Phase 3, real-world data show deucravacitinib efficacious for scalp, overall psoriasis
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Key takeaways:
- Deucravacitinib maintained efficacy and safety when treating psoriasis up to 6 months.
- Findings were drawn from the phase 3 trial, PSORIATYK SCALP, and the real-world study, RePhlect.
Deucravacitinib proved to be efficacious in the treatment of moderate to severe scalp psoriasis and less extensive overall psoriasis, according to two presentations at the European Academy of Dermatology and Venerology Congress.
The first study, PSORIATYK SCALP, is a 52-week ongoing trial evaluating the effectiveness of oral deucravacitinib (Sotyktu, Bristol Myers Squibb) for the treatment of psoriasis on the scalp.
“Approximately 80% of individuals with moderate to severe plaque psoriasis are affected in their scalp, which is an area that can be difficult to treat,” Dan Quirk, MD, MPH, MBA, senior vice president of worldwide immunology and neuroscience medical affairs at Bristol Myers Squibb, told Healio. “The PSORIATYK SCALP results demonstrate that Sotyktu is a safe and effective treatment for these people, especially those who prefer the convenience of a once-daily oral medication.”
In the study, 154 patients with scalp psoriasis were randomly assigned deucravacitinib (n = 103) or placebo (n = 51). Results showed that 48.5% of deucravacitinib-treated patients achieved a scalp-specific PGA score of 0 or 1 vs. 13.7% of the placebo group at week 16 (P < .0001).
In the same time period, 38.8% of treated patients reported a 90% improvement in their scalp psoriasis severity compared with only 2% of the placebo group (P < .0001). Deucravacitinib-treated patients also reported higher changes in itch from baseline compared with the placebo group (–3.2 vs. –0.7; P < .0001).
Those in the deucravacitinib vs. placebo group achieved higher rates of relief in key psoriasis symptoms including scalp-specific itch (41.7% vs. 9.8%; P < .0001), pain (26.2% vs. 11.8%; P = .0372) and flaking (53.4% vs. 19.6%; P < .0001).
Deucravacitinib maintained a similar safety profile to previous trials in this indication.
The second study was an interim analysis of the real-world RePhlect registry evaluating 118 patients, 108 of whom had moderate to severe plaque psoriasis. The analysis found that the effectiveness over the span of 6 months of continuous deucravacitinib treatment in real-world registry patients was consistent with efficacy outcomes observed in the POETYK PSO clinical studies.
Results showed that 67.9% and 64.1% of patients treated with deucravacitinib achieved PASI scores of 3 or less and body surface area involvement scores of 3% or less. IGA scores of 0 or 1 were also reached by 46.8% of those in the all-severity patients.
“These findings from the RePhlect study provide confidence that dermatologists can experience similar efficacy results for their patients in real-world practice,” Quirk told Healio.
Editor's note: The third to last paragraph was reworded for clarification.
References:
- Armstrong AW, et al. Real-world effectiveness of deucravacitinib in patients with plaque psoriasis: 6-month interim analysis of skin clearance from the RePhlect Registry. Poster: European Academy of Dermatology and Venereology Congress; Sept. 25-28, 2024; Amsterdam.
- Lebwohl M, et al. Deucravacitinib, an oral selective tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate to severe scalp psoriasis: efficacy and safety results of a phase 3b/4, multicenter, randomized, double-blinded, placebo-controlled trial (PSORIATYK SCALP). Presented at: European Academy of Dermatology and Venereology Congress; Sept. 25-28, 2024; Amsterdam.