Radboud University Medical Centre, Nijmegen.
Franciscus Gasthuis & Vlietland, Rotterdam.
Eur J Gastroenterol Hepatol. 2023 Mar 1;35(3):261-269. doi: 10.1097/MEG.0000000000002506. Epub 2022 Dec 22.
Real-world data showed that ustekinumab is an effective treatment for Crohn's disease for up to 52 weeks. Yet, long-term effectiveness and safety outcomes beyond 52 weeks are limited. This study aimed to evaluate the corticosteroid-free clinical remission for up to 104 weeks. Secondary aims were focused on biochemical disease, dosing adjustments and safety outcomes.
This multicentre prospective cohort study enrolled Crohn's disease patients who started ustekinumab between May 2016 and September 2019. Participants had scheduled outpatient visits at week 0, 13, 26, 52 and 104. Data on clinical disease [Harvey Bradshaw Index (HBI) = 4 points = remission], biochemical disease (faecal calprotectin = 200 µg/g or C-reactive protein = 10 mg/l = remission), dose adjustments and adverse drug reactions (ADRs) were recorded.
We included 101 Crohn's disease patients. In all patients, the proportion of patients in corticosteroid-free clinical remission was 35 and 36% at week 52 and 104. Of patients achieving corticosteroid-free remission at week 52, more than half maintained corticosteroid-free remission throughout week 104. Biochemical remission rates were 25 and 30% at week 52 and 104, respectively. In the first year of treatment, 33% required their first dose escalation, and 15% in the second year. Overall, 7% of patients discontinued ustekinumab due to ADRs. Ustekinumab persistency rates were 68% at week 52 and 59% at week 104.
Ustekinumab is an effective and well-tolerated treatment for Crohn's disease. More than half of all patients continued ustekinumab treatment after 104 weeks whereas one-third achieved corticosteroid-free remission.
真实世界数据表明，乌司奴单抗治疗克罗恩病长达 52 周是有效的。然而，52 周后长期有效性和安全性结果有限。本研究旨在评估 104 周内无皮质类固醇的临床缓解率。次要目标集中在生化疾病、剂量调整和安全性结果上。
这是一项多中心前瞻性队列研究，纳入了 2016 年 5 月至 2019 年 9 月期间开始接受乌司奴单抗治疗的克罗恩病患者。参与者在第 0、13、26、52 和 104 周进行门诊随访。记录临床疾病[哈维-布拉德肖指数（HBI）=4 分=缓解]、生化疾病（粪便钙卫蛋白=200μg/g 或 C 反应蛋白=10mg/l=缓解）、剂量调整和药物不良反应（ADR）的数据。
我们纳入了 101 例克罗恩病患者。在所有患者中，无皮质类固醇的临床缓解比例分别为第 52 周时的 35%和 36%，第 104 周时的 35%和 36%。在第 52 周达到无皮质类固醇缓解的患者中，超过一半的患者在第 104 周时仍保持无皮质类固醇缓解。生化缓解率分别为第 52 周时的 25%和第 104 周时的 30%。在第一年治疗中，33%的患者需要首次剂量升级，第二年中有 15%的患者需要首次剂量升级。总体而言，有 7%的患者因 ADR 而停用乌司奴单抗。乌司奴单抗的持久性率分别为第 52 周时的 68%和第 104 周时的 59%。
乌司奴单抗是治疗克罗恩病的一种有效且耐受性良好的治疗方法。超过一半的患者在 104 周后继续接受乌司奴单抗治疗，其中三分之一的患者达到无皮质类固醇缓解。
