Aurélio Matos Andrade, Juliana da Motta Girardi, Erica Tatiane da Silva, Jakeline Ribeiro Barbosa, Daniella Cristina Rodrigues Pereira
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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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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<sup>2</sup> 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.</p><p><strong>Conclusions: </strong>Thus, this review found that biosimilar etanercept had efficacy, safety, and immunogenicity similar to those for the biological reference.</p><p><strong>Systematic review registration: </strong>This systematic review was registered on the PROSPERO platform under number CRD42020166610.</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"291"},"PeriodicalIF":6.3000,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11600673/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy, safety, and immunogenicity of biosimilars compared with the biologic etanercept in patients with rheumatoid arthritis: a systematic review and meta-analysis.\",\"authors\":\"Aurélio Matos Andrade, Juliana da Motta Girardi, Erica Tatiane da Silva, Jakeline Ribeiro Barbosa, Daniella Cristina Rodrigues Pereira\",\"doi\":\"10.1186/s13643-024-02715-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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. 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引用次数: 0
摘要
背景：生物仿制药依那普利（etanercept）是治疗炎症性和自身免疫性疾病的一种创新疗法，但它与治疗类风湿性关节炎的参照生物制剂相比，在疗效、安全性和免疫原性方面仍存在疑问。有鉴于此，本研究旨在验证生物仿制药 etanercept 与参考生物制剂在 18 岁以上类风湿关节炎患者中的疗效、安全性和免疫原性：根据《系统综述和荟萃分析首选报告项目》（Preferred Reporting Items for Systematic Reviews and Meta-Analyses，PRISMA）的参数，仅选择 III 期随机临床试验进行了系统综述和荟萃分析。检索策略以 "Etanercept"、"生物制品"、"类风湿关节炎"、"生物类似药 "为 MeSH 词，于 2023 年 1 月通过 PubMed、Embase、Cochrane 图书馆、Web of Science、EBSCO 和 Lilacs 在 Medline 上进行了检索。分析指标为二分法数据的相对风险（RR）和连续法数据的平均差（MD）。编制荟萃分析的统计分析由 Review Manager 5.1.4 软件开发：本系统综述选择了 6 项符合条件的研究，样本人数为 2355 人。主要疗效结果显示，这两种药物在6个月内的ACR20、ACR50和ACR70反应方面均无统计学显著差异（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，分别为55%至63%和0.04≤P≥0.08），I2为55%至63%。不良反应多为轻度或中度，严重不良反应无统计学意义。在免疫原性方面，ADA阳性的生物类似物组中只有5.4%的人中和抗体呈阳性：因此，本综述发现生物仿制药依那西普的疗效、安全性和免疫原性与生物参照药相似：本系统综述已在 PROSPERO 平台注册，注册号为 CRD42020166610。
Efficacy, safety, and immunogenicity of biosimilars compared with the biologic etanercept in patients with rheumatoid arthritis: a systematic review and meta-analysis.
Background: 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.
Methods: 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.
Results: 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 I2 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.
Conclusions: Thus, this review found that biosimilar etanercept had efficacy, safety, and immunogenicity similar to those for the biological reference.
Systematic review registration: This systematic review was registered on the PROSPERO platform under number CRD42020166610.
期刊介绍：
Systematic Reviews encompasses all aspects of the design, conduct and reporting of systematic reviews. The journal publishes high quality systematic review products including systematic review protocols, systematic reviews related to a very broad definition of health, rapid reviews, updates of already completed systematic reviews, and methods research related to the science of systematic reviews, such as decision modelling. At this time Systematic Reviews does not accept reviews of in vitro studies. The journal also aims to ensure that the results of all well-conducted systematic reviews are published, regardless of their outcome.
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