Severe Hypersensitivity Reactions at Biosimilar versus Originator Rituximab Treatment Initiation, Switch and Over Time: A Cohort Study on the French National Health Data System.
Hugo Jourdain, Léa Hoisnard, Emilie Sbidian, Mahmoud Zureik
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引用次数: 1
Abstract
Background: Biosimilar products of rituximab came to market in 2017. French pharmacovigilance centers have highlighted an excess of case reports of severe hypersensitivity reactions related to their use compared with the originator product.
Objective: The aim of this study was to assess the real-world association between biosimilar versus originator rituximab injections and hypersensitivity reactions, among initiators and switchers, at first injection and over time.
Methods: The French National Health Data System was used to identify all rituximab users between 2017 and 2021. A first cohort consisted of patients who initiated rituximab (originator or biosimilar), while a second cohort consisted of originator-to-biosimilar switchers, matched on age, sex, deliveries history, and pathology, with one or two patients still receiving the originator product. The event of interest was defined as a hospitalization for anaphylactic shock or serum sickness following a rituximab injection.
Results: A total of 91,894 patients were included in the initiation cohort-17,605 (19%) with the originator product and 74,289 (81%) with a biosimilar. At initiation, 86/17,605 (0.49%) and 339/74,289 (0.46%) events occurred in the originator and biosimilar groups, respectively. The adjusted odds ratio of biosimilar exposure associated with the event was 1.04 (95% confidence interval [CI] 0.80-1.34), and the adjusted hazard ratio for biosimilar versus originator exposure was 1.15 (95% CI 0.93-1.42), showing no increased risk of event with biosimilar use at first injection, and over time. 17,123 switchers were matched to 24,659 non-switchers. No association was found between switch to biosimilars and occurrence of the event.
Conclusion: Our study does not support any association between exposure to rituximab biosimilars versus originator and hospitalization for a hypersensitivity reaction, either at initiation, at switch, or over time.
背景:2017年美罗华生物类似药上市。法国药物警戒中心强调，与原产品相比，与使用它们相关的严重超敏反应病例报告过多。目的:本研究的目的是评估现实世界中生物仿制药与原始利妥昔单抗注射和过敏反应之间的关联，在首次注射和随着时间的推移，在启动者和切换者之间。方法:使用法国国家卫生数据系统识别2017年至2021年间所有利妥昔单抗使用者。第一个队列包括使用利妥昔单抗(原药或生物仿制药)的患者，而第二个队列包括在年龄、性别、分娩史和病理上匹配的原药到生物仿制药切换者，其中有一两个患者仍在使用原药产品。感兴趣的事件被定义为注射利妥昔单抗后因过敏性休克或血清疾病住院。结果:共有91,894名患者被纳入起始队列，其中17,605名(19%)患者使用原研产品，74289名(81%)患者使用生物仿制药。起始时，起始药组和生物仿制药组分别发生86/17,605(0.49%)和339/74,289(0.46%)事件。生物仿制药暴露与事件相关的调整优势比为1.04(95%可信区间[CI] 0.80-1.34)，生物仿制药与初始暴露的调整危险比为1.15 (95% CI 0.93-1.42)，表明首次注射生物仿制药和随着时间的推移，事件风险没有增加。17,123名转换者与24,659名非转换者相匹配。未发现改用生物仿制药与事件发生之间存在关联。结论:我们的研究不支持暴露于利妥昔单抗生物类似药与原药与因过敏反应住院之间的任何关联，无论是在起始、转换还是随着时间的推移。
期刊介绍：
An essential resource for R&D professionals and clinicians with an interest in biologic therapies.
BioDrugs covers the development and therapeutic application of biotechnology-based pharmaceuticals and diagnostic products for the treatment of human disease.
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