Effect of spesolimab on sustained disease control in patients with generalized pustular psoriasis: Post hoc analysis of the EFFISAYIL 2 study

IF 11.8 1区医学 Q1 DERMATOLOGY Journal of the American Academy of Dermatology Pub Date : 2025-06-01 Epub Date: 2025-03-07 DOI:10.1016/j.jaad.2025.01.089

Kenneth B. Gordon MD , Matthias Augustin MD, PhD , Jonathan Barker MD, MRCP , Yayoi Tada MD, PhD , Mark G. Lebwohl MD , Ming Tang PhD , Patrick Hofmann PhD , Christian Thoma MD , Alice B. Gottlieb MD, PhD

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Abstract

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.

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spesolimab对广泛性脓疱性银屑病患者持续疾病控制的影响：EFFISAYIL 2研究的事后分析

背景：全身性脓疱性银屑病（GPP）是一种病程难以预测的慢性炎症性疾病。长期治疗目标包括持续解决皮肤症状，预防新的耀斑，改善生活质量（QoL）。目的：比较白细胞介素-36受体单克隆抗体spesolimab 600 mg皮下（SC）负荷剂量（LD）随后每4周（q4w） 300 mg皮下（SC）与安慰剂对GPP患者皮肤症状和生活质量负担的影响。方法：对EFFISAYIL 2试验（NCT04399837）进行事后分析，评估持续改善皮肤症状的患者比例（GPP医师总体评估总分，0或1）和生活质量负担（皮肤病生活质量指数评分，0或1），直到第48周。结果：在接受spesolimab 600 mg SC LD和300 mg SC q4w的患者中，63.3%的患者皮肤症状持续改善(vs 29.0%；安慰剂)，24.1%的患者生活质量负担持续改善(vs 3.2%；安慰剂)。局限性：回顾性、描述性、事后分析。结论：与安慰剂相比，Spesolimab 600 mg SC LD和300 mg SC q4w可显著提高GPP患者皮肤症状和生活质量负担的持续改善。

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来源期刊

Journal of the American Academy of Dermatology 医学-皮肤病学

CiteScore

8.60

自引率

5.80%

发文量

2023

审稿时长

49 days

期刊介绍： The Journal of the American Academy of Dermatology (JAAD) is the official scientific publication of the American Academy of Dermatology (AAD). Its primary goal is to cater to the educational requirements of the dermatology community. Being the top journal in the field, JAAD publishes original articles that have undergone peer review. These articles primarily focus on clinical, investigative, and population-based studies related to dermatology. Another key area of emphasis is research on healthcare delivery and quality of care. JAAD also highlights high-quality, cost-effective, and innovative treatments within the field. In addition to this, the journal covers new diagnostic techniques and various other topics relevant to the prevention, diagnosis, and treatment of skin, hair, and nail disorders.