Children's Hospital Los Angeles, Los Angeles, CA, USA.
University of California San Francisco, University of California San Francisco Benioff Children's Hospital, San Francisco, CA, USA.
Am J Health Syst Pharm. 2024 Jan 5;81(2):61-65. doi: 10.1093/ajhp/zxad217.
Biosimilar tumor necrosis factor inhibitors (b-TNFi) reduce healthcare costs and maintain equal efficacy when compared to their originator counterparts (o-TNFi). Current practice is to start patients on a slower standard infusion rate during the initial transition from an o-TNFi to a b-TNFi. There is a knowledge gap around switching from rapid originator infusion to rapid biosimilar infusion in the pediatric inflammatory bowel disease (IBD) population.
We present a case series of 8 pediatric patients with IBD who were switched from a rapid-infusion o-TNFi to a rapid-infusion b-TNFi from 2016 through 2022. Our primary interest was safety, which we evaluated based on the occurrence of infusion reactions or need for new premedications within the first 6 months of starting a b-TNFi. We also examined effectiveness through the incidence of IBD-related hospitalizations, TNFi failure, and need for co-medication or dose escalation over the same period. In our cohort, 4 patients had Crohn's disease and 4 had ulcerative colitis. All patients were switched to a biosimilar for nonmedical reasons. During the follow-up period, no patients had infusion reactions necessitating new premedications, serious adverse events, or medication nonresponse.
Patients who directly transitioned from a rapid-infusion o-TNFi to a rapid-infusion b-TNFi did not experience serious adverse events. Given the fiscal and patient experience advantages of rapid-rate infusions, larger studies are needed to consider a change in practice.
与原研肿瘤坏死因子抑制剂(o-TNFi)相比,生物类似物肿瘤坏死因子抑制剂(b-TNFi)可降低医疗成本并保持等效疗效。目前的做法是,在从 o-TNFi 转换为 b-TNFi 时,让患者在最初阶段以较慢的标准输注率开始。在儿科炎症性肠病(IBD)患者中,从快速原研输注转换为快速生物类似物输注的做法存在知识空白。
我们报告了 2016 年至 2022 年期间 8 例 IBD 儿科患者从快速输注 o-TNFi 转换为快速输注 b-TNFi 的病例系列。我们主要关注安全性,根据开始使用 b-TNFi 的前 6 个月内是否发生输注反应或需要新的预用药来评估安全性。我们还通过 IBD 相关住院、TNFi 治疗失败以及同期需要合并用药或剂量调整的发生率来评估有效性。在我们的队列中,4 例为克罗恩病,4 例为溃疡性结肠炎。所有患者均因非医疗原因转换为生物类似物。在随访期间,没有患者发生需要新预用药的输注反应、严重不良事件或药物无应答。
直接从快速输注 o-TNFi 转换为快速输注 b-TNFi 的患者未发生严重不良事件。鉴于快速输注在财政和患者体验方面的优势,需要进行更大规模的研究来考虑改变实践。