Nina K. Song BPharm (Hons), Hala Musa BSc (Hons), MSc, MPharm, Michael Soriano BS Pharmacy (PH), Mellissa Batger BSc, MPharm, Bryson Hawkins BPharm (Hons), Iqbal Ramzan Dip Pharmacy (NZ), MSc, PhD (USyd), David E. Hibbs BSc (Hons), PhD, Grad Cert Ed (Higher Ed), Jennifer A. Ong BPharm (Hons), PhD, Grad Cert Ed Studies(Higher Ed)
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引用次数: 1
摘要
目的比较利妥昔单抗生物类似药与利妥昔单抗对照药在肿瘤患者中的疗效和安全性。根据PRISMA指南进行系统评价和荟萃分析。检索MEDLINE、EMBASE和Cochrane Central数据库，从建立到2022年1月12日，获取所有报告利妥昔单抗生物类似药治疗癌症患者安全性和有效性结果的随机对照试验(rct)。所有在住院和门诊环境中进行的比较参考利妥昔单抗和生物仿制药的随机对照试验都被纳入系统评价。结果29项随机对照试验报告了利妥昔单抗治疗的患者。与对照组相比，接受利妥昔单抗生物类似药治疗的患者在至少24周的治疗中获得总缓解率的几率为1.06(95%可信区间[CI] 0.88-1.26)。两个研究组中出现任何治疗紧急不良事件的患者比例具有可比性(OR 1.20 [95% CI 0.98-1.49])。结论利妥昔单抗生物仿制药治疗naïve患者具有相当的疗效和安全性;然而，缺乏将患者从参考生物制剂转为生物类似药的有效性和安全性的证据，需要进一步研究。
Safety and efficacy comparisons of rituximab biosimilars to the reference product in patients with cancer: a systematic meta-analysis review
Aim
To compare the efficacy and safety of rituximab biosimilars to reference rituximab in patients with cancer.
Data Sources
A systematic review and meta-analysis was conducted in accordance with PRISMA guidelines. MEDLINE, EMBASE, and Cochrane Central databases were searched from inception to 12 January 2022 to obtain all randomised control trial (RCTs) reporting on the safety and efficacy outcomes of patients with cancer treated with rituximab biosimilars.
Study Selection
All RCTs comparing the reference rituximab with a biosimilar, conducted in inpatient and outpatient settings, were included in the systematic review.
Results
Twenty-nine RCTs were identified to report on patients treated with rituximab. The odds of achieving overall response rate in patients treated with a rituximab biosimilar compared to the reference over at least 24 weeks of treatment was 1.06 (95% confidence interval [CI] 0.88–1.26). The proportion of patients experiencing any treatment emergent adverse events were comparable between the two study arms (OR 1.20 [95% CI 0.98–1.49]).
Conclusion
Biosimilars for rituximab have comparable efficacy and safety profiles in treatment naïve patients; however, evidence for efficacy and safety of switching patients from reference biologic to biosimilar is lacking, and further research is required.
期刊介绍：
The purpose of this document is to describe the structure, function and operations of the Journal of Pharmacy Practice and Research, the official journal of the Society of Hospital Pharmacists of Australia (SHPA). It is owned, published by and copyrighted to SHPA. However, the Journal is to some extent unique within SHPA in that it ‘…has complete editorial freedom in terms of content and is not under the direction of the Society or its Council in such matters…’. This statement, originally based on a Role Statement for the Editor-in-Chief 1993, is also based on the definition of ‘editorial independence’ from the World Association of Medical Editors and adopted by the International Committee of Medical Journal Editors.
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