Bristol Myers Squibb Reports Sustained Efficacy of Sotyktu in Psoriatic Arthritis and Lupus Through Extended Follow-up
核心洞察
Bristol Myers Squibb (搜索) announced 52-week data from the Phase 3 POETYK PsA-1 trial showing Sotyktu maintained ACR20 responses of 63.1% in psoriatic arthritis (搜索) patients, with consistent safety profile.
Integrated analysis of Phase 2 PAISLEY studies demonstrated sustained efficacy and safety of Sotyktu in systemic lupus erythematosus (搜索) patients with up to four years of treatment exposure.
The TYK2 (搜索) inhibitor showed inhibition of structural joint damage progression in psoriatic arthritis (搜索), with 73.3% of patients experiencing no joint damage progression at Week 52.
Bristol Myers Squibb (搜索) announced compelling long-term data for Sotyktu (deucravacitinib) demonstrating sustained efficacy and consistent safety across two immune-mediated diseases. The company presented Week 52 results from the pivotal Phase 3 POETYK PsA-1 trial in psoriatic arthritis (搜索) and integrated analyses from Phase 2 PAISLEY studies in systemic lupus erythematosus (搜索), with data to be presented at the American College of Rheumatology Convergence in Chicago from October 24-29, 2025.
Sustained Clinical Response in Psoriatic Arthritis
The POETYK PsA-1 trial demonstrated that ACR20 responses achieved at Week 16 (Sotyktu 54.2% versus placebo 34.1%, p<0.0001) continued to improve and were maintained through Week 52, reaching 63.1% in patients receiving continuous Sotyktu treatment. Patients who switched from placebo to Sotyktu at Week 16 achieved similar ACR20 response rates of 60.8% at Week 52, consistent with findings from the POETYK PsA-2 trial.
"Psoriatic arthritis (搜索) 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. "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."
The trial enrolled approximately 670 patients with active psoriatic arthritis (搜索) who were not previously treated with a biologic disease-modifying antirheumatic drug. The study design included a 52-week treatment period with placebo-controlled treatment through Week 16, followed by reallocation and continued active treatment from Week 16 to Week 52.
Protection Against Structural Joint Damage
A key finding was the inhibition of progression of structural joint damage, 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. Post hoc analysis revealed that a higher proportion of patients experienced no progression of joint damage with Sotyktu treatment compared with placebo at Week 16 (Sotyktu 82.0% versus placebo 71.5%) and at Week 52 (Sotyktu to Sotyktu 73.3% versus placebo to Sotyktu 66.5%).
Patients treated with Sotyktu demonstrated improvements across a wide range of clinical measures of disease activity, patient-reported outcomes, and extra-articular manifestations of psoriatic arthritis (搜索), which continued to improve after Week 16 and were maintained through Week 52. Similar trends for ACR50 and ACR70 responses were observed compared with ACR20.
Four-Year Safety and Efficacy Data in Lupus
The integrated analyses of the Phase 2 PAISLEY-SLE and PAISLEY long-term extension studies showed that Sotyktu maintained a consistent safety profile and durable efficacy in patients with moderate-to-severe systemic lupus erythematosus (搜索) with up to four years of drug exposure. Response rates were maintained over time across multiple efficacy measures, including SLE Responder Index-4 (SRI-4), British Isles Lupus (搜索) 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 (搜索) 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 at Monash University, Australia. "These results are important for physicians, as they represent the longest follow-up of a TYK2 (搜索) inhibitor in systemic lupus erythematosus (搜索) to date."
The PAISLEY-SLE study enrolled 363 patients who were randomized to oral deucravacitinib 3 mg twice daily, 6 mg twice daily, 12 mg once daily, or placebo twice daily. Of these patients, 275 (76.0%) completed 48 weeks of treatment. By Week 72, patients initially assigned to placebo who transitioned to Sotyktu during the long-term extension achieved improvements comparable to those seen in patients who received continuous Sotyktu treatment.
Safety Profile Remains Consistent
No new safety signals were identified through Week 52 in the POETYK PsA-1 trial. The most frequent adverse event was upper respiratory infection, with few serious adverse events and events leading to discontinuation. No new safety signals related to adjudicated major adverse cardiovascular events, venous thromboembolism, or opportunistic infections were observed.
In the lupus (搜索) studies, serious adverse events occurred in 17.0%, 14.9%, and 21.8% of patients who received Sotyktu 3 mg twice daily, 6 mg twice daily, and 12 mg once daily, respectively. Adverse events leading to treatment discontinuation occurred in 13.4%, 11.4%, and 17.3%, respectively.
Regulatory Progress and Clinical Significance
Regulatory applications for Sotyktu for the treatment of adults with active psoriatic arthritis (搜索) are currently under review in the United States, 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.
"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," said Dennis Grasela, vice president and senior global program lead, Immunology and Cardiovascular at Bristol Myers Squibb (搜索). "We are eager to continue our discussions on psoriatic arthritis (搜索) with global health authorities as we seek to add this indication to the approved label around the world."
Sotyktu is an oral, selective tyrosine kinase 2 (搜索) (TYK2 (搜索)) inhibitor that represents a new class of small molecules. It is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases, designed to selectively target TYK2 and inhibit signaling of interleukin-23 (搜索), IL-12 (搜索), and Type 1 interferons. The drug is currently approved in numerous countries for the treatment of adults with moderate-to-severe plaque psoriasis (搜索).