Deucravacitinib demonstrated a statistically significant inhibition of radiographic progression compared to placebo.
Positive results have been announced from a phase 3 clinical trial evaluating the efficacy and safety of deucravacitinib (Sotyktu) for the treatment of active psoriatic arthritis (PsA) in adult patients who are naïve to biologic disease-modifying anti-rheumatic medications, Bristol Myers Squibb announced in a release.1
Deucravacitinib Shows Joint, Skin Symptom Improvements in Psoriatic Arthritis / and.one - stock.adobe.com
Results from the POETYK PsA-1 (NCT04908202) trial showed that deucravacitinib met its primary endpoint of proportion of patients meeting the American College of Rheumatology improvement of 20% (ACR20) response. The safety profile of the therapy was also seen to be consistent with previous studies.
“Psoriatic arthritis can be a complex, multifaceted and heterogeneous disease, underscoring the significant need to equip healthcare providers with new safe and effective oral treatment options,” Philip Mease, MD, director of rheumatology research at Providence Swedish Medical Center, said in a release.1 “Improvements in joint and skin symptoms, as well as quality of life, are important treatment goals, and the results demonstrated in this phase 3 study across these parameters highlight the potential of Sotyktu as a new way of treating this debilitating disease.”
POETYK PsA-1 is a randomized, double-blind, placebo-controlled phase 3 trial evaluating the efficacy and safety of deucravacitinib compared to placebo in adult patients with PsA who are naïve to biologic disease-modifying anti-rheumatic medications. The study cohort included 670 patients who were diagnosed with PsA of at least a 3 month duration and have active plaque psoriatic skin lesions or a documented medical history of plaque psoriasis.
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The study found that 54.2% of patients who received deucravacitinib achieved ACR20 response at week 16, compared to 34.1% of patients who received placebo. The therapy also met several key secondary endpoints in the trial, including Psoriasis Area and Severity Index 75 response, Health Assessment Questionnaire-Disability Index score, 36-Item Short Form Survey Physical Component Summary score and Minimal Disease Activity response.
In a post hoc analysis deucravacitinib demonstrated a statistically significant inhibition of radiographic progression compared to placebo. Additionally, a significantly greater proportion of patients who received the therapy did not have radiographic progression. The most frequent adverse event in both groups was upper respiratory tract infection.
The data from POETYK PsA-1 is being presented at the European Alliance of Associations for Rheumatology Congress, being held in Barcelona, Spain, from June 11 to 14.
“These positive phase 3 data build on the strong results from our POETYK Phase 3 PsA-2 trial and underscore the potential of Sotyktu as an oral, first-in-class TYK2 inhibitor for people living with psoriatic arthritis,” Dennis Grasela, PharmD, PhD, vice president and senior global program lead of Immunology and Cardiovascular at Bristol Myers Squibb, said in a release.1 “The potential of Sotyktu for this chronic, progressive disease exemplifies our commitment to the pursuit of transformative medicines for rheumatic conditions.”
READ MORE: Dermatology Resource Center
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