safety profile of Sotyktu through the 16-week treatment period was consistent with what has been observed in previous clinical trials for PsA and psoriasis. No new safety signals were identified in the POETYK PsA-2 trial. In terms of adverse events (AEs), 54.7% of patients in the placebo group, 62.8% in the Sotyktu group, and 73.3% in the apremilast group reported AEs.
Serious AEs were reported in 1.0%, 1.9%, and 3.8% of patients in the placebo, Sotyktu, and apremilast groups, respectively. Treatment discontinuations due to AEs were low across all groups, with 1.3% in the placebo group, 2.2% in the Sotyktu group, and 10.5% in the apremilast group. It’s important to note that apremilast was included as a safety reference arm in the trial, although no formal statistical comparisons were made for efficacy between Sotyktu and apremilast.
“These data demonstrate the potential of Sotyktu as an oral therapy and as the first TYK2 inhibitor that could address significant unmet needs in the treatment of psoriatic arthritis,” said Dr. Edgar Charles, Vice President and Senior Global Program Lead for Early & Late Development Immunology at Bristol Myers Squibb. “These results further strengthen our belief in Sotyktu’s potential in rheumatic diseases and reflect our ongoing commitment to developing innovative treatments for patients with immune-mediated conditions.”
Future Data Presentations and Regulatory Discussions
Bristol Myers Squibb plans to present additional data from the Phase 3 POETYK PsA program at upcoming medical congresses throughout the year. The company also looks forward to discussing these results with health authorities as it continues to move forward with its regulatory filings.
Sotyktu is already approved in numerous countries for the treatment of moderate-to-severe plaque psoriasis in adults and is being investigated in other immune-mediated conditions.
About the Phase 3 Psoriatic Arthritis Trials
The Phase 3 Sotyktu PsA program includes two multicenter, randomized, double-blind, placebo-controlled trials: POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055). These trials evaluate the efficacy and safety of Sotyktu in adults aged 18 and older with active PsA. POETYK PsA-1 enrolled approximately 670 bDMARD-naïve patients, while POETYK PsA-2 enrolled approximately 730 bDMARD-naïve patients or those previously treated with TNFα inhibitors. Both trials have a 52-week treatment period, including a placebo-controlled period through Week 16, followed by continued active treatment from Week 16 to Week 52. Patients who complete 52 weeks of treatment may be eligible for an open-label extension study.
The primary endpoint in both trials is the proportion of patients achieving an ACR20 response at Week 16, and important secondary endpoints assess PsA disease activity measures.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic, immune-mediated disease characterized by inflammation in the joints, tendons, and skin. Up to 30% of patients with psoriasis will develop PsA, which can lead to significant pain, fatigue, and loss of physical function. PsA also poses an increased risk for comorbid conditions such as cardiovascular disease, metabolic syndrome, and mental health disorders, including depression and anxiety. This makes effective treatment options essential for managing the disease and improving quality of life for patients.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines for patients with serious diseases. With a focus on immunology, oncology, cardiovascular diseases, and fibrosis, Bristol Myers Squibb strives to address the most challenging health issues and improve patient outcomes worldwide.
