Phase 3 Deucravacitinib Trial Meets ACR20 End Point in PsA

The pivotal Phase 3 POETYK PsA-1 trial (IM011-054) evaluating deucravacitinib has met its primary endpoint of achieving ACR20 response at week 16 compared to placebo in adults with active psoriatic arthritis (PsA) who were not previously treated with a biologic disease-modifying anti-rheumatic drug (bDMARD).1

These data will be presented at the European Alliance of Associations for Rheumatology (EULAR) Congress in Barcelona, Spain, taking place June 11-14, 2025, by Désirée van der Heijde, MD, PhD, professor of rheumatology at Leiden University, alongside data from POETYK PsA-2 presented by Philip Mease, MD, director of rheumatology research at Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, Seattle.

“PsA can be a complex, multifaceted and heterogeneous disease, underscoring the significant need to equip healthcare providers with new safe and effective oral treatment options,” Mease said in a statement.1 “Improvements in joint and skin symptoms, as well as quality of life, are important treatment goals, and the results demonstrated in this Phase 3 study across these parameters highlights the potential of Sotyktu as a new way of treating this debilitating disease.”

Mease and colleagues found that 54.2% of the deucravacitinib group achieved ACR20 response at week 16 compared to 34.1% of the placebo group (P <.0001), meeting the trial’s primary end point. The trial also met key secondary end points including Psoriasis Area and Severity Index (PASI) 75 response (51.9% vs 7.1%; P <.0001), Health Assessment Questionnaire-Disability Index (HAQ-DI) score (-.39 vs -.22; P <.0001), 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) score (6.06 vs 3.71; P <.0001) and Minimal Disease Activity (MDA) response (19.0% vs 10.2%; P <.0001).

Investigators also observed nominally significant improvements in ACR50 (24.7% vs 13.5%; P = .0002), ACR70 (11.6% vs 5.4%; P = .0039), Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) score (4.6 vs 2.0; P <.0001), 28-Joint Disease Activity Score-C- Reactive Protein (DAS28-CRP) score (-1.33 vs -.83; P <.0001) and dactylitis resolution pooled analysis (57.6% vs 44.1%; P = .01).

Mease and colleagues also observed inhibition of radiographic progression in the deucravacitinib group at Week 16 in post-hoc analyses. More patients in this group also did not have radiographic progression (defined as a change from baseline to Week 16 in modified Sharp-van der Heijde score of less than or equal to 0) compared to those in the placebo group.

POETYK PsA-1 did not identify any new safety signals and the safety profile of deucravacitinib was similar as that in the Phase 3 POETYK PsA-2 trial and the Phase 3 moderate-to-severe plaque psoriasis (PsO) clinical trials. The most frequent adverse event (AE) in both the Sotyktu and placebo arms was upper respiratory tract infection (5.1% versus 3.0%, respectively). Serious AEs (1.8% versus 2.4%, respectively) and AEs that led to discontinuation (2.4% versus 1.8%, respectively) were infrequent though Week 16.

“These positive Phase 3 data build on the strong results from our POETYK Phase 3 PsA- 2 trial and underscore the potential of Sotyktu as an oral, first-in-class TYK2 inhibitor for people living with psoriatic arthritis,” Dennis Grasela, PharmD, PhD, vice president and senior global program lead, Immunology and Cardiovascular, Bristol Myers Squibb, added.1 “The potential of Sotyktu for this chronic, progressive disease exemplifies our commitment to the pursuit of transformative medicines for rheumatic conditions. We look forward to discussing the POETYK PsA-1 and PsA-2 results with global regulatory authorities.”

Bristol Myers Squibb also shared data from the POETYK PsA-2 trial, demonstrating that at Week 16, 54.2% of deucravacitinib-treated patients achieved ACR20 response versus 39.4% of those receiving placebo (P = .0002). At Week 52, 62.2% of patients receiving continuous deucravacitinib treatment and 67.3% of patients who switched from placebo to deucravacitinib after Week 16 achieved ACR20 response. Similar trends were observed for ACR50 and ACR70 and improvements in PASI 75 responses, MDA responses, HAQ-DI scores, and SF-36 PCS scores were maintained compared to placebo at 52 weeks.1

Data from POETYK PsA-2 were previously presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting.2 Bristol Myers Squibb plans to share more detailed results from the POETYK program in future medical meetings.1 Deucravacitinib is approved under the name Sotyktu for treating adults with moderate-to-severe plaque PsO.

REFERENCES

1. Bristol Myers Squibb Presents Late-Breaking Data from Pivotal Phase 3 POETYK PsA-1 Trial Demonstrating Superiority of Sotyktu (deucravacitinib) Compared with Placebo in Adults with Psoriatic Arthritis. News release. Bristol Myers Squibb. June 11, 2025.

2. Thaci D. Efficacy and safety of deucravacitinib in patients with active psoriatic arthritis who are naive to biologic disease-modifying anti-rheumatic drugs or previously received TNF inhibitor treatment.Presented at the 2025 American Academy of Dermatology (ADA) Annual Meeting. Orlando, FL. March 07-11, 2025.