Gebeyehu Gerum Gashaw, Broglio Giacomo, Liu Eleanor, Limdi Jimmy K, Selinger Christian, Fiske Joseph, Razanskaite Violeta, Smith Philip J, Flanagan Paul K, Subramanian Sreedhar
Department Gastroenterology, Liverpool University Hospital NHS Foundation Trust, Liverpool, United Kingdom.
Department of Internal Medicine, IRCCS San Matteo of Pavia, University of Pavia, Pavia, Italy.
Inflamm Bowel Dis. 2025 May 12;31(5):1325-1333. doi: 10.1093/ibd/izae174.
Biologic therapies are associated with increased infection risk among elderly patients with inflammatory bowel disease (IBD). However, there are few data on the safety and effectiveness of ustekinumab compared with anti-tumor necrosis factor (anti-TNF) agents in the elderly.
The study sought to compare the safety and effectiveness of ustekinumab and anti-TNF agents in elderly Crohn's disease (CD) patients. Patients ≥60 years of age who commenced ustekinumab or an anti-TNF agent for CD were included in this retrospective multicenter cohort. The primary outcome was incidence of serious infections requiring hospitalization. Effectiveness was assessed by clinical remission, clinical response, and treatment persistence rates at 6 months. We adjusted for confounders using inverse probability of treatment weighting (IPTW) and performed a logistic regression analysis to assess factors associated with serious infections, clinical remission, and treatment persistence.
Eighty-three patients commencing ustekinumab and 124 commencing anti-TNF therapy were included. There was no difference in serious infection rates between anti-TNF agents (2.8%) and ustekinumab (3.1%) (P = .924) after propensity adjustment. Clinical remission rates were comparable at 6 months for ustekinumab (55.9%) and anti-TNF agents (52.4%) (P = .762). There was a significant reduction in HBI at 6 months in both groups. Treatment persistence was comparable between ustekinumab (90.6%) and anti-TNF agents (90.0%) at 6 months. Cox regression analysis did not show differences in treatment persistence (hazard ratio, 1.23; 95% confidence interval, 0.57-2.61; P = .594) and serious infection incidence (hazard ratio, 1.38; 95% confidence interval, 0.25-7.57; P = .709) by 6 months.
We observed comparable safety and effectiveness for ustekinumab and anti-TNF agents in treating elderly CD patients.
生物疗法与老年炎症性肠病（IBD）患者感染风险增加相关。然而，与抗肿瘤坏死因子（抗TNF）药物相比，关于乌司奴单抗在老年人中的安全性和有效性的数据较少。
该研究旨在比较乌司奴单抗和抗TNF药物在老年克罗恩病（CD）患者中的安全性和有效性。本回顾性多中心队列纳入了年龄≥60岁且开始使用乌司奴单抗或抗TNF药物治疗CD的患者。主要结局是需要住院治疗的严重感染发生率。通过6个月时的临床缓解、临床反应和治疗持续率评估有效性。我们使用治疗权重的逆概率（IPTW）对混杂因素进行调整，并进行逻辑回归分析以评估与严重感染、临床缓解和治疗持续相关的因素。
纳入了83例开始使用乌司奴单抗的患者和124例开始抗TNF治疗的患者。倾向调整后，抗TNF药物（2.8%）和乌司奴单抗（3.1%）的严重感染率无差异（P = 0.924）。乌司奴单抗（55.9%）和抗TNF药物（52.4%）在6个月时的临床缓解率相当（P = 0.762）。两组在6个月时血红蛋白指数（HBI）均显著降低。乌司奴单抗（90.6%）和抗TNF药物（90.0%）在6个月时的治疗持续率相当。Cox回归分析未显示6个月时治疗持续率（风险比，1.23；95%置信区间，0.57 - 2.61；P = 0.594）和严重感染发生率（风险比，1.38；95%置信区间，0.25 - 7.57；P = 0.709）存在差异。
我们观察到乌司奴单抗和抗TNF药物在治疗老年CD患者方面具有相当的安全性和有效性。
