Long‐term efficacy, safety and tolerability of secukinumab in children and adolescents with severe chronic plaque psoriasis: Two‐year results from a Phase III double‐blind, randomized controlled trial

塞库金单抗 医学 安慰剂 银屑病面积及严重程度指数 耐受性 皮肤科生活质量指数 银屑病 随机对照试验 临床试验 不利影响 皮肤病科 内科学 银屑病性关节炎 病理 替代医学
作者
Dorota Krasowska,Thilo Gambichler,Camilo A. Cortés,Amir Horev,N. Compagno,Swapnil Dahale,P. Papanastasiou,Deborah Keefe
出处
期刊:Journal of The European Academy of Dermatology and Venereology [Wiley]
卷期号:37 (8): 1616-1625 被引量:3
标识
DOI:10.1111/jdv.19063
摘要

Secukinumab has previously demonstrated sustained efficacy and favourable safety for up to 52 weeks in paediatric patients (children and adolescents aged 6 to <18 years) with severe chronic plaque psoriasis (NCT02471144).To investigate the long-term (104 weeks) efficacy and safety of secukinumab.After 52 weeks, patients continued to receive secukinumab low dose (LD [75/150 mg]) or high dose (HD [75/150/300 mg]). Patients on etanercept (0.8 mg/kg) until Week 52 entered follow-up. Data for patients receiving secukinumab LD from the beginning and those switching to secukinumab LD from placebo ('Any secukinumab' LD) and patients receiving secukinumab HD from the beginning and those switching to secukinumab HD from placebo ('Any secukinumab' HD) are presented.Psoriasis Area and Severity Index (PASI) score, PASI (75/90/100) responses, Investigator's Global Assessment modified 2011 (IGA mod 2011) 0/1 response, Children's Dermatology Life Quality Index (CDLQI) score and CDLQI 0/1 response up to Week 104, and, safety up to Week 104 for all patients and up to 4 years for some patients (~320 patient-years [PY] of treatment).Secukinumab-treated patients showed sustained PASI 75/90/100 and IGA mod 2011 0/1 responses up to Week 104. Throughout the second year of treatment, efficacy was similar for the 'Any secukinumab' LD and HD groups for PASI 75 and IGA mod 2011 0/1 responses. PASI 90/100 responses were mostly comparable between the dose groups up to Week 88, but higher in the 'Any secukinumab' HD than the 'Any secukinumab' LD group at Week 104. Patients achieved a sustained CDLQI 0/1 response that was similar between the 'Any secukinumab' LD (61.1%) and HD (65.0%) groups. Safety data were consistent with the established safety profile of secukinumab.Secukinumab demonstrated sustained long-term efficacy (up to 2 years) and a favourable safety profile (~320 PY of treatment) in paediatric patients with severe chronic plaque psoriasis.
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