Bristol Myers Squibb Announces Breakthrough Phase 3 Data for Deucravacitinib in Active Psoriatic Arthritis

June 12,Bristol-Myers Squibb announced positive results from the pivotal Phase 3 trial POETYK PsA-1 (IM011-054). The trial aimed to evaluateDeucravacitinib in the treatment of adult patients with active psoriatic arthritis who have not previously received biologic disease-modifying antirheumatic drugs (bDMARDs)Efficacy and safety in China. The trial met the primary endpoint, namelyAt week 16 of treatment, the proportion of patients in the deucravacitinib treatment group achieving ACR20 (at least 20% improvement in disease signs and symptoms) was significantly higher than in the placebo group (54.2% vs. 34.1%, respectively).During the 16-week treatment period, the safety profile of deucravacitinib was consistent with the results observed in its previous clinical trial program, including the Phase 3 POETYK PsA-2 trial and the Phase 3 clinical trial for moderate to severe plaque psoriasis.

Deucravacitinib is aAn oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, it is also a representative of a new class of small molecule drugs and is currently undergoing clinical trials for various immune-mediated diseases. Scientists at Bristol-Myers Squibb designed deucravacitinib toSelective targeting of TYK2, thereby inhibiting the signaling of IL-23, IL-12, and Type I interferons (IFN), which are key cytokines involved in the pathogenesis of various immune-mediated diseases.Deucravacitinib achieves high selectivity by binding to the regulatory domain of TYK2, leading to allosteric inhibition of TYK2 and its downstream functions. Within physiological concentration ranges, deucravacitinib selectively inhibits TYK2. At therapeutic doses, deucravacitinib does not inhibit JAK1, JAK2, or JAK3. Deucravacitinib has been approved in multiple countries and regions worldwide for the treatment of...Adult Moderate to Severe Plaque PsoriasisPatient.

POETYK PsA-1 Trial Data to Be Presented as a Late-Breaking Abstract at the European Alliance of Associations for Rheumatology (EULAR) Annual Congress, Held in Barcelona, Spain, from June 11 to 14, 2025. According to a Bristol-Myers Squibb press release,Improving joint and skin symptoms and enhancing quality of life are the core treatment goals for psoriatic arthritis. The results of this Phase 3 trial on these key indicators demonstrate the potential of deucravacitinib as an innovative therapy for this disabling disease.。

At Week 16 of treatment, patients in the deucravacitinib treatment group showed improvements in multiple clinical measures of disease activity, patient-reported outcomes, and extra-articular manifestations. Notably, the trial also met several key secondary endpoints, including: PASI 75 (75% improvement in Psoriasis Area and Severity Index) response rate, Health Assessment Questionnaire-Disability Index (HAQ-DI) score, Short Form-36 Physical Component Summary (SF-36 PCS), and Minimal Disease Activity (MDA) response rate. Additionally, increases in ACR50 (at least 50% improvement in signs and symptoms of disease) and ACR70 (at least 70% improvement in signs and symptoms of disease) response rates were observed. Nominal significant differences were also seen in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score, Disease Activity Score 28-C-Reactive Protein (DAS28-CRP), and the resolution of dactylitis in a pooled analysis.

Moreover, in post-hoc analyses, an inhibitory effect of deucravacitinib on radiographic progression was observed at Week 16. Although the pre-specified analysis did not show a statistically significant difference between the deucravacitinib group and the placebo group in the mean change from baseline (CfB) in the modified Sharp/van der Heijde (mSvdH) score, post-hoc analyses indicated a statistically significant difference between treatment groups. Additionally, compared with the placebo group, a significantly higher proportion of patients in the deucravacitinib group achieved no radiographic progression (defined as mSvdH score CfB ≤ 0 at Week 16).

No new safety signals were identified in the POETYK PsA-1 trial. The most common adverse event in both the deucravacitinib group and the placebo group was upper respiratory tract infection (5.1% vs. 3.0%, respectively). At week 16 of treatment, the incidence of serious adverse events (1.8% vs. 2.4%, respectively) and adverse events leading to discontinuation (2.4% vs. 1.8%, respectively) was low in both groups.

These positive Phase 3 data further solidify the robust results of the POETYK PsA-2 trial.The latest data from the pivotal Phase 3 trial POETYK PsA-2 will also be presented at this meeting. The trial evaluated the efficacy of deucravacitinib in treating patients with active psoriatic arthritis. These patients were either biologic disease-modifying antirheumatic drug (bDMARD)-naïve or had previously received tumor necrosis factor-alpha (TNF-α) inhibitor therapy. The results showed,At week 16 of treatment, deucravacitinib demonstrated superior efficacy compared to placebo. Furthermore, by week 52, patients who continued or switched to deucravacitinib showed sustained improvement in clinical response, with those continuously receiving deucravacitinib maintaining stable efficacy.。

At week 16, 54.2% of patients receiving deucravacitinib achieved an ACR20 response, compared with 39.4% of patients receiving placebo (p=0.0002). By week 52, 62.2% of patients continuing on deucravacitinib achieved an ACR20 response; among patients who switched from placebo to deucravacitinib after week 16, this proportion reached 67.3%.Similar trends were observed in ACR50 and ACR70 response rates. Additionally, compared with placebo, the deucravacitinib treatment group maintained stability in key secondary endpoints by Week 52, including: PASI 75 response rate, MDA response rate, HAQ-DI score, and SF-36 PCS score. During the period up to Week 52, deucravacitinib was well-tolerated, with a safety profile consistent with its previous trial results in psoriatic arthritis and psoriasis.

Bristol-Myers Squibb will collaborate with principal investigators to present more data from the POETYK PsA Phase 3 trial program at an upcoming medical conference.