Bristol-Myers Squibb (BMS) recently announced that the pivotal Phase 3 POETYK PSO-1 study evaluating the novel anti-inflammatory drug deucravacitinib (BMS-986165) for the treatment of psoriasis met its co-primary endpoint and several key secondary endpoints.
Deucravacitinib is the first and only novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor in clinical trials evaluating the treatment of a variety of immune-mediated diseases. TYK2 is an intracellular signaling kinase that mediates the signaling of IL-23, IL-12, and type I IFN; these cytokines are natural cytokines involved in inflammatory and immune responses.
POETYK PSO-1 was the first pivotal Phase 3 study evaluating the efficacy and safety of deucravacitinib, assessing a once-daily dose of 6 mg deucravacitinib in patients with moderate to severe plaque psoriasis. Results showed that the study met its co-primary endpoint: after 16 weeks of treatment, compared with the placebo group, a higher proportion of patients in the 6 mg deucravacitinib treatment group had a psoriasis area and severity index improvement of at least 75% from baseline (PASI75) and a static physician global assessment (sPGA) score of complete or near-complete clearance of lesions (sPGA 0/1).
Furthermore, the study met several key secondary endpoints, including: the deucravacitinib treatment group was superior to the Otezla (apremilast) treatment group in terms of the proportion of patients achieving PASI75 remission and sPGA 0/1 at week 16. The overall safety profile of deucravacitinib in this study was consistent with previously reported phase 2 study results.
Bristol-Myers Squibb and the principal investigators will complete a full evaluation of the POETYK PSO-1 study data and share detailed results at a future medical conference.
POETYK PSO-1 is the first of two global Phase 3 studies evaluating the safety and efficacy of deucravacitinib in patients with moderate to severe plaque psoriasis compared to placebo and Otezla. Results from the second study, POETYK PSO-2, are expected in the first quarter of 2021. In addition to psoriasis, deucravacitinib is being investigated in a wide range of immune-mediated diseases, and Bristol-Myers Squibb will present results from the Phase 2 Psoriatic Arthritis trial at the American College of Rheumatology (ACR) Convergence 2020, November 5-9, 2020.
Currently, moderate to severe plaque psoriasis remains undertreated, and many patients continue to suffer from poor disease control. There is a significant medical need in this field for effective, convenient, and life-affirming treatment options.
