Real-world Drug Survival of Biosimilar SB5 vs GP2017 Following a Mandatory Non-medical Switch from Adalimumab Originator for Psoriasis: A Nationwide Cohort Study.

IF 3.5 4区 医学 Q1 DERMATOLOGY
Johan Sieborg, Julia-Tatjana Maul, Jashin J Wu, Nikolai Nguyen Loft, Lone Skov, Lars Erik Bryld, Mads Kirchheiner Rasmussen, Tomas Norman Dam, Trine Bertelsen, Kawa Khaled Ajgeiy, Simon Francis Thomsen, Jacob P Thyssen, Alexander Egeberg, David Thein
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Abstract

Biosimilars are designed to be analogous to the biologic originators. However, comprehensive comparisons between biosimilars are limited and lacking for patients with psoriasis. This study's objective was to compare 1-year drug survival of the 2 adalimumab biosimilars, GP2017 with SB5, following a non-medical mandatory switch from the adalimumab originator. Based on the national clinical database DERMBIO, this nationwide cohort study included all patients with psoriasis treated with the adalimumab originator who underwent a non-medical mandatory switch to GP2017 or SB5. The study included 525 patients switching from adalimumab originator to 1 of 2 biosimilars: GP2017 (n=267 patients) or SB5 (n=258 patients). When comparing the drug survival of the biosimilars, the hazard ratio was 1.11 (95% confidence interval, 0.58-2.12) for SB5 with GP2017 as reference. In the sensitivity analysis investigating changes in PASI, no differences were found when comparing the GP2017 group and the SB5 group at 120 days of follow-up (1.9% vs 1.6% improved, 1.9% vs 2.0% worsened, and 43.1% vs 40.9% remained unchanged). When comparing GP2017 and SB5, no discernible differences were found in drug survival or effectiveness based on PASI. Determining drug survival and effectiveness could benefit patients and clinicians in treatment decisions.

生物仿制药的设计类似于生物原研药。然而,对于银屑病患者来说,生物仿制药之间的全面比较是有限的,也是缺乏的。本研究的目的是比较两种阿达木单抗生物仿制药GP2017和SB5在从阿达木单抗原研药进行非医疗强制转换后的1年药物存活率。这项全国性队列研究以国家临床数据库DERMBIO为基础,纳入了所有接受阿达木单抗原研药治疗并接受非医疗强制换药至GP2017或SB5的银屑病患者。该研究包括525名从阿达木单抗原研药转为两种生物仿制药中的一种的患者:GP2017(267 名患者)或 SB5(258 名患者)。在比较两种生物仿制药的药物存活率时,SB5 的危险比为 1.11(95% 置信区间,0.58-2.12),GP2017 为参考值。在调查 PASI 变化的敏感性分析中,GP2017 组和 SB5 组在随访 120 天时没有发现差异(1.9% 对 1.6%,1.9% 对 2.0%,43.1% 对 40.9%)。在比较 GP2017 和 SB5 时,没有发现基于 PASI 的药物存活率或有效性有明显差异。确定药物的存活率和有效性有利于患者和临床医生做出治疗决定。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Acta dermato-venereologica
Acta dermato-venereologica 医学-皮肤病学
CiteScore
4.90
自引率
2.80%
发文量
210
审稿时长
6-12 weeks
期刊介绍: Acta Dermato-Venereologica publishes high-quality manuscripts in English in the field of Dermatology and Venereology, dealing with new observations on basic dermatological and venereological research, as well as clinical investigations. Each volume also features a number of Review articles in special areas, as well as short Letters to the Editor to stimulate debate and to disseminate important clinical observations. Acta Dermato-Venereologica has rapid publication times and is amply illustrated with a large number of colour photographs.
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