{"id":61406,"date":"2025-06-11T13:02:30","date_gmt":"2025-06-11T11:02:30","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/bristol-myers-squibb-presents-late-breaking-data-from-pivotal-phase-3-poetyk-psa-1-trial-demonstrating-superiority-of-sotyktu-deucravacitinib-compared-with-placebo-in-adults-with-psoriatic-arthritis\/"},"modified":"2025-06-11T13:02:30","modified_gmt":"2025-06-11T11:02:30","slug":"bristol-myers-squibb-presents-late-breaking-data-from-pivotal-phase-3-poetyk-psa-1-trial-demonstrating-superiority-of-sotyktu-deucravacitinib-compared-with-placebo-in-adults-with-psoriatic-arthritis","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/bristol-myers-squibb-presents-late-breaking-data-from-pivotal-phase-3-poetyk-psa-1-trial-demonstrating-superiority-of-sotyktu-deucravacitinib-compared-with-placebo-in-adults-with-psoriatic-arthritis\/","title":{"rendered":"Bristol Myers Squibb Presents Late-Breaking Data from Pivotal Phase 3 POETYK PsA-1 Trial Demonstrating Superiority of Sotyktu (deucravacitinib) Compared with Placebo in Adults with Psoriatic Arthritis"},"content":{"rendered":"
\n

\nSignificantly more patients treated with <\/i>Sotyktu achieved improvements in joint and skin symptoms, measures of disease activity and quality of life at Week 16 in POETYK PsA-1<\/i><\/b><\/p>\n

\nNew data from POETYK PsA-2 trial demonstrated that meaningful clinical responses continued to improve and outcomes were maintained through Week 52<\/i><\/b><\/p>\n

\nSotyktu demonstrated safety consistent with the established clinical profile and was well tolerated in both studies, with no new safety signals<\/i><\/b><\/p>\n

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY<\/a> #EULAR<\/a>—Bristol Myers Squibb<\/a> (NYSE:BMY) today announced positive data from the pivotal Phase 3 POETYK PsA-1 trial (IM011-054) evaluating the efficacy and safety of Sotyktu<\/i> (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 <\/i>achieving <\/i>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<\/i> through 16 weeks of treatment was consistent with what has been reported throughout the clinical trial programs for Sotyktu<\/i>, including the Phase 3 POETYK PsA-2 trial and the Phase 3 moderate-to-severe plaque psoriasis (PsO) clinical trials.<\/p>\n

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\nThe 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.<\/p>\n

\n\u201cPsoriatic 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,\u201d 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. \u201cImprovements 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 <\/i>as a new way of treating this debilitating disease.\u201d<\/p>\n

\nPatients treated with Sotyktu<\/i> 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.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\nPsA-1 efficacy endpoints at Week 16<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nCategory<\/b><\/p>\n<\/td>\n

\n

\nEndpoint<\/b><\/p>\n<\/td>\n

\n

\nSotyktu<\/i><\/b><\/p>\n

\n6 mg<\/b><\/p>\n

\nonce daily<\/b><\/p>\n

\nn=336<\/b><\/p>\n<\/td>\n

\n

\nPlacebo<\/b><\/p>\n

\nn=334<\/b><\/p>\n<\/td>\n

\n

\nP value<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nClinical efficacy<\/p>\n<\/td>\n

\n

\nACR20 response, %<\/p>\n<\/td>\n

\n

\n54.2<\/p>\n<\/td>\n

\n

\n34.1<\/p>\n<\/td>\n

\n

\n<0.0001*<\/p>\n<\/td>\n<\/tr>\n

\n

\nACR50 response, %<\/p>\n<\/td>\n

\n

\n24.7<\/p>\n<\/td>\n

\n

\n13.5<\/p>\n<\/td>\n

\n

\n0.0002**<\/p>\n<\/td>\n<\/tr>\n

\n

\nACR70 response, %<\/p>\n<\/td>\n

\n

\n11.6<\/p>\n<\/td>\n

\n

\n5.4<\/p>\n<\/td>\n

\n

\n0.0039**<\/p>\n<\/td>\n<\/tr>\n

\n

\nPASI 75 response,a<\/sup> %<\/p>\n<\/td>\n

\n

\n51.9<\/p>\n<\/td>\n

\n

\n7.1<\/p>\n<\/td>\n

\n

\n<0.0001*<\/p>\n<\/td>\n<\/tr>\n

\n

\nMDA response, %<\/p>\n<\/td>\n

\n

\n19.0<\/p>\n<\/td>\n

\n

\n10.2<\/p>\n<\/td>\n

\n

\n0.0012*<\/p>\n<\/td>\n<\/tr>\n

\n

\nDAS28-CRP score, mean CfB<\/p>\n<\/td>\n

\n

\n-1.33<\/p>\n<\/td>\n

\n

\n-0.83<\/p>\n<\/td>\n

\n

\n<0.0001**<\/p>\n<\/td>\n<\/tr>\n

\n

\nPatient-reported outcomes<\/p>\n<\/td>\n

\n

\nHAQ-DI score, mean CfB<\/p>\n<\/td>\n

\n

\n-0.39<\/p>\n<\/td>\n

\n

\n-0.22<\/p>\n<\/td>\n

\n

\n<0.0001*<\/p>\n<\/td>\n<\/tr>\n

\n

\nSF-36 PCS score, mean CfB<\/p>\n<\/td>\n

\n

\n6.06<\/p>\n<\/td>\n

\n

\n3.71<\/p>\n<\/td>\n

\n

\n<0.0001*<\/p>\n<\/td>\n<\/tr>\n

\n

\nFACIT-Fatigue score, mean CfB<\/p>\n<\/td>\n

\n

\n4.6<\/p>\n<\/td>\n

\n

\n2.0<\/p>\n<\/td>\n

\n

\n<0.0001**<\/p>\n<\/td>\n<\/tr>\n

\n

\nExtra-articular manifestations of PsA<\/p>\n

\n(pooled POETYK PsA-1 and POETYK PsA-2 analyses)<\/i><\/p>\n<\/td>\n

\n

\nLEI enthesitis<\/p>\n

\nresolution,b<\/sup> %<\/p>\n<\/td>\n

\n

\n50.3<\/p>\n<\/td>\n

\n

\n45.1<\/p>\n<\/td>\n

\n

\n0.1781<\/p>\n<\/td>\n<\/tr>\n

\n

\nSPARCC enthesitis resolution,c<\/sup> %<\/p>\n<\/td>\n

\n

\n47.1<\/p>\n<\/td>\n

\n

\n36.1<\/p>\n<\/td>\n

\n

\n0.0018**<\/p>\n<\/td>\n<\/tr>\n

\n

\nDactylitis resolution,d<\/sup> %<\/p>\n<\/td>\n

\n

\n57.6<\/p>\n<\/td>\n

\n

\n44.1<\/p>\n<\/td>\n

\n

\n0.0100**<\/p>\n<\/td>\n<\/tr>\n<\/table>\n\n\n\n\n\n
*Statistically significant.<\/td>\n<\/tr>\n
**Nominally significant.<\/td>\n<\/tr>\n
ACR20, American College of Rheumatology 20% improvement in response; ACR50, American College of Rheumatology 50% improvement in response; ACR70, American College of Rheumatology 70% improvement in response; BSA, body surface area; CfB, change from baseline; LEI, Leeds Enthesitis Index; SPARCC, Spondyloarthritis Research Consortium of Canada; sPGA, static Physician Global Assessment.<\/td>\n<\/tr>\n
\n

\na<\/sup>Assessed in all randomized patients with \u22653% BSA and a sPGA score of \u22652 at baseline (placebo, n=170; Sotyktu<\/i>, <\/i>n=162); b<\/sup>Assessed in pooled patients from POETYK PsA-1 and POETYK PsA-2 in patients with an LEI score \u22651 at baseline (placebo, n=317; Sotyktu<\/i>, n=318); c<\/sup>Assessed in pooled patients from POETYK PsA-1 and POETYK PsA-2 in patients with SPARCC score \u22651 at baseline (placebo, n=407; Sotyktu<\/i>, n=393); d<\/sup>Assessed in pooled patients from POETYK PsA-1 and POETYK PsA-2 in patients with an tender dactylitis count of \u22651 at baseline (placebo, n=188; Sotyktu<\/i>, n=210).<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nIn addition, inhibition of radiographic progression was observed with Sotyktu<\/i> at Week 16 in post hoc analyses. While the prespecified analysis did not show a statistically significant difference between Sotyktu<\/i> and placebo in mean change from baseline (CfB) in the modified Sharp-van der Heijde (mSvdH) score, results from a post hoc analysis demonstrated a statistically significant difference between the treatment groups. Further, a significantly greater proportion of patients treated with Sotyktu<\/i> did not have radiographic progression (defined as a CfB to Week 16 in mSvdH score of less than or equal to 0) versus placebo.<\/p>\n

\nNo new safety signals were identified in the POETYK PsA-1 trial. The most frequent adverse event (AE) in both the Sotyktu<\/i> and placebo arms was upper respiratory tract infection (5.1% versus 3.0%, respectively). Serious AEs (1.8% versus 2.4%, respectively) and AEs that led to discontinuation (2.4% versus 1.8%, respectively) were infrequent though Week 16.<\/p>\n

\n\u201cThese positive Phase 3 data build on the strong results from our POETYK Phase 3 PsA-2 trial and underscore the potential of Sotyktu <\/i>as an oral, first-in-class TYK2 inhibitor for people living with psoriatic arthritis,\u201d said Dennis Grasela, PharmD, PhD, vice president and senior global program lead, Immunology and Cardiovascular, Bristol Myers Squibb. \u201cThe potential of Sotyktu <\/i>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.\u201d<\/p>\n

\nContinued improvement of clinical responses and maintenance of outcomes through Week 52 in POETYK PsA-2<\/b><\/p>\n

\nAdditionally, new data from the pivotal Phase 3 POETYK PsA-2 trial (abstract #OP0095), which evaluated patients with active PsA who were bDMARD na\u00efve or had previously received TNF\u03b1 inhibitor treatment, is also being presented at the meeting. Results showed superior efficacy of Sotyktu<\/i> compared with placebo at Week 16. Additionally, through Week 52, clinical responses continued to improve for those who remained on or switched to Sotyktu<\/i> treatment, and outcomes were maintained for those receiving continuous Sotyktu<\/i> treatment.<\/p>\n

\nAt Week 16, 54.2% of Sotyktu<\/i>-treated patients achieved ACR20 response versus 39.4% of those receiving placebo (p=0.0002). At Week 52, 62.2% of patients receiving continuous Sotyktu<\/i> treatment and 67.3% of patients who switched from placebo to Sotyktu<\/i> after Week 16 achieved ACR20 response. Similar trends were observed for ACR50 and ACR70. Additionally, key secondary endpoints continued to be maintained with Sotyktu <\/i>treatment compared with placebo at Week 52, including PASI 75 response, MDA response, HAQ-DI score and SF-36 PCS score. Sotyktu<\/i> was well tolerated through Week 52, demonstrating a safety profile consistent with previous results of Sotyktu <\/i>in PsA and PsO.<\/p>\n

\nBristol Myers Squibb will work with key investigators to present additional data from the Phase 3 POETYK PsA program at upcoming medical congresses.<\/p>\n

\nSotyktu<\/i> is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque PsO.<\/p>\n

\nBristol Myers Squibb thanks the patients, investigators and clinical trial sites who participated in POETYK PsA-1 and POETYK PsA-2.<\/p>\n

\nAbout the Sotyktu<\/i> Phase 3 Psoriatic Arthritis Trial Program<\/b><\/p>\n

\nThe Phase 3 Sotyktu<\/i> 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<\/a>) and POETYK PsA-2 (IM011-055; NCT04908189<\/a>).<\/p>\n

\nPOETYK PsA-1 enrolled approximately 670 patients with active PsA who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD na\u00efve). POETYK PsA-2 enrolled approximately 730 patients with active PsA who were bDMARD na\u00efve or had previously received TNF\u03b1 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.<\/p>\n

\nThe 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.<\/p>\n

\nPatients in both trials completing 52 weeks of treatment are potentially eligible to enroll in open-label extensions.<\/p>\n

\nAbout Psoriatic Arthritis<\/b><\/p>\n

\nPsoriatic 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.<\/p>\n

\nAbout Sotyktu<\/i> (deucravacitinib)<\/b><\/p>\n

\nSotyktu<\/i> (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<\/i> to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Sotyktu<\/i> 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<\/i> selectively inhibits TYK2 at physiologically relevant concentrations. At therapeutic doses, Sotyktu<\/i> does not inhibit JAK1, JAK2 or JAK3.<\/p>\n

\nSotyktu<\/i> is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis.<\/p>\n

\nBristol Myers Squibb: Pursuing Bold Science in Immunology to Transform Patients\u2019 Lives<\/b><\/p>\n

\nBristol Myers Squibb is inspired by a single vision \u2014 transforming patients\u2019 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, healthcare providers and researchers inform our patient-centric approach as we aim to break efficacy ceilings and deliver what matters most \u2014 the promise of living a better life.<\/p>\n

\nSOTYKTU U.S. INDICATION<\/b><\/p>\n

\nSOTYKTU\u00ae<\/sup> (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.<\/p>\n

\nLimitations of Use:<\/p>\n

\nSOTYKTU is not recommended for use in combination with other potent immunosuppressants.<\/p>\n

\nIMPORTANT SAFETY INFORMATION<\/b><\/p>\n

\nCONTRAINDICATIONS<\/b><\/p>\n

\nSOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.<\/p>\n

\nWARNINGS AND PRECAUTIONS<\/b><\/p>\n

\nHypersensitivity:<\/b> Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.<\/p>\n

\nInfections:<\/b> SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:<\/p>\n