PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE:BMY) today announced Week 52 data from the pivotal Phase 3 POETYK PsA-1 trial further confirming 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 company also announced new findings from an integrated analysis of the Phase 2 PAISLEY-SLE and PAISLEY long-term extension (LTE) studies supporting the safety and efficacy with up to four years of Sotyktu treatment for moderate-to-severe systemic lupus erythematosus (SLE).
Today at #ACR25, $BMY announced two late-breaking abstracts for an investigational medicine from a Phase 3 trial in #PsoriaticArthritis and a long-term extension for a Phase 2 trial in systemic lupus erythematosus (#SLE).
These data will be presented as late-breaking abstracts (POETYK PsA-1 abstract #LB20 and PAISLEY abstract #LB10) at the American College of Rheumatology (ACR) Convergence in Chicago, Illinois taking place from October 24-29, 2025.
“The POETYK PsA-1 Week 52 data and PAISLEY LTE findings reinforce our confidence in Sotyktu for rheumatic conditions and underscore our commitment to addressing unmet needs and the pursuit of bold science that may elevate new standards of care in Immunology,” said Dennis Grasela, vice president and senior global program lead, Immunology and Cardiovascular, Bristol Myers Squibb. “We are eager to continue our discussions on psoriatic arthritis with global health authorities as we seek to add this indication to the approved label around the world. Meanwhile, we are excited about progressing our Phase 3 trials in systemic lupus erythematosus, which represent an important part of our robust portfolio in lupus investigating multiple disease pathways.”
New Week 52 data from pivotal Phase 3 POETYK PsA-1 trial reinforce efficacy and safety of Sotyktu for PsA
New data showed ACR20 responses (at least a 20 percent improvement in signs and symptoms of disease) achieved at Week 16 (Sotyktu, 54.2%; placebo, 34.1%; p<0.0001) continued to improve and were maintained for patients receiving continuous Sotyktu treatment through Week 52 (63.1%). Patients who switched from placebo to Sotyktu at Week 16 also had a similar ACR20 response at Week 52 (60.8%), consistent with findings from the POETYK PsA-2 trial. The overall safety profile of Sotyktu through Week 52 was consistent with that established across the Sotyktu development program, including through Week 52 of the Phase 3 POETYK PsA-2 clinical trial.
“Psoriatic arthritis is a heterogeneous disease that affects patients in diverse and often debilitating ways, and there remains a clear need for oral therapies that can address both joint and skin symptoms,” 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 compelling results build on the previously disclosed data, showing that Sotyktu delivered meaningful improvements across key domains of psoriatic arthritis disease activity with a consistent safety profile, supporting the potential for Sotyktu as a new, first-line, advanced, oral option for patients living with psoriatic arthritis.”
Inhibition of progression of structural joint damage was observed at Week 16 and sustained through Week 52, as measured by the mean change from baseline in the modified Sharp-van der Heijde score. Further, a higher proportion of patients saw no progression of joint damage with Sotyktu treatment compared with placebo at Week 16 (Sotyktu, 82.0%; placebo, 71.5%) and at Week 52 (Sotyktu to Sotyktu, 73.3%; placebo to Sotyktu, 66.5%), based on post hoc analysis.
Additionally, 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, which continued to improve after Week 16 and were maintained through Week 52. Responses at Week 52 were comparable in patients who switched from placebo to Sotyktu at Week 16. Similar trends for ACR50 and ACR70 were observed compared with ACR20.
No new safety signals were identified through Week 52 in the POETYK PsA-1 trial. The most frequent adverse event (AE) was upper respiratory infection. Few serious AEs and AEs that led to discontinuation occurred. No new safety signals related to adjudicated major adverse cardiovascular events, venous thromboembolism or opportunistic infections were observed.
Initial Week 16 results from PsA-1 were disclosed at the 2025 European Alliance of Associations for Rheumatology (EULAR) Congress. Initial results from the POETYK PsA-2 trial were presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting, with Week 52 data from this trial also presented at EULAR 2025. Regulatory applications for Sotyktu for the treatment of adults with active PsA are currently under review in the U.S., Europe, Japan and China. The U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.
Phase 2 PAISLEY-SLE and PAISLEY LTE studies demonstrated consistent safety and effectiveness with Sotyktu for moderate-to-severe SLE
Integrated analyses of the Phase 2 PAISLEY-SLE and PAISLEY LTE studies showed that Sotyktu maintained a consistent safety profile and durable efficacy in patients with moderate-to-severe SLE with up to four years of drug exposure, with no new safety signals, despite complex background therapies.
Response rates were maintained over time, as measured by SLE Responder Index-4 (SRI-4), British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA), Lupus Low Disease Activity State (LLDAS) and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-50).
“New systemic treatments for lupus are urgently needed since as many as half of patients do not attain treatment goals in response to current treatment options and no new oral therapy has been approved in decades,” said Eric F. Morand, MD, PhD, head of Rheumatology, Monash University, Australia. “These results are important for physicians, as they represent the longest follow-up of a TYK2 inhibitor in systemic lupus erythematosus to date, supporting this approach as a novel oral therapy with the potential to maintain both efficacy and a favorable safety profile over extended periods of time.”
By Week 72, patients initially assigned to the placebo group in the PAISLEY-SLE study who transitioned to Sotyktu during the PAISLEY LTE study achieved improvements comparable to those seen in patients who received continuous Sotyktu treatment. Serious AEs occurred in 17.0%, 14.9% and 21.8% of patients who received Sotyktu 3 mg twice daily (BID), 6 mg BID and 12 mg once daily (QD), respectively. Additionally, AEs leading to treatment discontinuation occurred in 13.4%, 11.4% and 17.3%, respectively.
Initial findings from the Phase 2 PAISLEY-SLE trial were disclosed at the 2022 EULAR Congress.
Bristol Myers Squibb is also presenting findings at ACR Convergence that support its larger portfolio in lupus, including Phase 1 data for the company’s CD19-targeted CAR T cell therapy (BMS-986353) in severe, refractory SLE (abstract #1529), as well as Phase 1 data for this asset in systemic sclerosis (abstract #0843) and idiopathic inflammatory myopathies (abstract #LB14).
Bristol Myers Squibb thanks the patients, investigators and clinical trial sites who participated in these studies.
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. 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.
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 the Phase 2 PAISLEY-SLE and PAISLEY LTE Studies
PAISLEY-SLE was a one-year, randomized, double-blind, placebo-controlled, global Phase 2 trial. More information can be found at www.clinicaltrials.gov (NCT03252587).
Eligible patients had a systemic lupus erythematosus (SLE) diagnosis for at least 24 weeks before screening, met the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria, were seropositive and had a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 and ≥1 British Isles Lupus Assessment Group (BILAG) index A or ≥2 BILAG B manifestations, at least one of which had to be from the musculoskeletal or mucocutaneous domain. Patients on standard background medications were randomized 1:1:1:1 to oral deucravacitinib 3 mg twice daily (BID), 6 mg BID, 12 mg once daily (QD) or placebo BID. Of 363 patients randomized, 275 (76.0%) completed 48 weeks of treatment (deucravacitinib 3 mg BID, 71/91 [78%]; 6 mg BID, 76/93 [82%]; 12 mg QD, 62/89 [70%]; placebo, 66/90 [73%]). The primary endpoint was the proportion of patients achieving SLE Responder Index-4 (SRI-4) at Week 32 by non-responder imputation (NRI). Secondary endpoints included SRI-4, BILAG-based Composite Lupus Assessment (BICLA), Lupus Low Disease Activity State (LLDAS), decrease of ≥50% from baseline Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity score (CLASI-A) and change from baseline in active (tender and swollen) joint response at Week 48.
Following the Phase 2 PAISLEY-SLE trial, patients had the option to enroll in the PAISLEY long-term extension (LTE) trial (NCT03920267) and receive 3 mg BID, 6 mg BID or 12 mg QD deucravacitinib. A total of 261 patients enrolled in the LTE study, with a total of 151 patients completing the study. Databases of the parent and LTE studies were integrated for analyses of safety through Week 226 and efficacy through Week 222. Efficacy analyses using composite measures of disease activity were summarized descriptively without formal statistical comparisons. For binary endpoints, 95% confidence intervals were obtained using the Clopper-Pearson method.
About Lupus
Lupus is a chronic, complex immune-mediated disease that results in the immune system attacking multiple organs in the body. Lupus most often affects the skin, joints, kidneys, blood vessels, blood cells, brain and lungs, causing widespread inflammation and tissue damage in the affected organ(s). There are more than five million people around the world with a form of lupus, and it is most often diagnosed in young women between the ages of 15 and 44.
The most common type of lupus is systemic lupus erythematosus (SLE), which accounts for approximately 70 percent of all lupus cases, is a chronic autoimmune disorder known for its clinical heterogeneity and multisystem involvement that disproportionally impacts women of childbearing age and individuals of African and Asian ancestry. Within five years of disease onset, 40-60 percent of patients with SLE develop lupus nephritis (renal involvement), the most important predictor of SLE morbidity and mortality. Despite recent advances in the development of biologic medicines, an unmet need remains for novel therapies that can effectively reduce disease activity, reduce the need for steroids, prevent flares and organ damage, improve quality of life and control symptoms.
About Sotyktu (deucravacitinib)
Sotyktu 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 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: Pioneering Paths Forward 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 U.S. Indications and Important Safety Information
INDICATION
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 (≥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.
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.
Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.
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 future study results may not be consistent with the results to date and that Sotyktu (deucravacitinib) may not achieve its primary study endpoints or receive regulatory approval for the indications 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 indications 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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