Department of Gastroenterology, Hospital Universitari Germans Trias i Pujol, Carretera del Canyet s/n, Badalona, Catalonia 08916 Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; Hospital Clínic de Barcelona, Barcelona, Spain.
Dig Liver Dis. 2023 Jan;55(1):46-52. doi: 10.1016/j.dld.2022.07.013. Epub 2022 Aug 7.
Anti-TNF agents are the only effective biological agents for the prevention of postoperative recurrence (POR) in Crohn's disease (CD). However, they are contraindicated or have been shown to fail in some patients. Although ustekinumab and vedolizumab were licensed for CD some years ago, data in this setting are scarce.
All CD patients in whom ustekinumab or vedolizumab was prescribed for the prevention of POR within three months of ileocolonic resection with anastomosis were identified from the ENEIDA registry. The development of endoscopic, clinical and surgical POR was registered.
Forty patients were treated for the prevention of POR with ustekinumab and 25 were treated with vedolizumab. Eighty per cent had at least one risk factor for POR (prior resections, active smoking, perianal disease or penetrating disease behaviour). All the patients had been exposed to anti-TNF therapy. After a median follow-up of 17 and 26 months, the cumulative probability of clinical POR at 12 months after surgery was 32% and 30% for ustekinumab and vedolizumab, respectively. Endoscopic assessment within the first 18 months after surgery was available for 80% of the patients on ustekinumab and 70% for those on vedolizumab. The rate of endoscopic POR was 42% for ustekinumab and 40% for vedolizumab. One patient treated with ustekinumab and two with vedolizumab underwent a new intestinal resection.
Ustekinumab and vedolizumab seem to be effective in the prevention of POR in patients at high risk. Our results warrant controlled trials comparing these drugs with conventional therapies.
抗 TNF 制剂是预防克罗恩病（CD）术后复发（POR）的唯一有效生物制剂。然而，在某些患者中，它们被禁忌或已被证明无效。虽然乌司奴单抗和维得利珠单抗在数年前已被批准用于 CD，但在此背景下的数据仍然有限。
从 ENEIDA 登记处中确定了所有在接受回肠结肠吻合术 3 个月内因 POR 而接受乌司奴单抗或维得利珠单抗预防治疗的 CD 患者。记录内镜、临床和手术 POR 的发生情况。
40 例患者接受乌司奴单抗预防 POR，25 例患者接受维得利珠单抗预防 POR。80%的患者至少存在 1 个 POR 风险因素（既往手术、主动吸烟、肛周疾病或穿透性疾病行为）。所有患者均曾接受过抗 TNF 治疗。术后中位随访 17 个月和 26 个月时，乌司奴单抗和维得利珠单抗组术后 12 个月的临床 POR 累积发生率分别为 32%和 30%。80%的乌司奴单抗组和 70%的维得利珠单抗组在术后前 18 个月内可进行内镜评估。乌司奴单抗组和维得利珠单抗组的内镜 POR 发生率分别为 42%和 40%。1 例乌司奴单抗治疗患者和 2 例维得利珠单抗治疗患者接受了新的肠道切除术。
乌司奴单抗和维得利珠单抗似乎可有效预防高危患者的 POR。我们的结果支持开展比较这些药物与常规治疗的对照试验。
