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
{"title":"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。","authors":"Marina G Birck, Luck Lukusa, Denis Choquette, Gilles Boire, Walter P Maksymowych, Harminder Singh, Waqqas Afif, Sasha Bernatsky","doi":"10.1186/s41927-024-00415-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>Our study found no clear difference between etanercept and infliximab biosimilars and their bio-originators for infection incidence, suggesting a similar safety profile.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"8 1","pages":"47"},"PeriodicalIF":2.1000,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11441163/pdf/","citationCount":"0","resultStr":"{\"title\":\"Incidence of serious infection among etanercept and infliximab initiators: safety comparison between biosimilars and bio-originators with Canadian population-based data.\",\"authors\":\"Marina G Birck, Luck Lukusa, Denis Choquette, Gilles Boire, Walter P Maksymowych, Harminder Singh, Waqqas Afif, Sasha Bernatsky\",\"doi\":\"10.1186/s41927-024-00415-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>Our study found no clear difference between etanercept and infliximab biosimilars and their bio-originators for infection incidence, suggesting a similar safety profile.</p>\",\"PeriodicalId\":9150,\"journal\":{\"name\":\"BMC Rheumatology\",\"volume\":\"8 1\",\"pages\":\"47\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2024-09-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11441163/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Rheumatology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1186/s41927-024-00415-5\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"RHEUMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Rheumatology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s41927-024-00415-5","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}
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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
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
期刊最新文献
Association between osteoprotegerin and RANKL single nucleotide polymorphisms and destructive rhinosinusitis in patients with granulomatosis with polyangiitis. Thermographic and ultrasound assessment in patients with rheumatoid arthritis: can thermography detect subclinical synovitis at the wrist? Rheumatoid arthritis and COVID-19 outcomes: a systematic review and Meta-analysis. Classification of salivary gland biopsies in Sjögren's syndrome by a convolutional neural network using an auto-machine learning platform. Prevalence of co-existing autoimmune and autoinflammatory diseases in vitiligo: a survey-based study from Egypt.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1