Deucravacitinib Effective Across All Endpoints at Week 16 for Scalp Psoriasis

Mark Lebwohl, MD

Credit: Arcutis Biotherapeutics

New data announced by Bristol Myers Squibb highlight positive results from the phase 3b/4 PSORIATYK SCALP study on orally-administered deucravacitinib (Sotyktu) for the treatment of individuals with moderate-to-severe scalp psoriasis, as well as those reporting less extensive overall psoriasis.1

These data from PSORIATYK SCALP data were presented at the European Academy of Dermatology and Venereology (EADV) Congress. The trial’s findings on the efficacy and safety of the drug for patients highlight the medication’s potential in the psoriasis therapy armamentarium.

“Approximately 80% of people living with plaque psoriasis have scalp involvement and typically experience itching, flaking, pain and bleeding, which greatly diminish their quality of life,” Mark Lebwohl, MD, Icahn School of Medicine at Mount Sinai’s dean of clinical therapeutics and investigator and paid consultant for Bristol Myers Squibb, said in a statement. “These new results reinforce that oral (deucravacitinib) is a safe and effective once-daily treatment for people living with moderate-to-severe psoriasis, with involvement of high impact areas such as the scalp.”

Psoriasis is a skin disease which is chronic and immune-mediated, impacting one’s entire body, quality of life, and productivity at work. There are said to be more than 100 million people worldwide living with some form of psoriasis, with 14 million in Europe and 7.5 million in the US specifically. Around 25% of these individuals have cases classified as moderate to severe.

Deucravacitinib is an orally-administered drug designed to selectively inhibit tyrosine kinase 2 (TYK2). It is the first of its kind and functions by targeting TYK2 to block key cytokine signaling, including interleukin (IL)-23, IL-12, and Type 1 interferons (IFN). The drug was approved by the US Food and Drug Administration (FDA) in 2022 for adults patients with moderate to severe psoriasis who are eligible for systemic or phototherapy.²

The PSORIATYK SCALP trial, covered at EADV, was a 52-week, phase 3b/4 analysis assessing the drug’s safety and effectiveness among those with a Psoriasis Scalp Severity Index (PSSI) score of 12 or more, a scalp-specific Physician’s Global Assessment (ss-PGA) score of 3 or more, and involvement on their scalp surface of at least 20%, in addition to reported body surface area involvement of 3% minimum.¹

There were a total of 154 subjects included in this study, with 103 in the treatment arm and 51 in the placebo arm. The investigators’ main endpoint assessed was the percentage of individuals participating who achieved a ss-PGA score of 0 or 1, suggesting skin being clear or almost clear.

In terms of their key secondary endpoints, the team looked for 90% improvement in PSSI, reduction in scalp-specific itch, as well as achievement of an sPGA score of 0 or 1.

After their assessment, the investigators concluded that their primary endpoint had been met, with 48.5% of subjects in the deucravacitinib treatment cohort achieving ss-PGA 0/1 versus only 13.7% in the placebo cohort (P < .0001). Significant PSSI response improvements were also noted by the team, with 38.8% of those in the treatment arm versus 2.0% for placebo.

The investigators also reported better outcomes among those given the drug for pain, pruritus, and flaking compared to the placebo arm. They also noted that sPGA scores in subjects with severe disease treated with the drug were superior.

Substantial reductions in whole-body itch scores were additionally reported by the research team. In terms of its safety profile, deucravacitinib was shown to have consistent safety data with that of prior psoriasis research. Common side effects included upper respiratory tract infections, nasopharyngitis, headache, acne, and COVID-19 infections.

References

1. ^{Bristol Myers Squibb Presents New Data from Two Trials Demonstrating Sotyktu (deucravacitinib) Efficacy in both Moderate-to-Severe Scalp Psoriasis and in a Real-Worldn Setting. Bristol Myers Squibb. September 27, 2024. https://news.bms.com/news/details/2024/Bristol-Myers-Squibb-Presents-New-Data-from-Two-Trials-Demonstrating-Sotyktu-deucravacitinib-Efficacy-in-both-Moderate-to-Severe-Scalp-Psoriasis-and-in-a-Real-World-Setting/default.aspx. Date accessed: October 2, 2024.}
2. ^{Smith T. FDA Approves Deucravacitinib for Adults with Plaque Psoriasis. HCPLive. September 12, 2022. https://www.hcplive.com/view/fda-approves-deucravacitinib-adults-plaque-psoriasis. Date accessed: October 2, 2024.}