Park Jihye, Chun Jaeyoung, Yoon Hyuk, Cheon Jae Hee
Department of Internal Medicine, Sinchon Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Institute of Gastroenterology, Sinchon Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Inflamm Bowel Dis. 2023 Apr 3;29(4):548-554. doi: 10.1093/ibd/izac105.
Ustekinumab was recently approved for the treatment of moderate to severe Crohn's disease (CD). Although the ustekinumab Clinical Decision Support Tool (UST-CDST) was able to predict ustekinumab responsiveness in a clinical trial, it is not clear whether UST-CDST can also predict a future clinical relapse following ustekinumab therapy in the real-life setting.
We enrolled patients with moderate to severe CD who were refractory to conventional therapies and who showed a clinical response after induction therapy with ustekinumab and monitored them until the relapse. We performed a Cox proportional hazard analysis to investigate the predictive capability of UST-CDST for a clinical disease relapse.
Clinical remission rates at week 20 were 25.0% for low-probability responders, 66.7% for intermediate-probability responders, and 75.0% for high-probability responders. The high-probability responders were more likely to achieve clinical remission at week 20 compared with the low-probability responders. Among 99 patients with moderate to severe CD, 37 (37.4%) experienced a clinical relapse during the median follow-up period of 18.0 months of ustekinumab treatment. The cumulative relapse rates were 70.0% in the low-probability responders, 35.9% in the intermediate-probability responders, and 22.5% in the high-probability responders (P = .001). In a multivariable Cox proportional hazard analysis, the high-probability responders and intermediate-probability responders had a lower risk of clinical relapse than the low-probability responders. Receiver operating characteristic analysis using UST-CDST to predict relapse revealed an area under the curve of 0.698.
The UST-CDST can predict clinical relapse in patients with moderate to severe CD subjected to ustekinumab therapy.
乌司奴单抗最近被批准用于治疗中度至重度克罗恩病（CD）。尽管乌司奴单抗临床决策支持工具（UST-CDST）在一项临床试验中能够预测乌司奴单抗的反应性，但尚不清楚UST-CDST在现实环境中是否也能预测乌司奴单抗治疗后未来的临床复发。
我们纳入了对传统疗法难治且在接受乌司奴单抗诱导治疗后出现临床反应的中度至重度CD患者，并对他们进行监测直至复发。我们进行了Cox比例风险分析，以研究UST-CDST对临床疾病复发的预测能力。
低概率反应者在第20周时的临床缓解率为25.0%，中概率反应者为66.7%，高概率反应者为75.0%。与低概率反应者相比，高概率反应者在第20周时更有可能实现临床缓解。在99例中度至重度CD患者中，37例（37.4%）在乌司奴单抗治疗的中位随访期18.0个月内经历了临床复发。低概率反应者的累积复发率为70.0%，中概率反应者为35.9%，高概率反应者为22.5%（P = 0.001）。在多变量Cox比例风险分析中，高概率反应者和中概率反应者的临床复发风险低于低概率反应者。使用UST-CDST预测复发的受试者工作特征分析显示曲线下面积为0.698。
UST-CDST可以预测接受乌司奴单抗治疗的中度至重度CD患者的临床复发。
