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司库奇尤单抗治疗新发银屑病:旨在了解疾病改善的潜力——随机、多中心 STEPIn 研究的原理和设计。

Secukinumab treatment in new-onset psoriasis: aiming to understand the potential for disease modification - rationale and design of the randomized, multicenter STEPIn study.

机构信息

Aarhus University Hospital, Aarhus, Denmark.

Department of Dermatology, Karolinska University Hospital, Stockholm, Sweden.

出版信息

J Eur Acad Dermatol Venereol. 2018 Nov;32(11):1930-1939. doi: 10.1111/jdv.14979. Epub 2018 Jul 15.

DOI:10.1111/jdv.14979
PMID:29633373
Abstract

BACKGROUND

To date, biological treatments have been assessed in subjects with a long-term history of psoriasis and previous failures to systemic and topical therapies. In rheumatoid arthritis and other immune-mediated inflammatory diseases, early intensive systemic treatment prolongs treatment-free remission. We hypothesize that, by treating patients with psoriasis early with an effective systemic therapy, we may be able to alter the clinical outcome and the natural course of the disease. The STEPIn study (NCT03020199) investigates early intervention with secukinumab versus narrow-band ultraviolet B (nb-UVB) phototherapy in subjects with new-onset psoriasis.

OBJECTIVE

To determine whether early intervention with either nb-UVB treatment or secukinumab in subjects with new-onset plaque psoriasis might modify the natural course of the disease.

METHODS

One hundred and sixty subjects aged 18-50 years with new-onset (≤12 months) moderate-to-severe plaque psoriasis and naïve to systemic treatment and phototherapy will be randomized to secukinumab 300 mg or nb-UVB. The Main Study has two treatment arms: Arm A1, subcutaneous secukinumab 300 mg at baseline, Weeks 1, 2, 3 and 4, and every 4 weeks thereafter until and including Week 52; Arm B1, one/two cycles of nb-UVB for 12 weeks each (maximum 28-week break between cycles). After treatment discontinuation, patients will be followed up and monitored for disease activity up to Week 208. A Mechanistic Sub-study will assess immunological changes and pathogenic tissue-resident memory T cells in skin biopsies.

CONCLUSIONS

STEPIn is the first study to investigate whether early intensive treatment in new-onset psoriasis can modify the long-term natural course of the disease and thus become a novel treatment strategy for patients with psoriasis.

摘要

背景

迄今为止,生物制剂已在有长期银屑病病史和既往系统性及局部治疗失败的患者中进行了评估。在类风湿关节炎和其他免疫介导的炎症性疾病中,早期强化系统性治疗可延长无治疗缓解期。我们假设,通过早期对银屑病患者进行有效的系统性治疗,我们可能能够改变其临床结局和疾病自然病程。STEPIn 研究(NCT03020199)调查了早期使用司库奇尤单抗与窄谱中波紫外线(nb-UVB)光疗治疗新发银屑病患者的效果。

目的

确定早期使用 nb-UVB 治疗或司库奇尤单抗治疗新发斑块型银屑病患者是否可以改变疾病的自然病程。

方法

160 名年龄在 18-50 岁之间、新发(≤12 个月)、中重度斑块型银屑病且既往未接受过系统治疗和光疗的患者将被随机分配至司库奇尤单抗 300mg 或 nb-UVB 组。主要研究有两个治疗组:A1 组,基线时给予司库奇尤单抗 300mg 皮下注射,第 1、2、3 和 4 周,此后每 4 周 1 次,直至第 52 周;B1 组,nb-UVB 治疗 12 周,每 12 周为 1 个疗程(两个疗程之间最大间隔 28 周)。停止治疗后,将对患者进行随访并监测疾病活动度至第 208 周。一项机制子研究将评估皮肤活检中的免疫学变化和致病性组织驻留记忆 T 细胞。

结论

STEPIn 是第一项研究早期强化治疗新发银屑病是否能改变疾病的长期自然病程的研究,因此可能成为银屑病患者的一种新的治疗策略。

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