Bristol Myers Squibb has announced positive results from a Phase 3 clinical trial evaluating the efficacy and safety of deucravacitinib (Sotyktu) for treating active psoriatic arthritis (PsA) in adults who have not previously received biologic disease-modifying anti-rheumatic drugs (DMARDs).
The POETYK PsA-1 trial (NCT04908202) showed that deucravacitinib successfully met its primary endpoint. More than 54% of patients receiving the treatment achieved a 20% improvement in their psoriatic arthritis symptoms (ACR20) by week 16. This was significantly higher than the 34.1% of patients who received the placebo. The treatment’s safety profile was also consistent with previous studies.
Dr. Philip Mease, director of rheumatology research at Providence Swedish Medical Center, commented on the results, highlighting the complex nature of psoriatic arthritis and the ongoing need for new, safe, and effective oral treatments. “Improving joint and skin symptoms, as well as quality of life, are key treatment goals,” he said. “These results emphasize Sotyktu’s potential as a new approach to managing this debilitating disease.”
The study, which was randomized, double-blind, and placebo-controlled, enrolled 670 patients with active psoriatic arthritis and plaque psoriasis. These patients had been diagnosed for at least three months and had active plaque psoriatic skin lesions.
Alongside the primary ACR20 endpoint, the trial met several key secondary endpoints. Patients treated with deucravacitinib showed significant improvements in skin symptoms, as measured by the Psoriasis Area and Severity Index (PASI 75), as well as improved physical function and quality of life, as shown by the Health Assessment Questionnaire-Disability Index and the 36-Item Short Form Survey Physical Component Summary.
In a post-hoc analysis, deucravacitinib was shown to significantly reduce radiographic progression compared to the placebo. A higher proportion of patients on deucravacitinib did not show radiographic progression. The most common side effect observed in both groups was an upper respiratory tract infection.
The findings from the POETYK PsA-1 trial are being presented at the 2025 European Alliance of Associations for Rheumatology Congress in Barcelona, Spain, from June 11 to 14.
“These encouraging Phase 3 results, along with positive findings from the POETYK PsA-2 trial, highlight the potential of Sotyktu as a first-in-class oral TYK2 inhibitor for people with psoriatic arthritis,” said Dennis Grasela, PharmD, PhD, vice president and senior global program lead of Immunology and Cardiovascular at Bristol Myers Squibb. “This marks an important step in our commitment to developing transformative medicines for rheumatic conditions.”
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