U.S. FDA Approves Bristol Myers Squibb's Sotyktu® (deucravacitinib) for the Treatment of Adults with Active Psoriatic Arthritis
Significantly more patients treated with once-daily, oral Sotyktu achieved an ACR20 response compared with placebo at Week 16 in the pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 clinical trials
Sotyktu is the first and only tyrosine kinase 2 (TYK2) inhibitor to be approved for this indication
Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Sotyktu® (deucravacitinib) for the treatment of adults with active psoriatic arthritis (PsA).1 Sotyktu, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, is the first TYK2 inhibitor to be approved for PsA.
"Today's announcement marks the introduction of a new, differentiated option to treat adults with active psoriatic arthritis," said Al Reba, senior vice president, Cardiovascular & Immunology Commercialization, Bristol Myers Squibb. "This latest approval of Sotyktu confirms its important role in managing both skin and joint symptoms of psoriatic disease and is a key milestone as we continue to explore its development in diseases that have limited or no treatment options."
This FDA approval is based on positive results from the pivotal POETYK PsA-1 and POETYK PsA-2 trials, which evaluated the efficacy and safety of Sotyktu 6 mg once daily in adults with active psoriatic arthritis. In both trials, treatment with Sotyktu resulted in significant improvement in disease activity, as measured by American College of Rheumatology (ACR) 20 (the primary endpoint) and Minimal Disease Activity (MDA) response (key secondary endpoint).
Efficacy Results at Week 16 in Adults with Psoriatic Arthritis (NRIa)1
|
PsA-1 |
PsA-2 |
||||
Endpoint |
Sotyktu (N=336) |
Placebo (N=334) |
Difference from Placebo (95% CI) |
Sotyktu (N=312) |
Placebo (N=312) |
Difference from Placebo (95% CI) |
ACR20 response, % |
54b |
34 |
20(12, 27) |
54b |
39 |
15 (7, 23) |
ACR50 response, % |
24 |
14 |
11 (5, 17) |
29 |
16 |
13 (6, 19) |
ACR70 response, % |
12 |
5 |
6 (2, 10) |
10 |
5 |
5 (1, 9) |
Minimal disease activity response, % |
19c* |
10 |
9 (4, 14) |
26c† |
15 |
11 (5, 17) |
American College of Rheumatology >20% (or >50% or >70%) improvement) |
||||||
| ACR50 and ACR70 were additional endpoints. Additional endpoints were not adjusted for multiplicity; therefore, statistical significance has not been established. | ||||||
| N is number of randomized and treated subjects | ||||||
| * Statistically significant from placebo (p=0.0012) | ||||||
| † Statistically significant from placebo (p=0.0007) | ||||||
| a NRI = Non-Responder Imputation | ||||||
| b Multiplicity-controlled p<0.0002, Sotyktu vs. placebo comparison | ||||||
| c Minimal disease activity (MDA) = 5 out of 7 outcomes: tender joint count <1; swollen joint count <1; Psoriasis Activity and Severity Index <1 or body surface area <3; patient pain visual analogue scale (VAS) <15; patient global disease activity VAS <20; Health Assessment Questionnaire Disability Index <0.5; tender entheseal points <1 | ||||||
The overall safety profile of Sotyktu observed in individuals with active psoriatic arthritis was generally consistent with the safety profile in those with plaque psoriasis. Most common adverse reactions (≥1% in Sotyktu and greater than placebo) are: upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis, and acne. Sotyktu is associated with the following warnings and precautions: hypersensitivity reactions, infections, tuberculosis, malignancy including lymphomas, rhabdomyolysis and elevated CPK, laboratory abnormalities, immunizations, and potential risks related to JAK inhibition.1
"Psoriatic arthritis is a chronic, progressive autoimmune condition that often involves both the joints and skin. Patients often have trouble moving and staying active and can experience pain in the joints, and tendons, or ligaments,"2-4 said Philip J. Mease, MD, director of rheumatology research, Providence Swedish Medical Center, and clinical professor, University of Washington School of Medicine. "New oral, effective first-line treatments are needed. In clinical trials, health-related quality of life was assessed by the 36-Item Short Form Health Survey (SF-36). Patients treated with Sotyktu showed improvements in SF-36 Physical Component Summary (PCS) score at Week 16 compared to placebo (key secondary endpoint).1 There were also improvements in all four SF-36 PCS domain scale scores: physical functioning, role-physical, bodily-pain, and general health.1 By aiding in symptom management, Sotyktu could make a meaningful difference for patients."
"The psoriatic disease community has been waiting for an additional oral treatment to address the debilitating joint and skin symptoms of this disease," said Steven Taylor, President & Chief Executive Officer of the Arthritis Foundation. "We welcome this new treatment option for people living with psoriatic arthritis."
The FDA first approved Sotyktu in 2022 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sotyktu is not recommended for use with other potent immunosuppressants in this population. Since then, multiple global regulatory authorities have approved Sotyktu for that indication. Sotyktu has five years of clinical efficacy and safety data in patients with moderate-to-severe plaque psoriasis.
Today's approval of Sotyktu in psoriatic arthritis is a tangible demonstration of Bristol Myers Squibb's commitment to develop medicines that help fill unmet needs in the treatment landscape.
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.2 Up to 30 percent of patients with psoriasis go on to develop PsA.5 In addition to impairments in physical function, pain and fatigue caused by PsA, the disease can significantly impact the well-being of patients.6 Patients with PsA are also at increased risk of serious comorbidities.
About the Sotyktu Phase 3 Psoriatic Arthritis Trial Program
The Phase 3 Sotyktu PsA program includes two Phase 3, multicenter, randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety of Sotyktu 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 624 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 3 swollen and 3 tender joints and had an active or documented history of plaque psoriasis. 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. 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 through 156 weeks.7,8
About Sotyktu® (deucravacitinib)
Sotyktu is an oral, selective, tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action. It is the first selective TYK2 inhibitor in clinical studies across moderate-to-severe plaque psoriasis and active psoriatic arthritis.9 Bristol Myers Squibb scientists designed Sotyktu to selectively target TYK2, thereby mediating the signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of plaque psoriasis and psoriatic arthritis. Sotyktu achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and mediation of its downstream functions. Sotyktu has been shown to have high selectivity for TYK2 at physiologically relevant concentrations and has not been shown to inhibit JAK1, JAK2 or JAK3 in in vitro assays.9 The precise mechanism linking inhibition of TYK2 enzyme to therapeutic effectiveness is not currently known.
Sotyktu is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis.10-12
The efficacy and safety of Sotyktu in patients with moderate-to-severe plaque psoriasis were evaluated in POETYK PSO-1 and POETYK PSO-2, multi-national, randomized, double-blind, placebo- and active comparator-controlled 52-week Phase 3 studies. In total, 664 patients were enrolled in POETYK PSO-1, and 1,020 patients were enrolled in POETYK PSO-2. All participants had moderate-to-severe plaque psoriasis and were candidates for phototherapy or systemic therapy.
IMPORTANT SAFETY INFORMATION
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.
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. 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 serious infection occurs. 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 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.
ADVERSE REACTIONS
Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) in patients with plaque psoriasis 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.
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
1787-US-2500540 03/26
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.
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, whether Sotyktu (deucravacitinib) for the additional indication described in this release will be commercially successful, any marketing approvals, if granted, may have significant limitations on their use and that continued approval of Sotyktu for such indication may be contingent upon verification and description of clinical benefit in 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.
References
1 SOTYKTU Prescribing Information. SOTYKTU U.S. Product Information. March 2026. Princeton, N.J.: Bristol Myers Squibb Company.
2 American College of Rheumatology. "Psoriatic Arthritis." https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed October 5, 2020.
3 Cleveland Clinic. Psoriatic arthritis. Cleveland Clinic. Accessed December 10, 2025. https://my.clevelandclinic.org/health/diseases/13286-psoriatic-arthritis
4 National Psoriasis Foundation. About psoriatic arthritis. National Psoriasis Foundation. Accessed December 10, 2025. https://www.psoriasis.org/about-psoriatic-arthritis/#overview
5 Mease P, Gladman D, Papp K, et al. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. Journal of the American Academy of Dermatology. 2013;69(5). doi: 10.1016/j.jaad.2013.07.023.
6 Dures E, Bowen C, Brooke M, et al. Diagnosis and initial management in psoriatic arthritis: a qualitative study with patients. Rheumatology Advances in Practice. 2019;3(2) https://doi.org/10.1093/rap/rkz022.
7 van der Heidje D, Mease P, Paul C, et al. Efficacy and Safety of Deucravacitinib up to Week 52: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study in Patients With Active Psoriatic Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs. Presented at the American College of Rheumatology (ACR) Convergence; October 24-29, 2025.
8 Mease P, Chandran V, Armstrong A, et al. Efficacy and safety of deucravacitinib up to week 52 from POETYK PsA-2: a multicenter, randomized, double-blind, placebo-controlled, phase 3 study in patients with psoriatic arthritis. Presented at the European Congress of Rheumatology; June 11-14, 2025.
9 Chimalakonda A, Burke J, Cheng L, et al. Selectivity Profile of the Tyrosine Kinase 2 Inhibitor Deucravacitinib Compared with Janus Kinase 1/2/3 Inhibitors. Dermatol Ther (Heidelb). 2021;11(5):1763-1776. doi:10.1007/s13555-021-00596-8
10 Bristol Myers Squibb. The world's first oral TYK2 allosteric inhibitor, Sotyktu® (deucravacitinib tablets), has been approved in China. Press release. October 20, 2023. https://www.bms.com/cn/media/press-release-listing/10202023.html
11 Bristol Myers Squibb. TYK2 inhibitor Sotyktu® Received manufacturing and marketing approval for 6 mg tablets. Press release. September 26, 2022. https://www.bms.com/jp/media/press-release-listing/press-release-listing-2022/20220926.html
12 Bristol Myers Squibb. New treatment for adults with plaque psoriasis arrives in Mexico. Press release. February 18, 2025. https://www.bms.com/mx/media/press-release-listing/bristolmyerssquibbampliasucompromisodelargadataconlainvestigaciondelcanceratravesdecontinente2continente4cancer2.html
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