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炎症性肠病患儿中从快速输注原研药到快速输注生物类似物肿瘤坏死因子抑制剂的直接转换:病例系列研究。

Direct transition from rapid-infusion originator to rapid-infusion biosimilar tumor necrosis factor inhibitor in children with inflammatory bowel disease: A case series.

机构信息

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.

出版信息

Am J Health Syst Pharm. 2024 Jan 5;81(2):61-65. doi: 10.1093/ajhp/zxad217.

Abstract

PURPOSE

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.

SUMMARY

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.

CONCLUSION

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.

摘要

目的

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。

摘要

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。

结论

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。

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Biological therapy in pediatric age.儿童时期的生物治疗。
Pharmacol Res. 2020 Nov;161:105120. doi: 10.1016/j.phrs.2020.105120. Epub 2020 Aug 9.
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ACG Clinical Guideline: Ulcerative Colitis in Adults.ACG 临床指南:成人溃疡性结肠炎。
Am J Gastroenterol. 2019 Mar;114(3):384-413. doi: 10.14309/ajg.0000000000000152.

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