Deucravacitinib Meets Endpoints in Phase 3 PsA Trial

TOPLINE:

Deucravacitinib (Sotyktu) demonstrated efficacy in treating patients with active psoriatic arthritis (PsA), achieving higher American College of Rheumatology (ACR) 20 response rates (ie, ≥ 20% improvement in disease signs and symptoms) than placebo at week 16, with a consistent overall safety profile.

METHODOLOGY:

• Deucravacitinib, an oral selective allosteric tyrosine kinase 2 inhibitor, represents a new class of small molecules designed to target immune-mediated diseases.
• The phase 3 multicenter, randomized POETYK PsA-2 trial conducted by Bristol Myers Squibb evaluated the efficacy and safety of deucravacitinib in approximately 730 adults with active PsA aged 18 years or older.
• Patients in the trial were either naive to treatment with a biologic disease–modifying antirheumatic drug or previously had been treated with tumor necrosis factor alpha inhibitors.
• The trial included a 52-week treatment period, with a placebo-controlled phase through week 16, followed by reallocation and continued active treatment. It also included an apremilast safety reference arm.
• The primary endpoint was the proportion of participants achieving an ACR20 response at week 16, and secondary endpoints encompassed various measures of PsA disease activity.

TAKEAWAY:

• The trial met the primary endpoint, with 54.2% of patients treated with deucravacitinib vs 39.4% of patients treated with placebo achieving an ACR20 response (P = .0002).
• At week 16, deucravacitinib treatment demonstrated improvements in clinical signs, symptoms, extra-articular manifestations, and patient-reported outcomes. A higher percentage of patients treated with deucravacitinib achieved a psoriasis area and severity index 75 response than those treated with placebo.
• Compared with placebo, deucravacitinib led to significant improvements in the patient-reported health assessment questionnaire–disability index (P = .0013).
• The safety profile of deucravacitinib was consistent with what has been reported in previous trials, and no new safety signals were identified. Adverse events were reported in 62.8%, 54.7%, and 73.3% patients in the deucravacitinib group, placebo group, and apremilast group, respectively.

IN PRACTICE:

“These results are particularly encouraging because they support the potential for Sotyktu to impact both joint and skin symptoms, as well as patient-reported quality of life outcomes,” Philip Mease, MD, director of rheumatology research at Swedish Medical Center/Providence St. Joseph Health and clinical professor at the University of Washington School of Medicine, Seattle, said in a news release.

SOURCE:

This study was conducted by Bristol Myers Squibb.

LIMITATIONS:

The press release announcing the trial’s results did not discuss any limitations.

DISCLOSURES:

This study was sponsored by Bristol Myers Squibb.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.