Bristol Myers Squibb (BMS) has shared positive top-line results from two late-stage studies of its oral TYK2 inhibitor Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA).
The phase 3 POETYK PsA-1 trial evaluated the drug in patients who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD naïve), while POETYK PsA-2 enrolled those who were bDMARD naïve or had previously received TNFα inhibitor treatment.
More than eight million people in the US are living with psoriasis, an immune-mediated disease that causes inflammation in the body, and up to 30% will develop PsA, which is characterised by joint pain, stiffness and swelling.
Both trials met their primary endpoint, with a significantly greater proportion of Sotyktu-treated patients achieving at least a 20% improvement in the signs and symptoms of the disease compared to placebo after 16 weeks of treatment.
Important secondary endpoints across PsA disease activity at week 16 were also met in both trials, BMS said, adding that the overall safety profile of Sotyktu with the established safety profile of the drug.
Roland Chen, senior vice president and head, immunology, cardiovascular and neuroscience development, BMS, said the findings “demonstrate that oral Sotyktu has the potential to be the first TYK2 inhibitor for people living with PsA”.
“We are encouraged by the positive data across both phase 3 trials and look forward to discussing the results with health authorities,” he said.
Sotyktu is already approved in major markets to treat certain patients with moderate-to-severe plaque psoriasis after being shown in late-stage trials to improve skin clearance, symptom burden and quality of life.
BMS also recently shared positive results from the phase 3b/4 PSORIATYK SCALP study of Sotyktu in moderate-to-severe scalp psoriasis.
The data presented at the 2024 European Academy of Dermatology and Venereology Congress in September showed that more than three times as many patients achieved a scalp-specific Physician’s Global Assessment response of zero or one (clear/almost clear) at week 16 compared to those on placebo, at 48.5% versus 13.7%, respectively.
A significantly higher percentage of Sotyktu-treated patients also achieved at least a 90% improvement in Psoriasis Scalp Severity Index response and a change from baseline in scalp-specific itch compared with placebo.