Bristol Myers Squibb reports positive Sotyktu data for moderate-to-severe psoriasis

Bristol Myers Squibb (BMS) has reported promising outcomes from a phase 3b/4 study evaluating its oral TYK2 inhibitor, Sotyktu (deucravacitinib), for moderate-to-severe scalp psoriasis. The results were shared at the European Academy of Dermatology and Venereology Congress.

The PSORIATYK SCALP trial, which involved patients with less extensive overall psoriasis, aimed to determine the efficacy of Sotyktu in treating scalp-specific symptoms. The primary endpoint of the study was successfully achieved. At week 16, 48.5% of patients receiving Sotyktu reached a scalp-specific Physician’s Global Assessment (PGA) score of zero or one (clear/almost clear), compared to 13.7% of those on a placebo.

In addition to the primary endpoint, key secondary endpoints were also met at week 16. A significantly higher percentage of patients treated with Sotyktu experienced at least a 90% improvement in the Psoriasis Scalp Severity Index (PSSI). Patients also reported a notable reduction in scalp-specific itch compared to the placebo group.

Psoriasis, an immune-mediated disease affecting over 100 million people worldwide, leads to inflammation throughout the body. Scalp psoriasis is common among approximately 80% of plaque psoriasis patients, resulting in symptoms like itching, flaking, pain, and bleeding.

Sotyktu has already received approval in major markets for treating certain patients with moderate-to-severe plaque psoriasis. It has demonstrated effectiveness in late-stage trials by improving skin clearance, reducing symptom burden, and enhancing the quality of life for patients.

In addition to the PSORIATYK SCALP trial data, BMS also presented encouraging findings from the Registry of Psoriasis Health Outcomes: A Longitudinal Real-World Collaboration Study (RePhlect). This study included 118 patients, 108 of whom had moderate-to-severe plaque psoriasis. The analysis indicated that the continuous use of Sotyktu over six months in real-world settings yielded efficacy outcomes consistent with those observed in the POETYK PSO clinical trials.

Daniel Quirk, senior vice president of worldwide immunology and neuroscience medical affairs at BMS, commented on the latest findings: “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.”

These new results support the potential of Sotyktu as a robust treatment option for patients struggling with moderate-to-severe scalp psoriasis, particularly those whose condition significantly impacts their daily lives.