Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, Université Paris Saclay, Le Kremlin Bicêtre, France.
Assitance-Publique-Hôpitaux de Paris, Hôpital Henri Mondor, Université Paris Est Créteil, Créteil, France.
Dig Liver Dis. 2020 Oct;52(10):1148-1155. doi: 10.1016/j.dld.2020.07.031. Epub 2020 Aug 20.
The aims of this study were to describe outcomes in patients with Crohn's disease who fail anti-tumor necrosis factor (TNF) and either vedolizumab or ustekinumab.
Multicenter, retrospective study of 100 patients with Crohn's disease who failed anti-TNF and either vedolizumab or ustekinumab from 2015 to 2019. Using multivariable Cox regression, we sought to identify factors associated with need for surgery.
75 patients received a third line treatment, resulting in 23 (30.7%) clinical remission at week 48. Among the 71 patients included after vedolizumab failure, 46 received ustekinumab, resulting in 46 (28.3%) clinical remission; 13 patients were retreated with an anti-TNF, resulting in 13 (46.2%) clinical remission. Among the 29 patients included after ustekinumab failure, 12 were retreated with an anti-TNF, resulting in 2 (16.7%) clinical remission. The rate of surgery-free survival at 48 weeks was 76.5% (95% confidence interval 68.4% - 85.4%). In multivariable analysis, ileal disease localization (hazard ratio 9.0, 95% confidence interval 1.0-81.9) was associated with a higher risk of surgery.
In patients with Crohn's disease who have failed anti-TNF and either vedolizumab or ustekinumab, at week 48, the surgery rate is 23.5% and the remission rate after a third line biologic therapy is 30.7%.
本研究旨在描述抗 TNF 治疗失败后转换为维得利珠单抗或乌司奴单抗的克罗恩病患者的结局。
这是一项多中心、回顾性研究，纳入了 2015 年至 2019 年期间抗 TNF 治疗失败后转换为维得利珠单抗或乌司奴单抗的 100 例克罗恩病患者。采用多变量 Cox 回归分析，我们旨在确定与手术需求相关的因素。
75 例患者接受了三线治疗，其中 23 例（30.7%）在第 48 周时达到临床缓解。在维得利珠单抗治疗失败的 71 例患者中，46 例接受了乌司奴单抗治疗，其中 46 例（28.3%）达到临床缓解；13 例患者再次接受抗 TNF 治疗，其中 13 例（46.2%）达到临床缓解。在乌司奴单抗治疗失败的 29 例患者中，12 例再次接受抗 TNF 治疗，其中 2 例（16.7%）达到临床缓解。第 48 周时无手术生存的比例为 76.5%（95%置信区间 68.4% - 85.4%）。多变量分析显示，回肠疾病定位（风险比 9.0，95%置信区间 1.0-81.9）与更高的手术风险相关。
在抗 TNF 治疗失败后转换为维得利珠单抗或乌司奴单抗的克罗恩病患者中，第 48 周时的手术率为 23.5%，三线生物治疗后的缓解率为 30.7%。
