BMS Presents Phase 3 POETYK PsA-2 Data Showing Sotyktu's Superiority

Bristol Myers Squibb announced positive data from the pivotal phase 3 POETYK PsA-2 trial (IM011-055) evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). The POETYK PsA-2 trial met its 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) compared with placebo at Week 16 (54.2% versus 39.4%, respectively; p=0.0002). The overall safety profile of Sotyktu through 16 weeks of treatment was consistent with that established in a phase 2 PsA clinical trial and phase 3 moderate-to-severe plaque psoriasis clinical trials.

The new data, which represent the first disclosure of data for 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 March 7-11, 2025.

“Given the complex, multifaceted and heterogenous nature of psoriatic arthritis, there continues to be a significant need for safe and effective oral treatments,” said Philip Mease, MD, 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 support the potential for Sotyktu to impact both joint and skin symptoms, as well as patient-reported quality of life outcomes. Combined with a well-tolerated safety profile, these data show Sotyktu may serve as an important new treatment option for these patients.”

Additionally, treatment with Sotyktu met important secondary endpoints across PsA disease activity at Week 16, demonstrating improvement across clinical signs and symptoms, extra-articular manifestations and patient-reported outcomes. Significantly more Sotyktu -treated patients achieved a Psoriasis Area and Severity Index (PASI) 75 response compared with placebo. Treatment with Sotyktu also resulted in significantly greater improvements from baseline in the patient-reported Health Assessment Questionnaire-Disability Index (HAQ-DI) compared with placebo (-0.32 versus -0.21, respectively; p=0.0013).

In the POETYK PsA-2 trial, no new safety signals were identified. In the placebo, Sotyktu and apremilast arms, adverse events (AEs) were reported in 54.7%, 62.8% and 73.3% of patients, respectively, and serious AEs in 1.0%, 1.9% and 3.8%, respectively. AEs led to discontinuation in 1.3%, 2.2% and 10.5% in the placebo, Sotyktu and apremilast arms, respectively. Apremilast was included as a safety reference arm in the PsA-2 trial with no formal statistical comparisons planned for efficacy.

“These promising new data demonstrate the potential of Sotyktu as an oral therapy and the first TYK2 inhibitor that may be able to address significant unmet needs of patients living with psoriatic arthritis,” said Edgar Charles, MD, vice president and senior global programme lead, Early & Late Development Immunology, Bristol Myers Squibb. “Furthermore, these results support our belief in the capability of Sotyktu in rheumatic conditions and reflect our ongoing commitment to developing medicines for people living with immune-mediated diseases.”

Bristol Myers Squibb will work with key investigators to present additional data from the phase 3 POETYK PsA program at upcoming medical congresses this year and looks forward to discussing these results with health authorities.

Sotyktu is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis.

Bristol Myers Squibb thanks the patients, investigators and clinical trial sites who participated in POETYK PsA-2.

The phase 3 Sotyktu psoriatic arthritis (PsA) program includes two phase 3, 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 TNFa 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.

Psoriatic arthritis (PsA) is a chronic, immune-mediated, heterogenous disease with multiple musculoskeletal and skin manifestations, including inflammatory arthritis, enthesitis (inflammation where tendon or ligament attaches to the bone), dactylitis (swelling of finger and toe joints) and psoriatic skin and nail lesions. Up to 30 per cent of patients with psoriasis will develop PsA. In addition to the loss of physical function, pain and fatigue caused by PsA, the disease can significantly impact the mental and emotional well-being of patients. Patients with PsA are also at increased risk of serious comorbidities, including cardiovascular disease, metabolic syndrome, depression and anxiety.

Sotyktu (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, representing a new class of small molecules. It is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed Sotyktu to selectively target TYK2, thereby inhibiting signalling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Sotyktu achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Sotyktu selectively inhibits TYK2 at physiologically relevant concentrations. At therapeutic doses, Sotyktu does not inhibit JAK1, JAK2 or JAK3.

Sotyktu is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis.

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can make simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, we continue to pursue bold science as we work to deliver life-changing medicines that elevate new standards of care across rheumatology, dermatology and pulmonology. Our sequential immunotherapy research framework aims to address the root cause of disease by controlling inflammation, resetting the immune system and promoting immune homeostasis with the goal of achieving transformational efficacy. By continuously pushing the boundaries of scientific knowledge, we strive to bring forward tailored approaches, treatments and combinations that may lead to durable remissions, improved quality of life and functional cures. Our collaborations with patients, caregivers,

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!