Bristol Myers Squibb Presents Sotyktu (deucravacitinib) Data Showing Durable Efficacy, Consistent Safety in Adults with Psoriatic Arthritis Over Two Years
Results from the POETYK PsA-2 open-label extension demonstrated robust response rates in patients treated with Sotyktu, with clinical responses continuing to improve through year one and maintained through year two
Two-year data build on the proven efficacy and safety profile of Sotyktu as the only approved tyrosine kinase 2 (TYK2) inhibitor for adults with psoriatic arthritis
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced positive results through two years of treatment from the Phase 3 POETYK PsA-2 study, including its open-label extension (OLE), showing durable efficacy and a consistent safety profile for Sotyktu (deucravacitinib) in adults with active psoriatic arthritis. These data are being presented at the Congress of Clinical Rheumatology – West (CCR-West) in Huntington Beach, California, taking place September 17-20, 2026.
Among patients who entered the OLE, Sotyktu demonstrated durable efficacy, with clinical responses continuing to improve from Week 16 through Week 52 and maintained through Week 104. Responses were robust across key clinical efficacy measures, including American College of Rheumatology (ACR) 20/50/70 and Minimal Disease Activity (MDA), both for patients who received Sotyktu continuously from the start of the Phase 3 study through the OLE and patients who switched from placebo to Sotyktu at Week 16 and continued Sotyktu through the remainder of the Phase 3 study and OLE.
Among patients who received Sotyktu continuously from the beginning of the Phase 3 study through the OLE, ACR 20/50/70 response rates at Week 104 were 76.2%, 52.6% and 34.6%, respectively, based on observed analysis, and 65.3%, 44.9% and 29.4%, respectively, using nonresponder imputation (NRI). MDA response rates were 51.2% (observed) and 43.7% (NRI).
Additionally, among patients who switched from placebo to Sotyktu at Week 16 and continued treatment through the OLE, ACR 20/50/70 response rates at Week 104 were 76.9%, 54.6% and 37.7% (observed), and 69.3%, 49.2% and 33.9% (NRI), respectively. MDA response rates for those who switched to Sotyktu were 48.7% (observed) and 43.7% (NRI).
“Psoriatic arthritis is a complex, chronic and often debilitating disease that can affect any part of the body, leaving patients in need of treatment options that can support symptom control beyond the initial months of therapy,” 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. “These longer-term results strengthen the evidence supporting Sotyktu as a durable oral option for managing key joint and skin manifestations, with a favorable safety profile.”
Results also showed that Sotyktu was well-tolerated through Week 104. Safety outcomes were consistent with the previously reported PsA-2 study results through 52 weeks and with the established long-term Sotyktu safety profile observed in the five-year psoriasis clinical program, with no new safety signals identified. In patients with any Sotyktu exposure through the two-year cumulative period, adverse events (AEs) occurred in 86.6% of 604 patients, serious AEs in 12.6% of patients and AEs leading to discontinuation in 7.6% of patients. The most common AEs were upper respiratory tract infection, nasopharyngitis and COVID-19.
“Following the approval of Sotyktu for adults with active psoriatic arthritis earlier this year, these results through two years of treatment in POETYK PsA-2 reinforce the durable efficacy and safety profile observed across our clinical program and the various subgroups assessed,” said Liz Colston, MD, PhD, vice president and head of Immunology development, Bristol Myers Squibb. “These positive data add to our understanding of Sotyktu in psoriatic arthritis and reinforce our confidence in its potential role in helping address the needs of people living with chronic rheumatic diseases.”
Bristol Myers Squibb thanks the patients, investigators and clinical trial sites participating in the OLE of the POETYK PsA-2 study. Results from the OLE of the POETYK PsA-1 study will also be presented at an upcoming medical meeting.
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 go on to develop PsA. In addition to impairments in physical function, pain and fatigue caused by PsA, the disease can significantly impact the well-being of patients. Patients with PsA are also at increased risk of serious comorbidities.
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 included 670 patients with active PsA who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD naïve). POETYK PsA-2 included 729 patients with active PsA who were bDMARD naïve or had previously received TNFα inhibitor treatment. Patients met the CASPAR criteria for PsA, with at least three swollen and three tender joints and had an active or documented history of plaque psoriasis. Both trials included 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. Key secondary endpoints were also assessed at Week 16 across measures of PsA disease activity.
Patients in both trials completing 52 weeks of treatment were potentially eligible to enroll in open-label extensions (OLEs) receiving Sotyktu at 6 mg once daily through Week 156.
Overall, 729 patients were randomized in POETYK PsA-2 (312 in the continuous Sotyktu group, 312 in the placebo-to-Sotyktu group and 105 in the apremilast-to-Sotyktu group), of which 245, 254 and 70 patients, respectively, entered the optional OLE. Efficacy outcomes were evaluated in patients who consented to enter the OLE and included American College of Rheumatology (ACR) 20%/50%/70% improvement in response (ACR 20/50/70) and minimal disease activity (MDA) at Weeks 16, 52 and 104. Data were reported as observed and with imputation for missing data. Safety was evaluated through Week 104 in all patients who received ≥ 1 dose of Sotyktu 6 mg in the first year (including placebo crossovers), capturing events from the first dose up to 30 days post-last dose or data cutoff.
About 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 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 selectivity inhibits TYK2 at physiologically relevant concentrations. At therapeutic doses, Sotyktu does not inhibit JAK1, JAK2 or JAK3.
Sotyktu is approved in the United States and numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis.
Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients’ Lives
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. Combining our patient-centric approach and deep understanding of the immune system that spans over 20 years of experience, we continue to pursue bold science to deliver life-changing medicines that elevate new standards of care across rheumatology, dermatology and pulmonology. Through our sequential immunotherapy research framework, which 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, we strive to bring forward tailored approaches, treatments and combinations that may lead to durable remissions, improved quality of life and functional cures.
Sotyktu U.S. Indications and Important Safety Information
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 Reactions: 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 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 SOTYKTU prior to initiating treatment 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. Patients who develop a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated, and be closely monitored. 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. In the 16-week placebo-controlled period of Trials PSO-1 and PSO-2, 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. The clinical implications of SOTYKTU on viral hepatitis reactivation are 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 trials of PSO-1 and PSO-2, 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 during 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 treatment with 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. Treatment with SOTYKTU has been associated with liver enzyme elevation. Evaluate liver enzymes at baseline and during treatment with SOTYKTU in patients with known or suspected liver disease according to routine management. If 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, complete 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.
Hypoglycemia, including severe hypoglycemia, has been reported following initiation of JAK inhibitors in patients with diabetes. Advise diabetic patients to notify their healthcare provider(s) if they develop signs or symptoms of hypoglycemia.
ADVERSE REACTIONS
Most common adverse reactions in patients with plaque psoriasis (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.
The overall safety profile of SOTYKTU observed in patients with active psoriatic arthritis was generally consistent with the safety profile observed in patients with plaque psoriasis.
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.
INDICATIONS
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.
SOTYKTU® is indicated for the treatment of active psoriatic arthritis in adults.
Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.
SOTYKTU and the SOTYKTU logo are trademarks of Bristol Myers Squibb Company.
© 2026 Bristol Myers Squibb Company
About Bristol Myers Squibb: Transforming Patients’ Lives Through Science
At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.
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 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 results of future post-marketing studies will be consistent with the results of this study, that Sotyktu (deucravacitinib), for the indications described in this release may not be commercially successful, any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of Sotyktu for such indications may be contingent upon verification and description of clinical benefit in additional confirmatory trials. 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, 2025, 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.
corporatefinancial-news
View source version on businesswire.com: https://www.businesswire.com/news/home/20260915494041/en/
Bristol Myers Squibb
Media Inquiries:
[email protected]
Investors:
[email protected]
KEYWORDS: California New Jersey United States North America
INDUSTRY KEYWORDS: Health Clinical Trials Research Pharmaceutical Science Biotechnology
MEDIA:
| Logo |
 |