Sundararajan Ramaswamy, Patel Manthankumar, Bahirwani Janak, Trivedi Chinmay, Mahmud Nadim, Khan Nabeel
Department of Gastroenterology, Corporal Michael J Crescenz VA Medical Center, Philadelphia, PA, USA.
Department of Gastroenterology, St. Luke's University Health Network, Bethlehem, PA, USA.
Crohns Colitis 360. 2024 Aug 21;6(3):otae046. doi: 10.1093/crocol/otae046. eCollection 2024 Jul.
There is limited data on the long-term clinical outcomes of bio-naïve ulcerative colitis (UC) patients who are initiated on adalimumab (ADA). Our study aims to evaluate the clinical course of a nationwide cohort of bio naïve UC patients who were started on ADA, and then followed for 5 years after initiation of the drug.
We conducted a retrospective cohort study using the US Veteran Affairs Healthcare System (VAHS). Bio naïve UC patients were followed for 5 years after initiation of ADA. The primary outcome was to determine the time to discontinuation of ADA and if patients achieved endoscopic remission by the end of follow-up.
A total of 387 patients were included among whom 193 (49.87%) had pancolitis. The highest rate of ADA discontinuation was within the first year, with the elderly having a higher rate of discontinuation (HR 1.67, 95% CI: 1.14-2.45) and those on concomitant immunomodulators having a lower rate of discontinuation (HR 0.70, 95% CI: 0.48-1.03). In total, 125 (32.30%) patients remained on ADA at the end of their maximum follow-up. 54 (43.90%) achieved endoscopic remission.
Among bio-naive UC patients who were started on ADA, a third were still on the drug at the end of 5 years and half had endoscopic remission. The rate of discontinuation was highest within the first year of initiation, but patients continued to stop the drug over the course of follow-up.
关于初治生物制剂的溃疡性结肠炎（UC）患者使用阿达木单抗（ADA）的长期临床结局的数据有限。我们的研究旨在评估全国范围内初治生物制剂的UC患者开始使用ADA后的临床病程，并在药物开始使用后随访5年。
我们使用美国退伍军人事务医疗系统（VAHS）进行了一项回顾性队列研究。初治生物制剂的UC患者在开始使用ADA后随访5年。主要结局是确定停用ADA的时间以及患者在随访结束时是否实现内镜缓解。
共纳入387例患者，其中193例（49.87%）患有全结肠炎。ADA停药率最高的是在第一年，老年人的停药率更高（风险比[HR] 1.67，95%置信区间[CI]：1.14 - 2.45），而同时使用免疫调节剂的患者停药率较低（HR 0.70，95% CI：0.48 - 1.03）。在最长随访结束时，共有125例（32.30%）患者仍在使用ADA。54例（43.90%）实现了内镜缓解。
在开始使用ADA的初治生物制剂的UC患者中，三分之一在5年末仍在使用该药物，一半实现了内镜缓解。停药率在开始使用的第一年内最高，但在随访过程中患者仍持续停药。
