Bristol Myers Squibb’s deucravacitinib (Sotyktu) has shown superior efficacy to placebo in treating psoriatic arthritis (PsA), meeting the American College of Rheumatology 20 (ACR20) response endpoint in two pivotal Phase 3 trials. The studies, POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), achieved their primary endpoints after 16 weeks of treatment, indicating significant potential for the oral therapy in managing PsA.
Dr. Roland Chen, Senior Vice President at Bristol Myers Squibb, emphasized the significance of the results, noting that PsA is a complex disease with symptoms ranging from joint pain to skin lesions. Despite existing treatments, there remains a demand for safer and more effective oral options. “The positive outcomes from both POETYK PsA-1 and POETYK PsA-2 studies suggest that oral Sotyktu could become the first TYK2 inhibitor for PsA patients, supporting its potential in addressing this unmet need,” Chen said in a statement.
In addition to the primary endpoint success, the trials also met key secondary endpoints, demonstrating improvement in PsA disease activity at Week 16. Safety results over the 16-week treatment period were consistent with previous clinical data for deucravacitinib, as observed in Phase 2 PsA and Phase 3 plaque psoriasis trials.
Both trials were multicenter, randomized, double-blind, placebo-controlled studies involving adults with active PsA. POETYK PsA-1 enrolled around 670 patients who were biologic disease-modifying antirheumatic drug (bDMARD) naive, while POETYK PsA-2 included approximately 730 patients, some of whom had prior exposure to TNFα inhibitors. Both trials spanned 52 weeks, with an initial placebo-controlled phase through Week 16, followed by an open-label extension from Week 16 to Week 52. The POETYK PsA-2 trial also included a reference arm using apremilast for safety comparisons.
Deucravacitinib, already FDA-approved under the brand name Sotyktu for moderate-to-severe plaque psoriasis (PsO), has shown sustained clinical benefit in long-term use. Recent data also highlighted the treatment’s safety profile over a 3-year period, with continuous therapy maintaining a consistent incidence rate of adverse events (AEs). Among 1,519 participants who received at least one dose of deucravacitinib, 513 continued treatment through the long-term extension phase. Adverse events, including COVID-19 and upper respiratory infections, were generally consistent, with some decreases in rates of treatment discontinuations and serious adverse events (SAEs) between the 1-year and 3-year marks.
The long-term findings further underscore the durability and safety of deucravacitinib as a treatment for plaque psoriasis and potentially for psoriatic arthritis. As Bristol Myers Squibb reviews these promising Phase 3 results, the company anticipates further discussions with health authorities regarding the drug’s approval for PsA.
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