Today, we are delving into the POETYK PsA-2 trial, a phase III clinical trial investigating Bristol Myers Squibb’s Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). Sotyktu is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, representing a novel class of small molecules. It is the first selective TYK2 inhibitor in clinical trials across various immune-mediated diseases. Sotyktu was FDA approved on September 9, 2022, for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

The Phase 3 POETYK clinical trials in PsA were presented as a late-breaking abstract at the American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida, which took place from March 7-11, 2025. The results revealed that the trial successfully met its primary endpoint, with a significantly greater proportion of Sotyktu-treated patients achieving an ACR20 response (at least a 20 percent improvement in signs and symptoms of the disease) compared with the placebo at Week 16 (54.2% versus 39.4%, respectively; p=0.0002). The overall safety profile of Sotyktu throughout 16 weeks of treatment remained consistent with that established in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials.

Here is a brief overview of the study:

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

Study Details | Source

  • Sponsor: Bristol-Myers Squibb
  • The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.
  • Interventions:
    • Drug: Deucravacitinib
    • Other: Placebo
  • Primary Outcomes Measures:
    • Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR 20) response
      • Time Frame - At week 16

In the POETYK PsA-2 trial, no new safety signals were identified. This data is promising as a potential treatment for rheumatic conditions. We eagerly anticipate Bristol Myers Squibb collaborating with key investigators to present additional data from the Phase 3 POETYK PsA program at upcoming medical congresses this year.

We highly value your input and welcome any thoughts or insights you may have on this topic. Additionally, we encourage you to sign up for alerts to stay informed on the latest published guidelines and articles. Thank you for your continued support and engagement in advancing medical research and treatment options.

Copyright © 2025 Guideline Central, all rights reserved.