Bristol Myers Squibb Reports Two-Year Data Showing Durable Sotyktu Efficacy in Psoriatic Arthritis
Bristol Myers Squibb (NYSE: BMY) announced positive two-year results from the Phase 3 POETYK PsA-2 study and its open-label extension (OLE), providing additional evidence of durable efficacy and a consistent safety profile for Sotyktu® (deucravacitinib) in adults living with active psoriatic arthritis (PsA). The findings are being presented at the Congress of Clinical Rheumatology – West (CCR-West), held September 17–20, 2026, in Huntington Beach, California.
The latest results extend the clinical evidence for Sotyktu beyond the initial 52-week treatment period and show that improvements in key measures of PsA disease activity continued through one year and were maintained through two years of treatment. The data include patients who received Sotyktu continuously from the beginning of the Phase 3 study as well as patients who initially received placebo and switched to Sotyktu at Week 16.
Psoriatic arthritis is a chronic inflammatory disease that can affect the joints, skin and other parts of the body. Because disease activity can vary over time and may affect multiple domains, long-term treatment can require sustained control of symptoms and inflammation. The two-year POETYK PsA-2 findings provide additional information on the durability of Sotyktu responses across several clinically important measures.
Durable Responses Observed Through Two Years
Among patients who entered the open-label extension, Sotyktu demonstrated continued clinical activity from Week 16 through Week 52, with responses maintained through Week 104.
The study evaluated several measures of treatment response, including American College of Rheumatology (ACR) 20, ACR 50 and ACR 70 responses, as well as Minimal Disease Activity (MDA). These endpoints assess different levels of improvement in disease activity and help characterize the depth and breadth of response to treatment.
Patients who received Sotyktu continuously from the beginning of the Phase 3 study through the OLE demonstrated robust response rates at Week 104.
Based on observed analysis, 76.2% of these patients achieved an ACR 20 response at Week 104. ACR 50 and ACR 70 response rates were 52.6% and 34.6%, respectively. When nonresponder imputation (NRI) was used, the corresponding response rates were 65.3% for ACR 20, 44.9% for ACR 50 and 29.4% for ACR 70.
The MDA response rate at Week 104 was 51.2% using observed analysis and 43.7% using NRI.
These results indicate that treatment responses were sustained over the two-year evaluation period, including higher levels of clinical improvement represented by ACR 50 and ACR 70 and the more comprehensive MDA measure.
Patients Switching From Placebo Also Showed Sustained Responses
The POETYK PsA-2 OLE also evaluated patients who initially received placebo and switched to Sotyktu at Week 16. These patients continued Sotyktu for the remainder of the Phase 3 study and throughout the open-label extension.
At Week 104, the observed ACR 20 response rate among these patients was 76.9%. ACR 50 and ACR 70 response rates were 54.6% and 37.7%, respectively.
Using NRI, the corresponding response rates were 69.3% for ACR 20, 49.2% for ACR 50 and 33.9% for ACR 70.
For MDA, the response rate at Week 104 was 48.7% based on observed analysis and 43.7% using NRI.
The results in both treatment groups provide information on the durability of clinical responses after patients began Sotyktu treatment. The findings also show that patients who transitioned from placebo to active treatment were able to achieve meaningful responses that were maintained during longer-term follow-up.
Multiple Measures of Psoriatic Arthritis Activity
The ACR response measures used in the study provide different levels of improvement in signs and symptoms of PsA. ACR 20 represents a clinically meaningful level of improvement, while ACR 50 and ACR 70 indicate progressively greater responses.
MDA is another important treatment goal in PsA because it captures disease activity across multiple domains rather than focusing solely on joint symptoms. Achieving MDA can reflect broader control of the disease.
The continued responses across ACR 20, ACR 50, ACR 70 and MDA therefore add to the understanding of Sotyktu’s longer-term performance in active PsA.
The results are particularly relevant in the context of a chronic disease in which patients may require long-term treatment. Maintaining efficacy over an extended period is an important consideration when evaluating therapies for people who may remain on treatment for years.
Safety Profile Remained Consistent Through Week 104
In addition to efficacy, the POETYK PsA-2 OLE provided longer-term safety information for Sotyktu.
Bristol Myers Squibb reported that Sotyktu was well tolerated through Week 104, with safety outcomes consistent with previously reported findings from the PsA-2 study through 52 weeks. The results were also consistent with the established long-term Sotyktu safety profile observed in the company’s five-year psoriasis clinical development program.
No new safety signals were identified during the two-year cumulative treatment period.
Among 604 patients with any Sotyktu exposure during the cumulative two-year period, adverse events occurred in 86.6% of patients. Serious adverse events were reported in 12.6% of patients, while adverse events leading to treatment discontinuation occurred in 7.6%.
The most commonly reported adverse events were upper respiratory tract infection, nasopharyngitis and COVID-19.
The longer-term safety findings provide additional follow-up for clinicians evaluating Sotyktu as a treatment option for patients with active PsA. The consistency between the PsA-2 findings, the longer-term extension data and the established psoriasis safety experience is an important component of the overall clinical development program.
Expert Highlights Need for Long-Term PsA Control
Philip Mease, MD, director of rheumatology research at Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine in Seattle, emphasized the chronic and multifaceted nature of psoriatic arthritis.
According to Mease, PsA can affect different parts of the body and may require treatment strategies capable of providing symptom control beyond the early months of therapy.
He said the longer-term findings strengthen the evidence supporting Sotyktu as a durable oral treatment option for addressing important joint and skin manifestations of the disease, while maintaining a favorable safety profile.
The two-year data are particularly relevant because treatment decisions in chronic inflammatory diseases often involve balancing the need for sustained disease control with considerations around tolerability and treatment burden.
An oral therapy with demonstrated longer-term efficacy could provide another option for patients and physicians seeking to manage active PsA over an extended treatment period.
Building on Sotyktu’s Psoriatic Arthritis Approval
The new data follow the approval of Sotyktu for adults with active psoriatic arthritis earlier in 2026. The latest findings from POETYK PsA-2 add longer-term evidence to the clinical program supporting its use in this population.
Liz Colston, MD, PhD, vice president and head of Immunology Development at Bristol Myers Squibb, said the two-year results reinforce the durable efficacy and safety profile observed throughout the company’s clinical program.
Colston noted that the findings add to the understanding of Sotyktu’s role in PsA and include information across different patient subgroups evaluated during the clinical development program.
The company said the findings reinforce its confidence in the potential role of Sotyktu in addressing the treatment needs of people living with chronic rheumatic diseases.
Continued Development Across Immunology
The POETYK PsA-2 findings form part of Bristol Myers Squibb’s broader development program for Sotyktu in immune-mediated diseases.
The medicine has been studied in psoriasis and psoriatic arthritis, providing the company with clinical experience across inflammatory conditions. The five-year psoriasis clinical program has also contributed to the longer-term safety understanding referenced in the latest PsA-2 findings.
The availability of longer-term data is important as Sotyktu’s use expands into additional patient populations. Two-year efficacy and safety results can provide clinicians with more information about what patients may experience during sustained treatment.
The company also confirmed that results from the open-label extension of the POETYK PsA-1 study are expected to be presented at an upcoming medical meeting. Those findings are expected to provide additional longer-term information from the Sotyktu PsA clinical development program.
Two-Year Findings Add to Clinical Evidence
The POETYK PsA-2 two-year results show that clinical responses to Sotyktu were maintained through Week 104 among patients with active psoriatic arthritis who continued treatment in the open-label extension.
Patients treated continuously with Sotyktu achieved Week 104 observed ACR 20, ACR 50 and ACR 70 response rates of 76.2%, 52.6% and 34.6%, respectively, while MDA was achieved by 51.2%. Using NRI, the corresponding ACR response rates were 65.3%, 44.9% and 29.4%, with an MDA response rate of 43.7%.
Patients who switched from placebo to Sotyktu at Week 16 also demonstrated sustained responses at Week 104. Observed ACR 20, ACR 50 and ACR 70 response rates were 76.9%, 54.6% and 37.7%, respectively, while MDA was achieved by 48.7%. NRI response rates were 69.3%, 49.2% and 33.9% for ACR 20, 50 and 70, respectively, with MDA at 43.7%.
At the same time, no new safety signals were identified through two years of cumulative exposure. The safety findings remained consistent with earlier PsA results and the established long-term Sotyktu experience in psoriasis.
With the Phase 3 POETYK PsA-2 results now extending to two years, Bristol Myers Squibb is adding further evidence on the durability and safety of Sotyktu in active psoriatic arthritis. The findings presented at CCR-West provide longer-term context following the medicine’s approval for adults with active PsA and support continued evaluation of its role as an oral treatment option for people living with this chronic inflammatory disease.
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.