Department of Gastroenterology, St Marks Hospital, London, UK.
Imperial College Health Partners, London, UK.
Expert Opin Biol Ther. 2023 Jul-Dec;23(12):1317-1329. doi: 10.1080/14712598.2023.2279650. Epub 2023 Dec 28.
Data on the optimum positioning of biologics in the treatment of inflammatory bowel disease (IBD) are limited.
This was a longitudinal retrospective study of linked health-care data from northwest London, UK, for adults who started ustekinumab for IBD from 1 April 20161 April 2016 to 1 April 20211 April 2021. We compared outcomes by line of therapy (1 vs. 2 or 3+) and age group (18‒59 years or ≥ 60 years). In an analysis of CD patients, we calculated risks of IBD-related hospitalization, IBD-related abdominal surgery, ustekinumab persistence, and switching by line of therapy.
Of 163 patients screened, 149 were eligible. Age had no effect on outcomes. Elective all-cause hospital admissions were significantly higher when ustekinumab was used as second-line or third-line therapy compared with first-line treatment ( = 0.0048 and = 0.001, respectively). In CD patients the numbers of hospital admissions were also higher with second-line or third-line therapy ( = 0.040 and = 0.018, respectively). Use of ustekinumab as third-line therapy significantly increased the risk of IBD-related hospitalization (hazard ratio 2.5, 95% CI 1.1‒5.6, = 0.029), IBD-related abdominal surgery (9.45, 1.2‒75.7, = 0.03), and switching (14.6, 1.6‒131.0, = 0.02). Drug persistence risks did not differ.
These findings support the use of ustekinumab as first-line therapy.
关于生物制剂治疗炎症性肠病（IBD）的最佳定位数据有限。
这是一项对英国伦敦西北部的医疗保健数据进行的纵向回顾性研究，研究对象为 2016 年 4 月 1 日至 2021 年 4 月 1 日期间开始使用乌司奴单抗治疗 IBD 的成年人。我们按治疗线（1 线与 2 线或 3 线+）和年龄组（18-59 岁或≥60 岁）比较了结局。在对 CD 患者的分析中，我们计算了不同治疗线的 IBD 相关住院、IBD 相关腹部手术、乌司奴单抗持续治疗和转换的风险。
在筛选的 163 名患者中，有 149 名符合条件。年龄对结局没有影响。与一线治疗相比，乌司奴单抗作为二线或三线治疗时，择期全因住院的风险显著更高（=0.0048 和=0.001）。在 CD 患者中，二线或三线治疗的住院人数也更高（=0.040 和=0.018）。三线治疗中使用乌司奴单抗显著增加了 IBD 相关住院的风险（风险比 2.5，95%CI 1.1-5.6，=0.029）、IBD 相关腹部手术（9.45，1.2-75.7，=0.03）和转换（14.6，1.6-131.0，=0.02）。药物持续治疗风险没有差异。
这些发现支持将乌司奴单抗作为一线治疗。
