CHU Rennes, University Rennes, 35000, Rennes, France.
CHU Lille, University of Lille, Lille, France.
BMC Gastroenterol. 2022 Dec 1;22(1):498. doi: 10.1186/s12876-022-02583-5.
No study has performed a face-to-face comparison of biologics after the failure of the first anti-TNF agent in patients with Crohn's disease (CD). The aim of the study was to compare the efficacy of biologics in this setting.
Patients with CD who were refractory to a first anti-TNF agent, and treated with ustekinumab (UST), vedolizumab (VDZ), or a second anti-TNF drug as a second-line biological agent at 10 French tertiary centres from 2013 to 2019 were retrospectively included in this study.
Among the 203 patients included, 90 (44%) received UST, 42 (21%) received VDZ and 71 (35%) received a second anti-TNF agent. The first anti-TNF agent was discontinued due to a primary nonresponse in 42 (21%) patients. At weeks 14-24, the rates of steroid-free remission were similar between the UST, VDZ and second anti-TNF groups (29%, 38% and 44%, respectively, p = 0.15). With a mean follow-up of 118 weeks, drug survival was shorter for patients who received ustekinumab treatment (p = 0.001). In the case of trough level less than 5 µg/ml, patients treated with a second anti-TNF agent had a higher postinduction remission rate (p = 0.002), and drug survival (p = 0.0005). No other relevant factors were associated with treatment efficacy, including trough levels greater than 5 µg/ml.
VDZ, UST and a second anti-TNF agent exhibit similar efficacy in the short term, as second-biological line treatment in patients with CD who are refractory to a first anti-TNF agent, but shorter drug maintenance is observed for patients treated with UST.
尚无研究对克罗恩病（CD）患者中首用抗 TNF 药物失败后的生物制剂进行面对面比较。本研究旨在比较该背景下生物制剂的疗效。
本回顾性研究纳入了 2013 年至 2019 年来自 10 家法国三级中心的难治性 CD 患者，这些患者在首用抗 TNF 药物后接受乌司奴单抗（UST）、维得利珠单抗（VDZ）或二线抗 TNF 药物作为二线生物制剂治疗。
203 例患者中，90 例（44%）接受 UST，42 例（21%）接受 VDZ，71 例（35%）接受二线抗 TNF 药物。42 例（21%）患者因原发性无应答而停用首用 TNF 药物。在第 14-24 周，UST、VDZ 和二线抗 TNF 组的无激素缓解率相似（分别为 29%、38%和 44%，p=0.15）。中位随访 118 周时，UST 治疗患者的药物存活率更短（p=0.001）。在谷浓度＜5μg/ml 的情况下，接受二线抗 TNF 药物治疗的患者诱导缓解后缓解率更高（p=0.002），药物存活率更高（p=0.0005）。其他与治疗效果相关的因素，包括谷浓度＞5μg/ml，与疗效无关。
在首用抗 TNF 药物失败的 CD 患者中，VDZ、UST 和二线抗 TNF 药物作为二线生物制剂短期疗效相似，但 UST 治疗患者的药物维持时间更短。
