Background While randomized controlled trials have shown ustekinumab (UST) as an effective therapeutic option for Crohn’s disease (CD), there is a lack of long-term observational data in real-world CD patient settings. This prospective study seeks to evaluate the clinical effectiveness, sustainability, and safety of UST in a nationwide multicentre cohort of CD patients over three years. The aim is to bridge the gap in our understanding of UST's real-world implications for long-term CD management. Methods CD patients undergoing ustekinumab (UST) treatment were consecutively enrolled at nine Hungarian Inflammatory Bowel Disease centers from January 2019 to May 2020. Over a three-year period, comprehensive data on patient demographics, disease characteristics, treatment history, clinical disease activity (measured by the Harvey Bradshaw Index (HBI)), biomarkers, and endoscopic activity (evaluated using the Simple Endoscopic Score for Crohn’s Disease (SES-CD)) were systematically collected. Results Involving 148 patients, the cohort comprised 48.9% with complex behavior of CD and 97.2% with previous anti-TNF exposure. Pre-induction remission rates were observed at 12.2% (HBI) and 5.1% (SES-CD). Clinical remission rates (HBI) at the end of the first, second, and third years were 52.2%, 55.6%, and 50.9%, respectively. Criteria for endoscopic remission were met in 14.3%, 27.5%, and 35.3% of subjects at the end of the first, second, and third years. Dose intensification was notable, with 84.0% of patients on an 8-weekly and 29.9% on a 4-weekly regimen by the end of year 3. Throughout the follow-up period, drug sustainability stood at 76.9%, and no serious adverse events were observed. Conclusion Our study confirms that ustekinumab is a sustainable, effective, and safe long-term treatment for Crohn's disease patients with a severe disease phenotype and a history of high anti-TNF failure, with the need for frequent dose adjustments.

中文翻译：

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P661 乌司奴单抗治疗克罗恩病：来自匈牙利的一项为期三年的多中心前瞻性研究 - 评估疗效、药物可持续性和安全性

背景 虽然随机对照试验表明乌特克单抗 (UST) 是克罗恩病 (CD) 的有效治疗选择，但在现实世界的 CD 患者环境中缺乏长期观察数据。这项前瞻性研究旨在评估 UST 在三年多的全国多中心 CD 患者队列中的临床有效性、可持续性和安全性。目的是弥合我们对 UST 对长期 CD 管理的现实影响的理解差距。方法 2019 年 1 月至 2020 年 5 月，连续入组匈牙利 9 个炎症性肠病中心接受乌特克单抗 (UST) 治疗的 CD 患者。在三年期间，收集了有关患者人口统计数据、疾病特征、治疗史、临床疾病活动度（测量值）的综合数据。系统地收集了哈维布拉德肖指数（HBI））、生物标志物和内窥镜活动（使用克罗恩病简单内窥镜评分（SES-CD）进行评估）。结果 该队列涉及 148 名患者，其中 48.9% 患有 CD 复杂行为，97.2% 曾接触过抗 TNF 药物。观察到诱导前缓解率为 12.2% (HBI) 和 5.1% (SES-CD)。第一年、第二年和第三年末的临床缓解率 (HBI) 分别为 52.2%、55.6% 和 50.9%。第一年、第二年和第三年末，分别有 14.3%、27.5% 和 35.3% 的受试者达到内镜缓解标准。剂量强化效果显着，到第 3 年年底，84.0% 的患者接受每周 8 次治疗，29.9% 的患者接受每周 4 周治疗。在整个随访期间，药物可持续性为 76.9%，并且没有严重不良事件被观察到。结论 我们的研究证实，乌特克单抗对于具有严重疾病表型和高抗 TNF 失败史且需要频繁调整剂量的克罗恩病患者来说是一种可持续、有效和安全的长期治疗方法。