Maltz Ross M, Saeed Shehzad A, Adler Jeremy
Department of Pediatrics, The Ohio State University Wexner Medical Center, Columbus, OH 43210, USA.
Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Nationwide Children's Hospital, Columbus, OH 43205, USA.
Children (Basel). 2025 May 20;12(5):656. doi: 10.3390/children12050656.
: Infliximab biosimilars entered the United States (US) market in November 2016. Uptake of infliximab biosimilars has been slow in adult studies. We aimed to assess variation in the initiation of infliximab biosimilars in a large pediatric cohort. : We performed a retrospective cohort study using data from 2016 to 2023 prospectively collected by the ImproveCareNow (ICN) Network, a multicenter pediatric inflammatory bowel disease (IBD) quality improvement collaborative. Pediatric patients with IBD who started any infliximab therapy were included. Descriptive statistics were used to summarize patient characteristics and changes in the use of infliximab agents. Chi-square or Fisher's exact tests were used to evaluate differences in infliximab biosimilar initiation over time by race, age, ethnicity, and region. : In total, 4602 patients from 73 ICN centers started an infliximab agent. Infliximab biosimilar initiation rose steadily from 1% in 2018 to nearly 42% in 2023, with 88% of centers using biosimilars in 2023. Overall, from 2016 to 2023, the total percentage of patients who were started on an infliximab biosimilar was 17.3%. There were no differences in infliximab biosimilar initiation by age, race, or ethnicity, except in 2020 for age and race. The Midwest, West, and Southwest regions had higher initiation rates of infliximab biosimilars than the rest of the US. : The percentage of patients with IBD initiating an infliximab biosimilar rose slowly to nearly 42% by 2023, and eight (12%) centers never recorded prescribing an infliximab biosimilar in the ICN Network. There were no differences in biosimilar initiation based on race or ethnicity.
英夫利昔单抗生物类似药于2016年11月进入美国市场。在成人研究中,英夫利昔单抗生物类似药的使用增长缓慢。我们旨在评估一大群儿科患者中开始使用英夫利昔单抗生物类似药的差异。
我们进行了一项回顾性队列研究,使用了ImproveCareNow(ICN)网络前瞻性收集的2016年至2023年的数据,该网络是一个多中心儿科炎症性肠病(IBD)质量改进协作组织。纳入开始任何英夫利昔单抗治疗的儿科IBD患者。描述性统计用于总结患者特征和英夫利昔单抗药物使用的变化。卡方检验或费舍尔精确检验用于评估按种族、年龄、民族和地区划分的英夫利昔单抗生物类似药起始使用随时间的差异。
总共有来自73个ICN中心的4602名患者开始使用英夫利昔单抗药物。英夫利昔单抗生物类似药的起始使用率从2018年的1%稳步上升至2023年的近42%,2023年有88%的中心使用生物类似药。总体而言,从2016年到2023年,开始使用英夫利昔单抗生物类似药的患者总百分比为17.3%。除2020年年龄和种族存在差异外,按年龄、种族或民族划分的英夫利昔单抗生物类似药起始使用没有差异。美国中西部、西部和西南部地区的英夫利昔单抗生物类似药起始使用率高于美国其他地区。
到2023年,开始使用英夫利昔单抗生物类似药的IBD患者百分比缓慢上升至近42%,并且在ICN网络中有八个(12%)中心从未记录过开具英夫利昔单抗生物类似药的处方。基于种族或民族的生物类似药起始使用没有差异。