Medical Sciences Program, University of Brasília (UnB), Brasília, DF, 70.910-900, Brazil.
Program of Evidence for Health Policy and Technologies, Oswaldo Cruz Foundation- Fiocruz Brasília, DF, 70.910-900, Brazil.
Syst Rev. 2024 Nov 27;13(1):291. doi: 10.1186/s13643-024-02715-w.
Biosimilar etanercept presents itself as an innovative therapeutic opportunity for inflammatory and autoimmune diseases, however, its efficacy, safety, and immunogenicity in relation to the reference biological agent for the treatment of rheumatoid arthritis is still questioned. With this in mind, this study aimed to verify the efficacy, safety, and immunogenicity of the use of the biosimilar etanercept in relation to the reference biologic in patients over 18 years of age with rheumatoid arthritis.
A systematic review with meta-analysis was performed in accordance with the parameters of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) selecting only Phase III randomized clinical trials. The search strategy was constructed with the MeSH terms "Etanercept", "Biological Products", "Arthritis, Rheumatoid", "Biosimilar Pharmaceuticals" and was performed in Medline via PubMed, Embase, the Cochrane Library, Web of Science, EBSCO and Lilacs in January 2023. The analysis measures were relative risk (RR) for dichotomous data and mean difference (MD) for continuous data. The statistical analysis for preparing meta-analyses was developed by the Review Manager 5.1.4 software.
This systematic review selected 6 eligible studies with a sample population of n = 2355. The main efficacy outcomes showed that both drugs did not present statistically significant differences in ACR20, ACR50, and ACR70 responses within 6 months (RR 1.00; 95% CI = 0.94 to 1.07; RR 1.09; 95% CI = 0.94 to 1.26; RR 1.04; 95% CI = 0.82 to 1.31, respectively), with I ranging from 55 to 63% and 0.04 ≤ P ≥ 0.08. Adverse events were mostly mild or moderate, and serious adverse events were not statistically significant. Regarding immunogenicity, only 5.4% of the ADA-positive biosimilar group had positive neutralizing antibodies.
Thus, this review found that biosimilar etanercept had efficacy, safety, and immunogenicity similar to those for the biological reference.
This systematic review was registered on the PROSPERO platform under number CRD42020166610.
生物类似物依那西普为炎症性和自身免疫性疾病提供了一种创新性的治疗机会，然而，其在治疗类风湿关节炎方面相对于参考生物制剂的疗效、安全性和免疫原性仍存在争议。考虑到这一点，本研究旨在验证生物类似物依那西普在 18 岁以上类风湿关节炎患者中的疗效、安全性和免疫原性是否与参考生物制剂相当。
按照系统评价和荟萃分析的首选报告项目（PRISMA）参数进行系统评价和荟萃分析，仅选择 III 期随机临床试验。检索策略使用 MeSH 术语“Etanercept”、“Biological Products”、“Arthritis, Rheumatoid”、“Biosimilar Pharmaceuticals”，通过 PubMed 中的 Medline、Embase、Cochrane 图书馆、Web of Science、EBSCO 和 Lilacs 于 2023 年 1 月进行检索。分析指标为二分类数据的相对风险（RR）和连续数据的均数差（MD）。准备荟萃分析的统计分析由 Review Manager 5.1.4 软件完成。
本系统评价共纳入 6 项符合条件的研究，样本量为 n=2355。主要疗效结局显示，两种药物在 6 个月内 ACR20、ACR50 和 ACR70 反应方面均无统计学差异（RR 1.00；95%CI=0.94 至 1.07；RR 1.09；95%CI=0.94 至 1.26；RR 1.04；95%CI=0.82 至 1.31），I ²值为 55%至 63%，0.04≤P≥0.08。不良事件多为轻度或中度，严重不良事件无统计学意义。关于免疫原性，只有 5.4%的 ADA 阳性生物类似物组出现了中和抗体阳性。
因此，本综述发现，生物类似物依那西普在疗效、安全性和免疫原性方面与参考生物制剂相似。
本系统评价在 PROSPERO 平台上以编号 CRD42020166610 进行注册。
