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.

Data from the ongoing PSORIATYK SCALP trial, which included patients with less extensive overall psoriasis, were presented at this year’s European Academy of Dermatology and Venereology Congress.

The primary endpoint was met, with more than three times as many patients achieving 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.

Key secondary endpoints were also met at week 16, with a significantly higher percentage of patients achieving at least a 90% improvement in Psoriasis Scalp Severity Index response and a change from baseline in scalp-specific itch with Sotyktu treatment compared with placebo.

At least 100 million people worldwide are affected by psoriasis, an immune-mediated disease that causes 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 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.

Alongside data from PSORIATYK SCALP, BMS also presented positive data from its Registry of Psoriasis Health Outcomes: A Longitudinal Real-World Collaboration Study (RePhlect) of 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 in patients with moderate-to-severe plaque psoriasis.