Bristol-Myers Squibb Co. (BMY) has reported encouraging topline results from two crucial Phase 3 trials assessing Sotyktu (deucravacitinib) for adults with active psoriatic arthritis (PsA).
The Phase 3 Sotyktu PsA study comprises two multicenter, randomized, double-blind, placebo-controlled trials to evaluate both the efficacy and safety for individuals aged 18 and over with active PsA.
Notably, both the POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055) trials successfully achieved their primary endpoint, defined as the proportion of participants reaching an ACR20 response by Week 16. In these trials, a notably higher percentage of patients treated with Sotyktu attained an ACR20 response, indicating at least a 20% improvement in disease signs and symptoms, after 16 weeks compared to those receiving a placebo.
Furthermore, both trials reached significant secondary endpoints related to PsA disease activity by Week 16. Bristol-Myers Squibb highlighted that Sotyktu's overall safety profile through 16 weeks aligns with the established safety observed in earlier Phase 2 PsA and Phase 3 moderate-to-severe plaque psoriasis trials.
The company plans to collaborate with principal investigators to unveil detailed findings at forthcoming medical conferences. Patients completing 52 weeks of treatment in both trials might be eligible to join an open-label extension study.
Roland Chen, Senior Vice President and Head of Immunology, Cardiovascular, and Neuroscience Development at Bristol-Myers Squibb, stated, "Psoriatic arthritis presents as a complex condition causing various symptoms including joint pain, swelling, and psoriatic skin lesions. Although existing therapies are available, rheumatologists continue to seek a safe and effective oral treatment. The results from POETYK PsA-1 and POETYK PsA-2 demonstrate that oral Sotyktu could potentially be the first TYK2 inhibitor for those suffering from psoriatic arthritis..."
These topline results mark the first Phase 3 clinical trials for Sotyktu in a rheumatic condition, highlighting the drug's potential. Sotyktu is already approved in numerous countries for treating adults with moderate-to-severe plaque psoriasis.
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