抗肿瘤坏死因子-α生物类似药治疗青少年特发性关节炎的疗效和安全性——一项系统综述和荟萃分析

IF 4.4 2区医学 Q1 RHEUMATOLOGY

Seminars in arthritis and rheumatism Pub Date : 2025-07-16 DOI:10.1016/j.semarthrit.2025.152792

Junjie Huang , Kai Liang Teh , Chunliang Chen , Lena Das , Thaschawee Arkachaisri

{"title":"抗肿瘤坏死因子-α生物类似药治疗青少年特发性关节炎的疗效和安全性——一项系统综述和荟萃分析","authors":"Junjie Huang , Kai Liang Teh , Chunliang Chen , Lena Das , Thaschawee Arkachaisri","doi":"10.1016/j.semarthrit.2025.152792","DOIUrl":null,"url":null,"abstract":"<div><h3>Objectives</h3><div>Anti-Tumor Necrosis Factor-α (aTNF) biologics have transformed the management of Juvenile Idiopathic Arthritis (JIA), but their high-cost limits access. Biosimilars provide an affordable alternative. We aimed to summarize the data on the efficacy and safety profiles of aTNF biosimilars in JIA.</div></div><div><h3>Methods</h3><div>A systematic search was conducted through the Cochrane Library, Embase, PubMed, Scopus, and Web of Science. Studies evaluating the use of aTNF biosimilars in JIA patients compared against originators or placebo, published from inception to 30th August 2024, were included. Quality of included studies was assessed by the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool. Efficacy and safety outcomes were summarized descriptively, and meta-analysis was performed where appropriate. (PROSPERO Registration ID: CRD42024523627)</div></div><div><h3>Results</h3><div>Five observational studies were identified. Risk of bias was assessed to be serious in all studies. All but one study showed no significant difference between biosimilars and originators in head-to-head comparisons of disease activity measured using Juvenile Arthritis Disease Activity Scores (JADAS). In two studies on switching of originators to biosimilars, disease activities remained stable after switch until the end of study follow-up. Adverse events were similar between biosimilars and originators (OR 0.78, 95%CI: 0.52-1.17).</div></div><div><h3>Conclusion</h3><div>Biosimilars and originators of aTNF are similar in efficacy and safety in pediatric patients with JIA. However, there is a lack of high-quality studies. This review should be updated as more studies become available.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"74 ","pages":"Article 152792"},"PeriodicalIF":4.4000,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of anti-Tumor Necrosis Factor-α biosimilars in Juvenile Idiopathic Arthritis - a systematic review and meta-analysis\",\"authors\":\"Junjie Huang , Kai Liang Teh , Chunliang Chen , Lena Das , Thaschawee Arkachaisri\",\"doi\":\"10.1016/j.semarthrit.2025.152792\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objectives</h3><div>Anti-Tumor Necrosis Factor-α (aTNF) biologics have transformed the management of Juvenile Idiopathic Arthritis (JIA), but their high-cost limits access. Biosimilars provide an affordable alternative. We aimed to summarize the data on the efficacy and safety profiles of aTNF biosimilars in JIA.</div></div><div><h3>Methods</h3><div>A systematic search was conducted through the Cochrane Library, Embase, PubMed, Scopus, and Web of Science. Studies evaluating the use of aTNF biosimilars in JIA patients compared against originators or placebo, published from inception to 30th August 2024, were included. Quality of included studies was assessed by the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool. Efficacy and safety outcomes were summarized descriptively, and meta-analysis was performed where appropriate. (PROSPERO Registration ID: CRD42024523627)</div></div><div><h3>Results</h3><div>Five observational studies were identified. Risk of bias was assessed to be serious in all studies. All but one study showed no significant difference between biosimilars and originators in head-to-head comparisons of disease activity measured using Juvenile Arthritis Disease Activity Scores (JADAS). In two studies on switching of originators to biosimilars, disease activities remained stable after switch until the end of study follow-up. Adverse events were similar between biosimilars and originators (OR 0.78, 95%CI: 0.52-1.17).</div></div><div><h3>Conclusion</h3><div>Biosimilars and originators of aTNF are similar in efficacy and safety in pediatric patients with JIA. However, there is a lack of high-quality studies. This review should be updated as more studies become available.</div></div>\",\"PeriodicalId\":21715,\"journal\":{\"name\":\"Seminars in arthritis and rheumatism\",\"volume\":\"74 \",\"pages\":\"Article 152792\"},\"PeriodicalIF\":4.4000,\"publicationDate\":\"2025-07-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Seminars in arthritis and rheumatism\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0049017225001635\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"RHEUMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Seminars in arthritis and rheumatism","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0049017225001635","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

目的抗肿瘤坏死因子-α (aTNF)生物制剂已经改变了青少年特发性关节炎（JIA）的治疗方式，但其高昂的成本限制了其可及性。生物仿制药提供了一种负担得起的替代方案。我们旨在总结aTNF生物类似药在JIA中的疗效和安全性数据。方法通过Cochrane Library、Embase、PubMed、Scopus、Web of Science进行系统检索。纳入了从开始到2024年8月30日发表的评估aTNF生物类似药在JIA患者中与原药或安慰剂相比使用的研究。纳入研究的质量通过非随机干预研究的偏倚风险（ROBINS-I）工具进行评估。对疗效和安全性结果进行描述性总结，并在适当的地方进行meta分析。（PROSPERO Registration ID: CRD42024523627）结果纳入了5项观察性研究。所有研究的偏倚风险均被评估为严重。除一项研究外，所有研究均显示生物仿制药和原研药在使用青少年关节炎疾病活动性评分（JADAS）测量的疾病活动性的正面比较中没有显著差异。在两项将原研药转换为生物仿制药的研究中，疾病活动在转换后保持稳定，直到研究随访结束。不良事件在生物仿制药和原研药之间相似（OR 0.78, 95%CI: 0.52-1.17）。结论aTNF的生物类似药和原研药在小儿JIA患者的疗效和安全性方面相似。然而，缺乏高质量的研究。随着更多研究的出现，本综述应进行更新。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Efficacy and safety of anti-Tumor Necrosis Factor-α biosimilars in Juvenile Idiopathic Arthritis - a systematic review and meta-analysis

查看原文本刊更多论文

Efficacy and safety of anti-Tumor Necrosis Factor-α biosimilars in Juvenile Idiopathic Arthritis - a systematic review and meta-analysis

Objectives

Anti-Tumor Necrosis Factor-α (aTNF) biologics have transformed the management of Juvenile Idiopathic Arthritis (JIA), but their high-cost limits access. Biosimilars provide an affordable alternative. We aimed to summarize the data on the efficacy and safety profiles of aTNF biosimilars in JIA.

Methods

A systematic search was conducted through the Cochrane Library, Embase, PubMed, Scopus, and Web of Science. Studies evaluating the use of aTNF biosimilars in JIA patients compared against originators or placebo, published from inception to 30th August 2024, were included. Quality of included studies was assessed by the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool. Efficacy and safety outcomes were summarized descriptively, and meta-analysis was performed where appropriate. (PROSPERO Registration ID: CRD42024523627)

Results

Five observational studies were identified. Risk of bias was assessed to be serious in all studies. All but one study showed no significant difference between biosimilars and originators in head-to-head comparisons of disease activity measured using Juvenile Arthritis Disease Activity Scores (JADAS). In two studies on switching of originators to biosimilars, disease activities remained stable after switch until the end of study follow-up. Adverse events were similar between biosimilars and originators (OR 0.78, 95%CI: 0.52-1.17).

Conclusion

Biosimilars and originators of aTNF are similar in efficacy and safety in pediatric patients with JIA. However, there is a lack of high-quality studies. This review should be updated as more studies become available.

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

Seminars in arthritis and rheumatism 医学-风湿病学

CiteScore

9.20

自引率

4.00%

发文量

176

审稿时长

46 days

期刊介绍： Seminars in Arthritis and Rheumatism provides access to the highest-quality clinical, therapeutic and translational research about arthritis, rheumatology and musculoskeletal disorders that affect the joints and connective tissue. Each bimonthly issue includes articles giving you the latest diagnostic criteria, consensus statements, systematic reviews and meta-analyses as well as clinical and translational research studies. Read this journal for the latest groundbreaking research and to gain insights from scientists and clinicians on the management and treatment of musculoskeletal and autoimmune rheumatologic diseases. The journal is of interest to rheumatologists, orthopedic surgeons, internal medicine physicians, immunologists and specialists in bone and mineral metabolism.