Bristol Myers Squibb Announces Positive Phase 3 POETYK PsA-1 Trial Results

"Bristol Myers Squibb presents late-breaking data from pivotal phase 3 POETYK PsA-1 trial demonstrating superiority of Sotyktu compared with placebo in adults with psoriatic arthritis

Overview

Bristol Myers Squibb announced positive data from the pivotal phase 3 POETYK PsA-1 trial (IM011-054) evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA) who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD). The trial met its primary endpoint, with a significantly greater proportion of patients treated with Sotyktu achieving ACR20 response (at least a 20 percent improvement in signs and symptoms of disease) compared with placebo at Week 16 (54.2% versus 34.1%, respectively; p<0.0001). The safety profile of Sotyktu through 16 weeks of treatment was consistent with what has been reported throughout the clinical trial programs for Sotyktu, including the phase 3 POETYK PsA-2 trial and the phase 3 moderate-to-severe plaque psoriasis (PsO) clinical trials.

The data for POETYK PsA-1 are being presented as a late-breaking abstract (#LB0001) at the European Alliance of Associations for Rheumatology (EULAR) Congress in Barcelona, Spain, taking place June 11-14, 2025.

Statement from Philip Mease: MD, Director of rheumatology research

• “Psoriatic arthritis can be a complex, multifaceted and heterogeneous disease, underscoring the significant need to equip healthcare providers with new safe and effective oral treatment options,” said Philip Mease, MD, director of rheumatology research at Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, Seattle. 

• “Improvements in joint and skin symptoms, as well as quality of life, are important treatment goals, and the results demonstrated in this phase 3 study across these parameters highlight the potential of Sotyktu as a new way of treating this debilitating disease.”

The trial outcomes

• Patients treated with Sotyktu saw improvements across a wide range of clinical measures of disease activity, patient-reported outcomes and extra-articular manifestations of PsA at Week 16. 

• Importantly, several key secondary endpoints were met, including Psoriasis Area and Severity Index (PASI) 75 response, Health Assessment Questionnaire-Disability Index (HAQ-DI) score, 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) score and Minimal Disease Activity (MDA) response. 

• Additionally, improvements were observed for ACR50 and ACR70 responses. 

• Nominally significant differences were observed in Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) score, 28-Joint Disease Activity Score-C-Reactive Protein (DAS28-CRP) score and dactylitis resolution pooled analysis.

Sotyktu Shows Positive Radiographic Progression Data in PsA
• Week 16 post hoc analysis revealed inhibition of radiographic progression in PsA patients treated with Sotyktu.

• Prespecified analysis did not show statistical significance, but post hoc results confirmed a meaningful difference compared to placebo.

• More Sotyktu-treated patients had no radiographic progression at Week 16 versus placebo.

• No new safety signals identified, with the most common adverse event being upper respiratory tract infection (5.1% vs. 3.0% placebo).

• Serious AEs (1.8% vs. 2.4%) and discontinuations (2.4% vs. 1.8%) remained low through Week 16.

Words from the VP: Immunology and Cardiovascular, Bristol Myers Squibb
• “These positive phase 3 data build on the strong results from our POETYK phase 3 PsA-2 trial and underscore the potential of Sotyktu as an oral, first-in-class TYK2 inhibitor for people living with psoriatic arthritis,” said Dennis Grasela, PharmD, PhD, vice president and senior global program lead, Immunology and Cardiovascular, Bristol Myers Squibb. 

• “The potential of Sotyktu for this chronic, progressive disease exemplifies our commitment to the pursuit of transformative medicines for rheumatic conditions. We look forward to discussing the POETYK PsA-1 and PsA-2 results with global regulatory authorities.”

POETYK PsA-2 Trial Confirms Long-Term Efficacy of Sotyktu

• Superior efficacy of Sotyktu vs. placebo observed at Week 16.

• Clinical responses continued to improve through Week 52, maintaining outcomes for patients on continuous treatment or switching to Sotyktu.

• ACR20 response at Week 16: 54.2% (Sotyktu) vs. 39.4% (placebo) (p=0.0002).

• Week 52 results: 62.2% of patients on continuous treatment and 67.3% of switchers achieved ACR20 response.

• Secondary endpoints, including PASI 75, MDA, HAQ-DI, and SF-36 PCS scores, remained stable through Week 52.

• Sotyktu demonstrated a well-tolerated safety profile, consistent with previous PsA and PsO trials.

Bristol Myers Squibb Expands POETYK PsA Research & Global Reach

• Additional Phase 3 POETYK PsA data to be presented at upcoming medical congresses.

• Sotyktu is approved worldwide for treating moderate-to-severe plaque PsO in adults.

• BMS acknowledges the patients, investigators & clinical trial sites for their contributions to POETYK PsA-1 & PsA-2.

Phase 3 Sotyktu Psoriatic Arthritis (PsA) Trials Overview
• The Sotyktu PsA program consists of two Phase 3 trials: POETYK PsA-1 & POETYK PsA-2.

• Both are multicenter, randomized, double-blind, placebo-controlled studies.

• They evaluate efficacy & safety in adults 18+ with active psoriatic arthritis (PsA).

• Trial identifiers:
POETYK PsA-1: IM011-054 (NCT04908202)
POETYK PsA-2: IM011-055 (NCT04908189)

The POETYK PsA-1 trial
• 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 & Secondary outcomes

• 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. 

• POETYK PsA-1 also evaluated inhibition of progression of structural joint damage at Week 16 as a key secondary endpoint.

• Patients in both trials completing 52 weeks of treatment are potentially eligible to enroll in open-label extensions.

The medical condition: Psoriatic arthritis (PsA)
• 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 percent 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.

All about the drug: Sotyktu (deucravacitinib)

• Sotyktu (deucravacitinib) is an oral, selective 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: Approval & indication

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

• Sotyktu (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

• Sotyktu is not recommended for use in combination with other potent immunosuppressants.

The company: Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.