Journal of the American Academy of Dermatology · 2025
Effect of spesolimab on sustained disease control in patients with generalized pustular psoriasis: Post hoc analysis of the EFFISAYIL 2 study.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Gordon Kenneth B, Augustin Matthias, Barker Jonathan, Tada Yayoi, Lebwohl Mark G, Tang Ming, Hofmann Patrick, Thoma Christian, Gottlieb Alice B
Аннотация
BACKGROUND: Generalized pustular psoriasis (GPP) is a chronic inflammatory disease with an unpredictable disease course. Long-term treatment goals include sustained resolution of skin symptoms, prevention of new flares, and improvement in quality of life (QoL).
OBJECTIVE: To compare the effect of the interleukin-36 receptor monoclonal antibody spesolimab 600 mg subcutaneous (SC) loading dose (LD) followed by 300 mg SC every 4 weeks (q4w) versus placebo on skin symptoms and QoL burden in patients with GPP.
METHODS: A post hoc analysis of the EFFISAYIL 2 trial (NCT04399837) was conducted to assess the proportion of patients with sustained improvement of skin symptoms (GPP Physician Global Assessment total score, 0 or 1) and QoL burden (Dermatology Life Quality Index score, 0 or 1) at all visits up to week 48.
RESULTS: Among the patients who received spesolimab 600 mg SC LD followed by 300 mg SC q4w, 63.3% had sustained improvement of skin symptoms (vs 29.0%; placebo), and 24.1% had sustained improvement of QoL burden (vs 3.2%; placebo).
LIMITATIONS: Retrospective, descriptive, post hoc analysis.
CONCLUSION: Spesolimab 600 mg SC LD followed by 300 mg SC q4w provides sustained improvement of skin symptoms and QoL burden in a substantially higher proportion of patients with GPP versus placebo.
OBJECTIVE: To compare the effect of the interleukin-36 receptor monoclonal antibody spesolimab 600 mg subcutaneous (SC) loading dose (LD) followed by 300 mg SC every 4 weeks (q4w) versus placebo on skin symptoms and QoL burden in patients with GPP.
METHODS: A post hoc analysis of the EFFISAYIL 2 trial (NCT04399837) was conducted to assess the proportion of patients with sustained improvement of skin symptoms (GPP Physician Global Assessment total score, 0 or 1) and QoL burden (Dermatology Life Quality Index score, 0 or 1) at all visits up to week 48.
RESULTS: Among the patients who received spesolimab 600 mg SC LD followed by 300 mg SC q4w, 63.3% had sustained improvement of skin symptoms (vs 29.0%; placebo), and 24.1% had sustained improvement of QoL burden (vs 3.2%; placebo).
LIMITATIONS: Retrospective, descriptive, post hoc analysis.
CONCLUSION: Spesolimab 600 mg SC LD followed by 300 mg SC q4w provides sustained improvement of skin symptoms and QoL burden in a substantially higher proportion of patients with GPP versus placebo.