Bristol Myers Squibb (NYSE:BMY) has announced promising results from the Phase 3b/4 PSORIATYK SCALP trial, which assessed the efficacy of Sotyktu (deucravacitinib) in treating patients with moderate-to-severe scalp psoriasis, including those with less extensive psoriasis. The trial met its primary endpoint, showing a statistically significant improvement in the scalp-specific Physician’s Global Assessment (ss-PGA) response of 0 or 1 (clear/almost clear) at 16 weeks. Notably, over three times as many patients achieved ss-PGA 0/1 with Sotyktu treatment compared to those receiving placebo (48.5% vs. 13.7%, p<0.0001).
Bristol Myers Squibb has announced new efficacy and safety results from the PSORIATYK SCALP trial, which evaluates Sotyktu (deucravacitinib) for moderate-to-severe scalp psoriasis. These findings, along with patient-reported outcomes and 23 additional abstracts, are being presented at the European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam from September 25-28, 2024.
Dr. Mark Lebwohl, dean of Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai, noted that about 80% of individuals with plaque psoriasis experience scalp involvement, which can significantly impact their quality of life. He emphasized that the new results demonstrate Sotyktu’s effectiveness and safety as a once-daily treatment for moderate-to-severe psoriasis, particularly in high-impact areas like the scalp.
The trial met key secondary endpoints at Week 16, showing a significantly higher percentage of patients achieving at least a 90% improvement in the Psoriasis Scalp Severity Index (PSSI) and a notable reduction in scalp-specific itch compared to placebo (PSSI 90: 38.8% vs. 2.0%, p<0.0001; mean change in itch -3.2 vs. -0.7, p<0.0001). Additionally, among patients with a Static Physician’s Global Assessment (sPGA) score of ≥3, 51.0% achieved sPGA 0/1 with Sotyktu, compared to just 4.3% with placebo (p<0.0001).
Patients treated with Sotyktu also reported greater improvements in achieving the minimum clinically important difference (MCID) for scalp-specific itch (41.7% vs. 9.8%; p<0.0001), pain (26.2% vs. 11.8%; p=0.0372), and flaking (53.4% vs. 19.6%; p<0.0001). The safety profile of Sotyktu was consistent with previous trials, with the most common adverse events being nasopharyngitis (14.6%), upper respiratory infections (11.7%), and acne (9.7%).
In addition, a real-world interim analysis from the Registry of Psoriasis Health Outcomes (RePhlect) showed that Sotyktu maintains consistent effectiveness after six months of treatment. Among 118 patients analyzed, statistically significant mean decreases were observed in measures of disease severity, including the Psoriasis Area and Severity Index (PASI) and Body Surface Area (BSA).
Dr. Daniel Quirk, senior vice president of worldwide Immunology and Neuroscience medical affairs at Bristol Myers Squibb, remarked that these data highlight Sotyktu’s potential as a systemic therapy for moderate-to-severe psoriasis, particularly in patients with scalp involvement.
Sotyktu is also being studied for various immune-mediated diseases, and Bristol Myers Squibb expresses gratitude to the patients and investigators involved in the PSORIATYK SCALP trial and the RePhlect study.
About the PSORIATYK SCALP Trial
The PSORIATYK SCALP trial (NCT05478499) is an ongoing 52-week Phase 3b/4 multicenter, randomized, double-blind, placebo-controlled trial evaluating Sotyktu in patients with moderate-to-severe scalp psoriasis. The trial included 154 patients, with the primary endpoint being the percentage of patients achieving a ss-PGA score of 0 or 1 at Week 16.
About RePhlect
RePhlect (NCT05744466) is a prospective, observational study targeting 2,500 patients with dermatologist-diagnosed psoriasis across six countries, with enrollment beginning in September 2023. Data from the North American cohort are collected through the CorEvitas Psoriasis Registry, developed in collaboration with the National Psoriasis Foundation.
