Bristol Myers Squibb Presents Late-Breaking Data from Phase 3 POETYK PsA-2 Trial Demonstrating Superiority of Sotyktu (deucravacitinib) Compared with Placebo in Adults with Psoriatic Arthritis
Bristol Myers Squibb (NYSE:BMY) announced positive results from its Phase 3 POETYK PsA-2 trial evaluating Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). The trial met its primary endpoint, with 54.2% of Sotyktu-treated patients achieving ACR20 response compared to 39.4% for placebo at Week 16 (p=0.0002).
Key secondary endpoints were also met, including significant improvements in PASI 75 response and Health Assessment Questionnaire-Disability Index (HAQ-DI) scores (-0.32 vs -0.21 for placebo, p=0.0013). The safety profile remained consistent with previous trials, with adverse events reported in 62.8% of Sotyktu patients versus 54.7% for placebo and 73.3% for apremilast.
Sotyktu, as the first TYK2 inhibitor for PsA, demonstrates potential in addressing both joint and skin symptoms. The drug is already approved in multiple countries for moderate-to-severe plaque psoriasis treatment.
Bristol Myers Squibb (NYSE:BMY) ha annunciato risultati positivi dal suo studio di Fase 3 POETYK PsA-2 che valuta Sotyktu (deucravacitinib) negli adulti con artrite psoriasica attiva (PsA). Lo studio ha raggiunto il suo obiettivo primario, con il 54,2% dei pazienti trattati con Sotyktu che ha ottenuto una risposta ACR20 rispetto al 39,4% del placebo alla settimana 16 (p=0,0002).
Gli obiettivi secondari chiave sono stati anch'essi raggiunti, inclusi miglioramenti significativi nella risposta PASI 75 e nei punteggi dell'Health Assessment Questionnaire-Disability Index (HAQ-DI) (-0,32 rispetto a -0,21 per il placebo, p=0,0013). Il profilo di sicurezza è rimasto coerente con studi precedenti, con eventi avversi riportati nel 62,8% dei pazienti trattati con Sotyktu rispetto al 54,7% del placebo e al 73,3% per apremilast.
Sotyktu, come primo inibitore TYK2 per PsA, dimostra potenziale nell'affrontare sia i sintomi articolari che quelli cutanei. Il farmaco è già approvato in diversi paesi per il trattamento della psoriasi a placche moderata-severa.
Bristol Myers Squibb (NYSE:BMY) anunció resultados positivos de su ensayo de Fase 3 POETYK PsA-2 que evalúa Sotyktu (deucravacitinib) en adultos con artritis psoriásica activa (PsA). El ensayo cumplió su objetivo primario, con el 54,2% de los pacientes tratados con Sotyktu logrando una respuesta ACR20 en comparación con el 39,4% para el placebo a la semana 16 (p=0,0002).
También se cumplieron los objetivos secundarios clave, incluidos mejoras significativas en la respuesta PASI 75 y en los puntajes del Health Assessment Questionnaire-Disability Index (HAQ-DI) (-0,32 frente a -0,21 para el placebo, p=0,0013). El perfil de seguridad se mantuvo consistente con ensayos anteriores, con eventos adversos reportados en el 62,8% de los pacientes tratados con Sotyktu frente al 54,7% para el placebo y al 73,3% para apremilast.
Sotyktu, como el primer inhibidor de TYK2 para PsA, demuestra potencial para abordar tanto los síntomas articulares como los cutáneos. El fármaco ya está aprobado en varios países para el tratamiento de la psoriasis en placas de moderada a severa.
브리스톨 마이어스 스퀴브 (NYSE:BMY)는 소티크투 (데우크라바시티닙)의 3상 POETYK PsA-2 시험에서 긍정적인 결과를 발표했습니다. 이 시험은 활성 건선 관절염(PsA)을 앓고 있는 성인을 평가하는 것이며, 소티크투 치료를 받은 환자의 54.2%가 ACR20 반응을 달성했습니다, 이는 위약의 39.4%와 비교됩니다 (p=0.0002).
주요 2차 목표 또한 달성되었으며, PASI 75 반응 및 건강 평가 설문지-장애 지수(HAQ-DI) 점수에서 유의미한 개선이 있었습니다 (-0.32 대 -0.21, 위약의 경우, p=0.0013). 안전성 프로필은 이전 시험과 일관되었으며, 소티크투 환자의 62.8%에서 이상 반응이 보고되었고, 위약은 54.7%, 아프레밀라스트는 73.3%였습니다.
소티크투는 PsA를 위한 첫 번째 TYK2 억제제로서 관절 및 피부 증상을 모두 해결할 수 있는 잠재력을 보여줍니다. 이 약물은 이미 여러 국가에서 중등도에서 중증의 판상 건선 치료를 위해 승인되었습니다.
Bristol Myers Squibb (NYSE:BMY) a annoncé des résultats positifs de son essai de phase 3 POETYK PsA-2 évaluant Sotyktu (deucravacitinib) chez des adultes atteints d'arthrite psoriasique active (PsA). L'essai a atteint son objectif principal, avec 54,2% des patients traités par Sotyktu atteignant une réponse ACR20 contre 39,4% pour le placebo à la semaine 16 (p=0,0002).
Des objectifs secondaires clés ont également été atteints, y compris des améliorations significatives dans la réponse PASI 75 et les scores de l'Health Assessment Questionnaire-Disability Index (HAQ-DI) (-0,32 contre -0,21 pour le placebo, p=0,0013). Le profil de sécurité est resté cohérent avec les essais précédents, avec des événements indésirables rapportés chez 62,8% des patients traités par Sotyktu contre 54,7% pour le placebo et 73,3% pour l'aprémilast.
Sotyktu, en tant que premier inhibiteur de TYK2 pour la PsA, démontre un potentiel pour traiter à la fois les symptômes articulaires et cutanés. Le médicament est déjà approuvé dans plusieurs pays pour le traitement du psoriasis en plaques modéré à sévère.
Bristol Myers Squibb (NYSE:BMY) hat positive Ergebnisse aus seiner Phase-3-Studie POETYK PsA-2 veröffentlicht, die Sotyktu (Deucravacitinib) bei Erwachsenen mit aktiver Psoriasis-Arthritis (PsA) bewertet. Die Studie erreichte ihr primäres Ziel, wobei 54,2% der mit Sotyktu behandelten Patienten eine ACR20-Antwort erzielten im Vergleich zu 39,4% für das Placebo in Woche 16 (p=0,0002).
Wichtige sekundäre Endpunkte wurden ebenfalls erreicht, einschließlich signifikanter Verbesserungen in der PASI 75-Antwort und den Werten des Health Assessment Questionnaire-Disability Index (HAQ-DI) (-0,32 gegenüber -0,21 für das Placebo, p=0,0013). Das Sicherheitsprofil blieb konsistent mit früheren Studien, wobei unerwünschte Ereignisse bei 62,8% der Sotyktu-Patienten im Vergleich zu 54,7% für Placebo und 73,3% für Apremilast berichtet wurden.
Sotyktu, als erster TYK2-Inhibitor für PsA, zeigt Potenzial, sowohl Gelenk- als auch Hautsymptome zu behandeln. Das Medikament ist bereits in mehreren Ländern zur Behandlung von moderater bis schwerer Plaque-Psoriasis zugelassen.
- Met primary endpoint with significantly higher ACR20 response vs placebo (54.2% vs 39.4%)
- Achieved significant improvements in secondary endpoints (PASI 75 and HAQ-DI scores)
- Lower discontinuation rate vs apremilast (2.2% vs 10.5%)
- First TYK2 inhibitor showing efficacy in both joint and skin symptoms
- Higher adverse event rate compared to placebo (62.8% vs 54.7%)
- Higher serious adverse events vs placebo (1.9% vs 1.0%)
Insights
Bristol Myers Squibb's positive Phase 3 POETYK PsA-2 trial results for Sotyktu represent a significant clinical milestone that substantially strengthens the company's immunology portfolio. The drug, already approved for plaque psoriasis, demonstrated 54.2% ACR20 response compared to 39.4% for placebo (p=0.0002) - meeting its primary endpoint with compelling statistical significance.
This successful trial positions BMY to potentially expand Sotyktu's label into the lucrative psoriatic arthritis market, representing a substantial commercial opportunity. With approximately 2.5 million Americans affected by psoriatic arthritis, this indication could meaningfully boost Sotyktu's revenue potential beyond its current psoriasis approval.
The favorable safety profile is particularly noteworthy, with discontinuation rates of just 2.2% for Sotyktu versus 10.5% for competitor apremilast. This differentiated tolerability profile provides BMY with compelling competitive positioning against established oral therapies.
As the first potential TYK2 inhibitor for psoriatic arthritis, Sotyktu would enter a market currently dominated by injectable biologics and JAK inhibitors with more concerning safety profiles. A well-tolerated oral option addresses a clear unmet need and could capture significant market share from both existing therapies and newly diagnosed patients.
The POETYK PsA-2 trial results demonstrate Sotyktu's capability to address the complex, heterogeneous nature of psoriatic arthritis that affects both joints and skin. By achieving statistical significance in ACR20 responses and PASI 75 metrics, Sotyktu effectively targets both the rheumatological and dermatological manifestations of this challenging disease.
Particularly impressive is Sotyktu's improvement in patient-reported outcomes via the Health Assessment Questionnaire-Disability Index (HAQ-DI), with a -0.32 point change versus -0.21 for placebo (p=0.0013). This meaningful functional improvement addresses a critical aspect of treatment success - enhancing patients' daily quality of life.
The safety profile appears advantageous compared to apremilast, with notably lower discontinuation rates (2.2% vs 10.5%) and fewer adverse events (62.8% vs 73.3%). This tolerability advantage, combined with the convenience of oral administration, positions Sotyktu favorably against existing treatment options.
As the first TYK2 inhibitor potentially entering the psoriatic arthritis treatment landscape, Sotyktu represents a mechanistically novel approach. Unlike JAK inhibitors that have faced regulatory scrutiny over safety concerns, Sotyktu's selective TYK2 inhibition offers a potentially more targeted approach that could minimize systemic immunosuppression while maintaining efficacy across multiple disease domains.
Significantly more patients treated with Sotyktu achieved ACR and PASI response rates and had greater improvements in patient-reported quality of life compared with placebo at Week 16
Sotyktu was well-tolerated in comparison with placebo and apremilast, demonstrating safety consistent with its established clinical profile
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
“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,
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
“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 program 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.
About the Sotyktu Phase 3 Psoriatic Arthritis Trial Program
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 TNFα 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.
About Psoriatic Arthritis
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.
About Sotyktu (deucravacitinib)
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 signaling 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: Pursuing Bold Science in Immunology to Transform Patients’ Lives
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, healthcare providers and researchers inform our patient-centric approach as we aim to break efficacy ceilings and deliver what matters most — the promise of living a better life.
SOTYKTU
SOTYKTU® (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Limitations of Use:
SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.
Infections: 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:
- with chronic or recurrent infection
- who have been exposed to tuberculosis
- with a history of a serious or an opportunistic infection
- with underlying conditions that may predispose them to infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated.
Viral Reactivation
Herpes virus reactivation (e.g., herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multidermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.
Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.
Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU.
Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo.
Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.
Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.
Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, postmarketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.
ADVERSE REACTIONS
Most common adverse reactions (≥
SPECIFIC POPULATIONS
Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.
Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.
Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment.
SOTYKTU is available in 6 mg tablets.
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About 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. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.
Otezla® (apremilast) is a registered trademark of Amgen Inc.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that Sotyktu (deucravacitinib) may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether Sotyktu for such indication will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2024, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
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FAQ
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