依那西普和英夫利昔单抗启动者的严重感染发生率:生物仿制药和生物原研药与加拿大人群数据的安全性比较。

IF 2.1 Q3 RHEUMATOLOGY BMC Rheumatology Pub Date : 2024-09-27 DOI:10.1186/s41927-024-00415-5
Marina G Birck, Luck Lukusa, Denis Choquette, Gilles Boire, Walter P Maksymowych, Harminder Singh, Waqqas Afif, Sasha Bernatsky
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引用次数: 0

摘要

背景:安全性仍然是生物制药的一个重大问题,需要进行研究以确保生物仿制药及其传统疗法具有可比的安全性。我们利用 2015-2019 年的加拿大行政健康数据,比较了生物仿制药和生物原研药启动者在依那西普(etanercept)和英夫利昔单抗(infliximab)严重感染的发生率,依那西普和英夫利昔单抗是这一时期最常用的两种生物制剂:我们使用国家处方药使用信息系统(National Prescription Drug Utilization Information System)中与住院数据相关联的泛加拿大(魁北克除外)数据进行了一项回顾性队列研究。我们研究了英夫利昔单抗或依那西普(etanercept)的新用户(2015 年 1 月至 2019 年 12 月),并比较了严重感染(定义为需要住院治疗的感染)的发生率,采用 Cox 回归模型,根据生物性别、开始治疗时的年龄、之前使用的皮质类固醇或生物制剂、省份和日历年进行调整:我们对 6583 名依那西普使用者(平均年龄 62 岁)和 7202 名英夫利西单抗使用者(平均年龄 45 岁)进行了研究。因感染住院的英夫利昔单抗使用者占 7%,依那西普使用者占 2%。比较生物仿制药和生物原研药的感染风险,依那西普的调整后危险比(95% 置信区间)为 1.33(0.77, 2.30),英夫利西单抗为 0.93(0.72, 1.18):我们的研究发现,依那西普和英夫利昔单抗生物仿制药与其生物原研药在感染发生率方面没有明显差异,这表明它们具有相似的安全性。
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Incidence of serious infection among etanercept and infliximab initiators: safety comparison between biosimilars and bio-originators with Canadian population-based data.

Background: Safety remains a significant concern for biologic drugs, and studies are needed to ensure a comparable safety profile for biosimilars and their legacy treatments. Using Canadian administrative health data from 2015-2019, we compared the incidence of serious infection between biosimilars and bio-originators initiators for etanercept and infliximab, two of the most commonly used biologics during this time.

Methods: We performed a retrospective cohort study using pan-Canadian data (except Quebec) from the National Prescription Drug Utilization Information System linked to hospitalization data. We studied new users of infliximab or etanercept (January/2015-December/2019) and compared incidence rates of serious infection, defined as those which required hospitalization, by using Cox regression models adjusted by biological sex, age at treatment initiation, prior corticosteroid or biologic, province, and calendar year.

Results: We studied 6,583 etanercept users (mean age 62) and 7,202 infliximab users (mean age 45). Hospitalization with infections occurred in 7% of infliximab and 2% of etanercept users. Comparing the risk of infection between biosimilar to bio-originator, the adjusted hazard ratio (95% confidence interval) was 1.33 (0.77, 2.30) for etanercept and 0.93 (0.72, 1.18) for infliximab.

Conclusions: Our study found no clear difference between etanercept and infliximab biosimilars and their bio-originators for infection incidence, suggesting a similar safety profile.

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来源期刊
BMC Rheumatology
BMC Rheumatology Medicine-Rheumatology
CiteScore
3.80
自引率
0.00%
发文量
73
审稿时长
15 weeks
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