Bristol Myers Squibb Announces New Data on Deucravacitinib in Psoriatic Arthritis and Systemic Lupus Erythematosus

October 29,Bristol-Myers Squibb announced updated data from the pivotal Phase 3 POETYK PsA-1 trial, further confirming the efficacy of deucravacitinib inAdult patients with active psoriatic arthritis (PsA) who have not received biologic disease-modifying antirheumatic drugs (bDMARD) treatmentEfficacy and safety in China.

At the same time, the company also announced the latest findings from the comprehensive analysis of the Phase 2 PAISLEY-SLE trial and the PAISLEY Long-Term Extension (LTE) trial, confirming that deucravacitinib is effective in treatingModerate to Severe Systemic Lupus Erythematosus (SLE)Safety and efficacy over the longest period of 4 years in patients.

These data were presented as the latest breakthrough abstract at the American College of Rheumatology (ACR) Annual Meeting, held from October 24 to 29, 2025.

Critical 3PeriodPOETYK PsA-1Latest Trial52Weekly Data Further Confirms the Efficacy and Safety of Deucravacitinib in the Treatment of Psoriatic Arthritis

Latest data show that 54.2% (vs placebo group 34.1%; p<0.0001) of patients in the deucravacitinib group achieved an ACR20 response (i.e., at least 20% improvement in signs and symptoms of the disease) at week 16; with continued deucravacitinib treatment to week 52, the ACR20 response rate continued to increase and was maintained at 63.1%. Patients who switched from placebo to deucravacitinib at week 16 also achieved a similar ACR20 response rate (60.8%) by week 52, consistent with the results of the POETYK PsA-2 trial. In terms of overall safety, the 52-week safety data for deucravacitinib were consistent with previous research programs, including the 52-week results of the POETYK PsA-2 Phase 3 clinical trial.

Bristol-Myers Squibb's press release stated that psoriatic arthritis is a heterogeneous disease with diverse manifestations, often causing significant distress and impact on patients. There is still an urgent clinical need for oral treatment options that can simultaneously improve joint and skin symptoms.These powerful research results further corroborate the previously released data, showing that deucravacitinib has brought significant improvements in key indicators of disease activity in psoriatic arthritis, with a stable safety profile. It is expected to bring a new advanced first-line oral treatment option for patients with psoriatic arthritis.

Based on the assessment of the mean change from baseline in the modified Sharp-van der Heijde score, the progression of structural joint damage was inhibited at Week 16 and sustained through Week 52. Furthermore, post-hoc analysis showed that a higher proportion of patients treated with deucravacitinib experienced no progression of joint damage compared to placebo: 82.0% in the deucravacitinib group versus 71.5% in the placebo group at Week 16; at Week 52, 73.3% in the deucravacitinib group (i.e., continuously receiving deucravacitinib) and 66.5% in the switch group (i.e., switched from placebo to deucravacitinib).

Moreover, patients who continued to receive deucrabercept treatment showed improvements in multiple clinical indicators of disease activity, patient-reported outcomes, and extra-articular manifestations of psoriatic arthritis. These improvements continued to increase after Week 16 and were sustained through Week 52. For patients who switched from placebo to deucrabercept at Week 16, their responses at Week 52 were comparable to those who had been continuously receiving deucrabercept. Similar trends were observed for ACR50 and ACR70 compared to ACR20.

As of Week 52, no new safety signals were identified in the POETYK PsA-1 study. The most common adverse event was upper respiratory tract infection. Serious adverse events and adverse events leading to discontinuation were infrequent. No new safety signals related to major adverse cardiovascular events/venous thromboembolism/opportunistic infections were observed.

Preliminary results from the POETYK PsA-1 trial at Week 16 were presented at the 2025 European Alliance of Associations for Rheumatology (EULAR) Congress. Preliminary results from the POETYK PsA-2 trial were presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting, with data from Week 52 also showcased at the 2025 EULAR Congress.The registration application for the indication of deucravacitinib in treating adult patients with active psoriatic arthritis is currently under review in the United States, Europe, Japan, and China.The U.S. FDA has provided a PDUFA goal date for this indication, specifically March 6, 2026.

PAISLEY-SLE 2Phase Trial andPAISLEYLong-term extension trials show that deucravacitinib is effective in moderate to severe systemic lupus erythematosus (SLE) Patients have shown sustained and stable safety and efficacy.

The integrated analysis results of the PAISLEY-SLE Phase 2 trial and the PAISLEY long-term extension trial show,Despite the complex background of basic treatment, deucravacitinib has demonstrated durable efficacy and stable safety in the treatment of moderate to severe systemic lupus erythematosus (SLE) patients over a maximum period of four years, with no new safety signals identified.

The response rates of various assessment indicators, including the Systemic Lupus Erythematosus Responder Index-4 (SRI-4), British Isles Lupus Assessment Group Composite Lupus Assessment (BICLA), Lupus Low Disease Activity State (LLDAS), and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-50), remained stable during the follow-up period.

As of Week 72, patients in the PAISLEY-SLE trial who were initially assigned to the placebo group and switched to deucravacitinib treatment during the PAISLEY LTE trial showed improvements comparable to those continuously receiving deucravacitinib. The incidence of serious adverse events (SAEs) was: 17.0% in the deucravacitinib 3 mg twice daily (BID) group, 14.9% in the 6 mg BID group, and 21.8% in the 12 mg once daily (QD) group. Additionally, the rates of discontinuation due to adverse events were 13.4%, 11.4%, and 17.3%, respectively.

Preliminary results of the PAISLEY-SLE Phase 2 trial were presented at the 2022 EULAR Congress.

Bristol-Myers Squibb also presented research findings from its broader lupus erythematosus pipeline at the ACR, including Phase 1 clinical data for a CAR-T cell therapy targeting the CD19 antigen (BMS-986353) in severe, refractory systemic lupus erythematosus (SLE), as well as Phase 1 clinical data for the same product in systemic sclerosis and idiopathic inflammatory myopathies.

Deucravacitinib is an oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, representing a new class of small molecule drugs. Scientists at Bristol-Myers Squibb designed deucravacitinib to selectively target 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 many countries and regions around the world for the treatment of adult patients with moderate to severe plaque psoriasis.

References:
[1] Bristol-Myers Squibb Announces Two Latest Studies Confirming Deucravacitinib Effective for Treating Psoriatic Arthritis and Systemic Lupus Erythematosus. From https://www.prnasia.com/story/509143-1.shtml

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