Birck Marina G, Lukusa Luck, Choquette Denis, Boire Gilles, Maksymowych Walter P, Singh Harminder, Afif Waqqas, Bernatsky Sasha
Research Institute of the McGill University Health Centre, Montreal, QC, Canada.
McGill University, Montreal, QC, Canada.
BMC Rheumatol. 2024 Sep 27;8(1):47. doi: 10.1186/s41927-024-00415-5.
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.
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.
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.
Our study found no clear difference between etanercept and infliximab biosimilars and their bio-originators for infection incidence, suggesting a similar safety profile.
生物药物的安全性仍是一个重大问题，需要开展研究以确保生物类似药及其原研药物具有可比的安全性。利用加拿大2015年至2019年的行政卫生数据，我们比较了依那西普和英夫利昔单抗（这一时期最常用的两种生物制剂）生物类似药和原研药起始使用者严重感染的发生率。
我们使用来自国家处方药利用信息系统的全加拿大数据（魁北克除外）并链接住院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的新使用者（2015年1月/2019年12月），并通过使用按生物学性别、治疗起始年龄、既往使用皮质类固醇或生物制剂、省份和日历年调整的Cox回归模型比较了需要住院治疗的严重感染的发生率。
我们研究了6583名依那西普使用者（平均年龄62岁）和7202名英夫利昔单抗使用者（平均年龄45岁）。英夫利昔单抗使用者中有7%因感染住院，依那西普使用者中有2%因感染住院。比较生物类似药与原研药之间的感染风险，依那西普的调整后风险比（95%置信区间）为1.33（0.77，2.30），英夫利昔单抗为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类似药与其原研药在感染发生率方面没有明显差异，表明具有相似的安全性。
