Department of Pediatrics, School of Medicine, Kyungpook National University, Daegu, Korea.
Crohn's and Colitis Association in Daegu-Gyeongbuk [CCAiD], Daegu, Korea.
J Crohns Colitis. 2018 May 25;12(6):644-652. doi: 10.1093/ecco-jcc/jjy021.
We aimed to investigate the outcome in paediatric-onset Crohn's disease patients who had discontinued infliximab after maintaining clinical remission with combined immunosuppression, and to determine factors associated with clinical relapse.
We conducted a retrospective observational study of 63 paediatric-onset Crohn's disease patients who had stopped scheduled infliximab during sustained corticosteroid-free clinical remission for at least 1 year with infliximab and azathioprine, and were followed up for at least 1 year thereafter. Cumulative relapse rates and the median time to relapse were estimated statistically. Factors at cessation were also evaluated for their association with clinical relapse.
After a median follow-up period of 4.3 years [range, 1-7.5 years], 60.3% [38/63] of patients had experienced clinical relapse. According to Kaplan-Meier survival analysis, the estimated cumulative relapse rates at 1, 4, and 6 years were 19.0%, 62.2%, and 75.2%, respectively, and the median relapse time was 3.3 years from infliximab cessation. According to multivariate Cox proportional hazard regression analysis, infliximab trough levels of ≥2.5 μg/mL and incomplete mucosal healing were associated with clinical relapse (hazard ratio [HR] = 7.199, 95% confidence interval [CI] = 1.641-31.571, p = 0.009 and HR = 3.628, 95% CI = 1.608-8.185, p = 0.002, respectively). Although re-treatment with infliximab was effective in 90.9% [30/33] of patients, 7.9% [3/38] eventually underwent surgery within 1 year of relapse.
Considering the high cumulative relapse rates in the long term and cases of severe relapse requiring surgery, discontinuing infliximab in paediatric-onset Crohn's disease patients is currently inadvisable. However, there may be a subgroup of patients who are good candidates for infliximab withdrawal.
我们旨在研究在联合免疫抑制下维持临床缓解后停用英夫利昔单抗的儿科克罗恩病患者的结局，并确定与临床复发相关的因素。
我们对 63 例儿科克罗恩病患者进行了回顾性观察性研究，这些患者在停用英夫利昔单抗和硫唑嘌呤后至少 1 年达到无皮质类固醇的临床缓解，并至少随访 1 年。通过统计学方法估计累积复发率和中位复发时间。还评估了停药时的因素与临床复发的关系。
在中位随访 4.3 年（范围，1-7.5 年）后，60.3%（38/63）的患者出现临床复发。根据 Kaplan-Meier 生存分析，1、4 和 6 年的累积复发率估计分别为 19.0%、62.2%和 75.2%，从停用英夫利昔单抗到复发的中位时间为 3.3 年。根据多变量 Cox 比例风险回归分析，英夫利昔单抗谷浓度≥2.5μg/ml 和不完全黏膜愈合与临床复发相关（风险比[HR] = 7.199，95%置信区间[CI] = 1.641-31.571，p = 0.009 和 HR = 3.628，95%CI = 1.608-8.185，p = 0.002）。尽管再用英夫利昔单抗治疗在 90.9%（30/33）的患者中有效，但 7.9%（3/38）的患者在复发后 1 年内最终接受了手术。
考虑到长期内累积复发率较高，以及需要手术治疗的严重复发病例，目前不建议在儿科克罗恩病患者中停用英夫利昔单抗。然而，可能有一部分患者适合停用英夫利昔单抗。
