Latras-Cortés I, Sáez Hortelano J C, Suárez-Álvarez P, Cano-Sanz N, Ortega-Valin L, Sierra-Ausín M
Department of Gastroenterology-IBD Unit, University Hospital of León, C/ Altos de Nava, S/N. 24008, León, Spain.
Department of Pharmacology, University Hospital of León, León, Spain.
Dig Dis Sci. 2025 Mar 19. doi: 10.1007/s10620-025-08978-0.
Anti-TNF treatment failure in Crohn's disease is common, and the literature on the selection of subsequent treatment is scant. Ustekinumab may be associated with high persistence rates and it appears to be effective in perianal disease.
Primary objective: persistence, clinical, and biologic remission with ustekinumab.
Persistence of the first biologic therapy, reasons for change of treatment, need for dose optimization, surgery, hospitalizations, and adverse events with ustekinumab.
Retrospective, observational, single-center study from a prospective database of Crohn's disease adult patients receiving ustekinumab after failure of anti-TNF or vedolizumab. A sub-analysis was performed to evaluate ustekinumab persistence after the approval of risankizumab and upadacitinib.
Mean duration with ustekinumab was 27.65 months (SD 18.27) and persistence was 86.76%. Clinical remission was 40.63% at week 4, 54.35% at week 8, 54.9% at year 1, 76.92% at year 4, and 100% at year 5. Persistence with ustekinumab was longer than with anti-TNF: year 1, 93.2 vs 72.06%; year 2, 89.4 vs 45.59%; and year 3, 86.1 vs 30.88%. Just over one-third (36.76%) of patients required dose optimization. Nine (13.24%) patients stopped treatment due to primary non-response [1 (1.47%)], loss of response [5(7.35%)], and adverse events [3 (4.41%)]. Eleven (16.18%) patients needed surgery and hospitalization. After the approval of upadacitinib and risankizumab, ustekinumab persistence was 80.88%. Seven (70%) of the patients with perianal disease achieved clinical remission and 4 (40%) completed fistula healing.
Ustekinumab may have better persistence as a second-line treatment compared to anti-TNF and may be effective in perianal disease.
克罗恩病患者抗TNF治疗失败很常见，而关于后续治疗选择的文献较少。乌司奴单抗可能具有较高的持续治疗率，且似乎对肛周疾病有效。
主要目标：乌司奴单抗的持续治疗率、临床及生物学缓解情况。
首次生物治疗的持续时间、治疗改变的原因、剂量优化的必要性、手术情况、住院情况以及乌司奴单抗的不良事件。
对一个前瞻性数据库进行回顾性、观察性、单中心研究，该数据库纳入了抗TNF或维多珠单抗治疗失败后接受乌司奴单抗治疗的成年克罗恩病患者。在瑞莎珠单抗和乌帕替尼获批后进行了一项亚分析，以评估乌司奴单抗的持续治疗率。
使用乌司奴单抗的平均持续时间为27.65个月（标准差18.27），持续治疗率为86.76%。第4周时临床缓解率为40.63%，第8周时为54.35%，第1年时为54.9%，第4年时为76.92%，第5年时为100%。乌司奴单抗的持续治疗时间长于抗TNF治疗：第1年，分别为93.2%和72.06%；第2年，分别为89.4%和45.59%；第3年，分别为86.1%和30.88%。略超过三分之一（36.76%）的患者需要进行剂量优化。9名（13.24%）患者因原发性无反应[1名（1.47%）]、反应丧失[5名（7.35%）]和不良事件[3名（4.41%）]而停止治疗。11名（16.18%）患者需要手术和住院治疗。在乌帕替尼和瑞莎珠单抗获批后，乌司奴单抗的持续治疗率为80.88%。7名（70%）肛周疾病患者实现了临床缓解，4名（40%）患者瘘管愈合。
与抗TNF治疗相比，乌司奴单抗作为二线治疗可能具有更好的持续治疗率，且可能对肛周疾病有效。
