在先前剂量升级后，对炎症性肠病患者进行生物治疗的降级。

De-escalation of biological therapy in inflammatory bowel disease patients following prior dose escalation.

机构信息

Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen.

Department of Gastroenterology and Hepatology, Franciscus Gasthuis & Vlietland, Rotterdam.

出版信息

Eur J Gastroenterol Hepatol. 2022 May 1;34(5):488-495. doi: 10.1097/MEG.0000000000002336.

DOI:10.1097/MEG.0000000000002336

PMID:34974465

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8983943/

Abstract

BACKGROUND

Limited data are available on biological therapy de-escalation after prior escalation in inflammatory bowel disease (IBD) patients. This study aimed to assess the frequency and success rate of de-escalation of biological therapy in IBD patients after prior dose escalation and to evaluate which measures are used to guide de-escalation.

METHODS

This multicentre retrospective cohort study enrolled IBD patients treated with infliximab (IFX), adalimumab (ADA) or vedolizumab (VEDO) in whom therapy was de-escalated after prior biological escalation. De-escalations were considered pharmacokinetic-driven if based on clinical symptoms combined with therapeutic or supratherapeutic trough levels, and disease activity-driven if based on faecal calprotectin less than or equal to 200 µg/g or resolution of perianal fistula drainage or closure or endoscopic remission. Successful de-escalation was defined as remaining on the same or lower biological dose for greater than or equal to 6 months after de-escalation without the need for corticosteroids.

RESULTS

In total, 206 IFX users, 85 ADA users and 55 VEDO users underwent therapy escalation. Of these patients, 34 (17%) on IFX, 18 (21%) on ADA and 8 (15%) on VEDO underwent therapy de-escalation. De-escalation was successful in 88% of IFX patients, 89% of ADA and 100% of VEDO. The probability of remaining on the de-escalated regimen or further de-escalation after 1 year was 85% for IFX, 62% for ADA and 100% for VEDO. Disease activity-driven de-escalations were more often successful (97%) than pharmacokinetic- and no marker-driven de-escalations (76%); P = 0.017.

CONCLUSION

De-escalation after biological dose escalation was successful in the majority of carefully selected IBD patients. Objective assessment of remission increased the likelihood of successful de-escalation.

摘要

背景

炎症性肠病（IBD）患者在接受生物制剂升级治疗后，关于降级治疗的数据有限。本研究旨在评估 IBD 患者在经历过剂量升级后进行生物制剂降级治疗的频率和成功率，并评估哪些措施可用于指导降级治疗。

方法

这是一项多中心回顾性队列研究，纳入了接受英夫利昔单抗（IFX）、阿达木单抗（ADA）或维得利珠单抗（VEDO）治疗的 IBD 患者，这些患者在经历过生物制剂升级治疗后进行了降级治疗。如果降级是基于临床症状结合治疗或超治疗谷浓度，那么被认为是基于药代动力学的；如果降级是基于粪便钙卫蛋白≤200μg/g 或肛周瘘管引流或闭合或内镜缓解，那么被认为是基于疾病活动度的。成功的降级定义为在降级后至少 6 个月内继续使用相同或更低剂量的生物制剂，而无需使用皮质类固醇。

结果

共有 206 例 IFX 使用者、85 例 ADA 使用者和 55 例 VEDO 使用者接受了治疗升级。在这些患者中，有 34 例（17%）IFX、18 例（21%）ADA 和 8 例（15%）VEDO 进行了治疗降级。IFX 患者中 88%、ADA 患者中 89%和 VEDO 患者中 100%的降级治疗是成功的。IFX 患者在 1 年后继续使用降级方案或进一步降级的概率为 85%，ADA 患者为 62%，VEDO 患者为 100%。基于疾病活动度的降级治疗（97%）比基于药代动力学和无标志物的降级治疗（76%）更成功；P=0.017。