JAAD international · 2025
Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate to severe scalp psoriasis: Efficacy and safety results through week 16 in a phase 3b/4, multicenter, randomized, double-blinded, placebo-controlled trial (PSORIATYK SCALP).
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Duffin Kristina Callis, Griffiths Christopher E M, Hoffmann Matthias, Blauvelt Andrew, Balagula Yevgeniy, Napoli Andrew, Becker Brandon, Jou Ying-Ming, Dyme Rachel, Hala Virginia, Pinter Andreas, Thaçi Diamant, Gold Linda Stein, Lebwohl Mark
Аннотация
BACKGROUND: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in multiple countries for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
OBJECTIVE: The 52-week, phase 3b/4 PSORIATYK SCALP (NCT05478499) trial evaluated deucravacitinib efficacy and safety in scalp psoriasis, including patients with more limited overall psoriasis. Here, we report week 16 results.
METHODS: Adults with moderate to severe scalp psoriasis and body surface area involvement ≥ 3% were randomized 1:2 to placebo (n = 51) or deucravacitinib 6 mg once daily (n = 103) through week 16. The primary efficacy endpoint was scalp-specific Physician Global Assessment score of 0/1; key secondary endpoints were Psoriasis Scalp Severity Index 90, scalp-specific numeric rating scale itch score, and static Physician Global Assessment (sPGA) 0/1.
RESULTS: In the overall population, scalp-specific Physician Global Assessment score of 0/1 (48.5% vs 13.7%; P < .0001), Psoriasis Scalp Severity Index 90 (38.8% vs 2.0%; P < .0001), and mean change from baseline in scalp-specific numeric rating scale itch (-3.2 vs -0.7; P < .0001) were superior with deucravacitinib versus placebo. In the sPGA ≥ 3 subpopulation, sPGA 0/1 was superior with deucravacitinib (51.0% vs 4.3%; P < .0001). Adverse events were comparable between groups.
LIMITATIONS: 16-week analysis.
CONCLUSION: Deucravacitinib was efficacious and well tolerated in patients with moderate to severe scalp psoriasis.
OBJECTIVE: The 52-week, phase 3b/4 PSORIATYK SCALP (NCT05478499) trial evaluated deucravacitinib efficacy and safety in scalp psoriasis, including patients with more limited overall psoriasis. Here, we report week 16 results.
METHODS: Adults with moderate to severe scalp psoriasis and body surface area involvement ≥ 3% were randomized 1:2 to placebo (n = 51) or deucravacitinib 6 mg once daily (n = 103) through week 16. The primary efficacy endpoint was scalp-specific Physician Global Assessment score of 0/1; key secondary endpoints were Psoriasis Scalp Severity Index 90, scalp-specific numeric rating scale itch score, and static Physician Global Assessment (sPGA) 0/1.
RESULTS: In the overall population, scalp-specific Physician Global Assessment score of 0/1 (48.5% vs 13.7%; P < .0001), Psoriasis Scalp Severity Index 90 (38.8% vs 2.0%; P < .0001), and mean change from baseline in scalp-specific numeric rating scale itch (-3.2 vs -0.7; P < .0001) were superior with deucravacitinib versus placebo. In the sPGA ≥ 3 subpopulation, sPGA 0/1 was superior with deucravacitinib (51.0% vs 4.3%; P < .0001). Adverse events were comparable between groups.
LIMITATIONS: 16-week analysis.
CONCLUSION: Deucravacitinib was efficacious and well tolerated in patients with moderate to severe scalp psoriasis.