Bristol Myers Squibb Announces Positive Data for Sotyktu in Moderate to Severe Psoriasis
Bristol Myers Squibb (BMS) has announced positive results from a phase 3b/4 study of its oral TYK2 inhibitor Sotyktu (deucravacitinib) in moderate-to-severe scalp psoriasis. The data, presented at this year’s European Academy of Dermatology and Venereology Congress, comes from the ongoing PSORIATYK SCALP trial. This trial included patients with less extensive overall psoriasis.
- Primary Endpoint: The study met its primary endpoint, with 48.5% of patients achieving a scalp-specific Physician’s Global Assessment response of zero or one (clear/almost clear) at week 16, compared to 13.7% on placebo.
- Key Secondary Endpoints: At week 16, a significantly higher percentage of patients achieved at least a 90% improvement in Psoriasis Scalp Severity Index response and a notable change from baseline in scalp-specific itch with Sotyktu treatment compared to placebo.
Psoriasis affects at least 100 million people worldwide, causing inflammation in the body. Scalp psoriasis occurs in approximately 80% of patients with plaque psoriasis, the most common form of the condition, and is associated with itching, flaking, pain, and bleeding.
Sotyktu is already approved in major markets for treating certain patients with moderate-to-severe plaque psoriasis, having shown in late-stage trials to improve skin clearance, symptom burden, and quality of life.
Additionally, BMS presented positive data from its Registry of Psoriasis Health Outcomes: A Longitudinal Real-World Collaboration Study (RePhlect) involving 118 patients, 108 of whom had moderate-to-severe plaque psoriasis. The analysis found that the effectiveness of continuous Sotyktu treatment after six months in real-world registry patients was consistent with efficacy outcomes observed in the POETYK PSO clinical studies.
Daniel Quirk, senior vice president, worldwide immunology and neuroscience medical affairs at BMS, commented on the results: “This data further demonstrates the safety and efficacy of Sotyktu for the treatment of psoriasis in high-impact areas, such as the scalp… We believe Sotyktu has the potential to be the systemic therapy that healthcare providers turn to when treating adult patients with moderate-to-severe psoriasis, especially those with scalp involvement.”