DataSheet1_Biosimilars in Pediatric Inflammatory Bowel Diseases: A Systematic Review and Real Life-Based Evidence.docx

Background: Many pediatric inflammatory bowel disease (IBD) patients are now using biosimilars of anti-tumor necrosis factor-α (TNF-α), with increasing trends in recent years. This study reviewed all available data regarding the use of biosimilars in children with IBD.Methods: PubMed, Google Scholar, Scopus, and CENTRAL databases were searched through keywords; inflammatory bowel diseases, Crohn’s disease, ulcerative colitis, biosimilar and child were combined using “AND” and “OR.” Original research articles involving pediatric patients receiving one of the biosimilar medications based on the anti-TNF-α biologic drugs approved for pediatric IBD treatment, independently from efficacy and drug response, were included.Results: Nine studies were included in the evidence synthesis. CT-P13 was the biosimilar used in all studies. Four studies assessed the induction effectiveness of CT-P13. Clinical response and remission rates of biosimilar treatment were 86–90% and 67–68%, respectively, and they were not significantly different to the originator group. Five prospective studies on patients elected to switch from originator IFX to CT-P13 yielded similar results. Adverse events related to CT-P13 were mostly mild. The most frequently reported were upper respiratory tract infections. The switch from the originator had no significant impact on immunogenicity.Conclusion: The current review showed reported CT-P13 effectiveness as measured by clinical response and/or remission rates after induction or during maintenance and suggest that there is no significant difference with that of the originator IFX. Further studies are warranted, including clinical, and pharmacovigilance studies.

背景：近年来，越来越多的儿科炎症性肠病（IBD）患者开始使用抗肿瘤坏死因子-α（TNF-α）的生物类似物，其使用趋势呈上升趋势。本研究回顾了所有关于儿童IBD患者使用生物类似物数据的可用信息。方法：通过PubMed、Google Scholar、Scopus和CENTRAL数据库，利用关键词检索，结合“AND”和“OR”将炎症性肠病、克罗恩病、溃疡性结肠炎、生物类似物和儿童进行组合，纳入了涉及接受抗TNF-α生物制剂的生物类似物药物治疗的儿科患者的原始研究文章，不受疗效和药物反应的影响。结果：纳入了九项研究的证据综合分析。CT-P13是所有研究中使用的生物类似物。其中四项研究评估了CT-P13的诱导治疗效果。生物类似物治疗的临床应答率和缓解率分别为86%-90%和67%-68%，与原研组相比，差异并不显著。五项针对选择从原研IFX切换至CT-P13的患者的前瞻性研究也产生了相似的结果。与CT-P13相关的副作用大多是轻微的，最常见的为上呼吸道感染。从原研药物切换至生物类似物对免疫原性没有显著影响。结论：本综述显示，根据诱导或维持治疗后的临床应答率和/或缓解率测量的CT-P13的有效性，并指出与原研IFX相比，并无显著差异。需要进一步的研究，包括临床研究和药物警戒研究。