Bristol Myers Squibb Unveils Sotyktu Efficacy Data in Scalp Psoriasis and Real-World Use

Bristol Myers Squibb has announced promising results from the Phase 3b/4 PSORIATYK SCALP trial, which evaluated the efficacy and safety of Sotyktu (deucravacitinib) for treating moderate-to-severe scalp psoriasis. This condition impacts around 80% of individuals with plaque psoriasis and significantly affects their quality of life due to symptoms like itching, flaking, pain, and bleeding.

The trial's primary endpoint was the scalp-specific Physician's Global Assessment (ss-PGA) response, aiming for a score of 0 or 1 (clear or almost clear) at 16 weeks. Sotyktu showed a substantial improvement, with 48.5% of patients reaching ss-PGA 0/1 compared to 13.7% on placebo. Additionally, the treatment met key secondary endpoints, including a 90% improvement in the Psoriasis Scalp Severity Index (PSSI) and significant reductions in scalp-specific itch, pain, and flaking.

The trial's results, presented at the European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, highlight Sotyktu's efficiency. Dr. Mark Lebwohl from the Icahn School of Medicine at Mount Sinai emphasized the positive impact of Sotyktu on scalp psoriasis, reinforcing its potential as a safe and effective once-daily oral treatment for moderate-to-severe psoriasis.

Alongside the clinical trial, an interim analysis of the RePhlect registry, which tracks real-world patient outcomes, supported the efficacy of Sotyktu. This study observed similar results to the POETYK clinical trials, demonstrating significant improvements in disease severity measures, including Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), and Investigator’s Global Assessment (IGA) scores.

Dr. Daniel Quirk, senior vice president at Bristol Myers Squibb, highlighted the consistent effectiveness of Sotyktu in real-world settings, particularly for treating high-impact areas such as the scalp. The findings suggest that Sotyktu could become a standard systemic therapy for moderate-to-severe psoriasis, especially for patients with scalp involvement.

The PSORIATYK SCALP trial is a 52-week, Phase 3b/4 multicenter study, involving 154 patients. It assessed the efficacy and safety of Sotyktu in patients with moderate-to-severe scalp psoriasis, defined by specific baseline measures like ss-PGA, PSSI, and Scalp Surface Area (SSA). The trial's positive outcomes further solidify Sotyktu's safety profile, aligning with previous studies on psoriasis.

Real-world data from the RePhlect registry, a prospective observational study, also reinforced Sotyktu's effectiveness. The registry includes 118 patients, primarily those with moderate-to-severe plaque psoriasis. The data showed significant reductions in disease severity, consistent with clinical trial outcomes, further validating Sotyktu’s potential in real-world applications.

Psoriasis is a chronic, systemic immune-mediated disease affecting over 100 million people globally. It significantly impairs patients' physical health, quality of life, and work productivity. Psoriasis is associated with various comorbidities, including psoriatic arthritis, cardiovascular disease, and depression. Scalp psoriasis, affecting about 80% of plaque psoriasis patients, exacerbates these impacts due to its challenging symptoms and treatment difficulties.

Sotyktu (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor. It represents a new class of small molecules designed to target TYK2 selectively, inhibiting the signaling of key cytokines involved in immune-mediated diseases. This targeted approach helps manage diseases like psoriasis without significantly affecting other kinases like JAK1, JAK2, or JAK3.

Bristol Myers Squibb continues to explore Sotyktu's potential across multiple immune-mediated diseases, aiming to provide effective treatment options and improve patient care. The company appreciates the contributions of patients and investigators involved in ongoing trials and studies, such as PSORIATYK SCALP and RePhlect.