Loading ...

user Admin_Adham
12th Mar, 2025 12:00 AM
Test

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.

TOP PICKS FOR YOU


Share This Article

Comments

Leave a comment