Bristol Myers Squibb  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).

$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.

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“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).

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“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 approachas 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.

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Source- businesswire