Bristol Myers Squibb has announced encouraging findings from two key Phase 3 trials, POETYK PsA-1 and POETYK PsA-2, evaluating deucravacitinib in adults with psoriatic arthritis (PsA).
Our take: There are no comparative studies with already established products, which could restrict the uptake of new therapy.
The studies demonstrated that patients receiving deucravacitinib showed significantly greater improvements compared to those given a placebo after 16 weeks of treatment, achieving at least a 20% reduction in symptoms and disease markers (ACR20 response).
Key Trial Outcomes
Both trials successfully reached their primary objective, with a notable percentage of patients treated with deucravacitinib achieving ACR20 response at Week 16. Additionally, important secondary goals related to disease activity were met, underscoring the overall effectiveness of the treatment. The safety profile observed during the trials aligned with previous findings from earlier studies in psoriatic arthritis and moderate-to-severe plaque psoriasis.
Overview of the Phase 3 Program
The deucravacitinib Phase 3 program for psoriatic arthritis comprises two large-scale, randomized, double-blind trials conducted across multiple centers. The trials focus on adults with active psoriatic arthritis, assessing the safety and efficacy of the treatment.
POETYK PsA-1 included approximately 670 participants with active PsA who had not received prior biologic therapies for the condition. POETYK PsA-2 involved around 730 patients, including those who were either biologic-naïve or had previously been treated with TNFα inhibitors.
The trials span a 52-week period, starting with a 16-week placebo-controlled phase, followed by continued treatment through Week 52. A safety comparison arm using apremilast was part of POETYK PsA-2.
Trial Objectives and Endpoints
The primary aim of both studies was to measure the percentage of participants achieving an ACR20 response by Week 16. Additional assessments were conducted to evaluate various aspects of disease activity. Participants completing the full 52 weeks of treatment may have the opportunity to join an open-label extension phase for continued monitoring and treatment.
Deucravacitinib is an oral therapy that selectively inhibits tyrosine kinase 2 (TYK2) through a unique mechanism of action, distinguishing it from other treatments. As the first TYK2 inhibitor under clinical investigation for several immune-related diseases, deucravacitinib represents a novel class of small-molecule drugs.
The promising results from these trials highlight deucravacitinib’s potential as an effective and safe option for managing psoriatic arthritis, offering hope for improved outcomes in patients with this chronic condition.
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