Long-term clinical and endoscopic outcomes of ustekinumab in pediatric Crohn's disease with anti-tumor necrosis factor failure.

IF 3.7 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Journal of Gastroenterology and Hepatology Pub Date : 2024-11-04 DOI:10.1111/jgh.16790
Yoko Yamamoto, Ichiro Takeuchi, Hirotaka Shimizu, Hiroki Fujikawa, Masanori Toda, Eri Miyata, Hiroaki To, Satoru Nagata, Katsuhiro Arai
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Abstract

Background and aim: Only a few studies have reported the long-term effects of ustekinumab on pediatric Crohn's disease. Therefore, this study aimed to describe the long-term clinical and endoscopic outcomes of ustekinumab and its safety profile in pediatric-onset Crohn's disease with anti-tumor necrosis factor failure.

Methods: Medical records of patients with pediatric-onset Crohn's disease in whom anti-tumor necrosis factor therapy failed and ustekinumab treatment was initiated from 2017 to 2022 at a Japanese tertiary children's hospital were retrospectively reviewed. The primary outcome was the continuation rates at weeks 8, 52, and 106. The secondary outcomes were the steroid-free remission rates at weeks 8, 52, and 106, changes in the Simple Endoscopic Score for Crohn's Disease, and adverse events during follow-up.

Results: Forty-three patients were enrolled. The median ages at diagnosis and ustekinumab introduction were 9.7 (interquartile range: 6.7-13.0) years and 13.6 (interquartile range: 8.0-16.0) years. The median follow-up period was 136 (interquartile range: 102-172) weeks. The continuation rates were 100%, 91%, and 80% at weeks 8, 52, and 106, respectively. The incidence of discontinuation was 6.2% per patient-year of follow-up. The steroid-free remission rates were 44%, 71%, and 80% at weeks 8, 52, and 106, respectively. The Simple Endoscopic Score for Crohn's Disease of patients in clinical remission at the last follow-up significantly decreased (P < 0.01), and the safety profile was acceptable.

Conclusions: Ustekinumab appeared effective in maintaining long-term clinical remission with endoscopic improvement in pediatric-onset Crohn's disease with anti-tumor necrosis factor failure.

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乌司替库单抗治疗抗肿瘤坏死因子失败的小儿克罗恩病的长期临床和内镜疗效。
背景和目的:只有少数研究报道了乌司替尼对小儿克罗恩病的长期疗效。因此,本研究旨在描述乌斯特库单抗在抗肿瘤坏死因子治疗失败的儿科克罗恩病中的长期临床和内镜疗效及其安全性:回顾性研究了日本一家三级儿童医院2017年至2022年期间抗肿瘤坏死因子治疗失败并开始使用乌斯特库单抗治疗的儿科克罗恩病患者的病历。主要结果是第8周、第52周和第106周的持续率。次要结果是第8、52和106周的无类固醇缓解率、克罗恩病简易内镜评分的变化以及随访期间的不良事件:43名患者入选。诊断和使用乌司替尼时的中位年龄分别为 9.7 岁(四分位间距:6.7-13.0)和 13.6 岁(四分位间距:8.0-16.0)。中位随访时间为 136 周(四分位间范围:102-172 周)。第 8 周、第 52 周和第 106 周的持续率分别为 100%、91% 和 80%。每随访一年患者的停药率为 6.2%。在第 8 周、第 52 周和第 106 周,无类固醇缓解率分别为 44%、71% 和 80%。在最后一次随访中,临床缓解患者的克罗恩病简易内镜评分显著下降(P 结论:在最后一次随访中,临床缓解患者的克罗恩病简易内镜评分显著下降(P对于抗肿瘤坏死因子失效的儿科克罗恩病,优思明单抗似乎能有效维持长期临床缓解并改善内镜检查。
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来源期刊
CiteScore
7.90
自引率
2.40%
发文量
326
审稿时长
2.3 months
期刊介绍: Journal of Gastroenterology and Hepatology is produced 12 times per year and publishes peer-reviewed original papers, reviews and editorials concerned with clinical practice and research in the fields of hepatology, gastroenterology and endoscopy. Papers cover the medical, radiological, pathological, biochemical, physiological and historical aspects of the subject areas. All submitted papers are reviewed by at least two referees expert in the field of the submitted paper.
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