Kang Ben, Choi So Yoon, Kim Hye Seung, Kim Kyunga, Lee Yoo Min, Choe Yon Ho
Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Biostatistics and Clinical Epidemiology Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Korea.
J Crohns Colitis. 2016 Nov;10(11):1279-1286. doi: 10.1093/ecco-jcc/jjw086. Epub 2016 Apr 19.
We aimed to compare the efficacy of combined immunosuppression in terms of mucosal healing in paediatric patients with moderate-to-severe luminal Crohn's disease receiving infliximab according to either an 'escalated combined immunosuppression' or an 'early combined immunosuppression' strategy.
In this prospective observational study, the efficacy of combined immunosuppression was evaluated in terms of mucosal healing at weeks 14 and 54 from baseline infliximab infusion. Comparison was performed between the escalated combined immunosuppression group [group A] and the early combined immunosuppression group [group B]. Factors associated with mucosal healing at weeks 14 and 54 from baseline infliximab infusion were also investigated.
Seventy-six patients initiated infliximab with concomitant azathioprine [group A = 28; group B = 48]. Comparison of baseline characteristics revealed a significantly longer duration from initial diagnosis to infliximab infusion in group A [median 8.1 vs. 0.7 months; p < 0.001]. Mucosal healing was achieved in 32% of patients in group A and 51% in group B at week 14 [p = 0.121], and in 42% in group A and 74% in group B at week 54 [p = 0.007]. Group B was also positively associated with mucosal healing at week 54 on multivariate logistic regression [odds ratio = 6.216, 95% confidence interval = 1.782-21.686, p = 0.004].
Mucosal healing during combined immunosuppression is more effectively achieved by treatment with an early combined immunosuppression strategy without corticosteroid induction administered within 1 month rather than escalating to receive combination therapy later during the course. The therapeutic window of opportunity in early Crohn's disease may be shorter than generally thought, especially in children.
我们旨在比较按照“逐步联合免疫抑制”或“早期联合免疫抑制”策略,接受英夫利昔单抗治疗的中重度管腔型克罗恩病儿科患者在黏膜愈合方面联合免疫抑制的疗效。
在这项前瞻性观察研究中,从英夫利昔单抗输注基线起第14周和第54周时,根据黏膜愈合情况评估联合免疫抑制的疗效。对逐步联合免疫抑制组(A组)和早期联合免疫抑制组(B组)进行比较。还研究了从英夫利昔单抗输注基线起第14周和第54周时与黏膜愈合相关的因素。
76例患者开始使用英夫利昔单抗并同时使用硫唑嘌呤(A组 = 28例;B组 = 48例)。基线特征比较显示,A组从初始诊断到英夫利昔单抗输注的持续时间显著更长(中位数8.1个月对0.7个月;p < 0.001)。第14周时,A组32%的患者实现黏膜愈合,B组为51%(p = 0.121);第54周时,A组为42%,B组为74%(p = 0.007)。多因素逻辑回归分析显示,B组在第54周时也与黏膜愈合呈正相关(比值比 = 6.216,95%置信区间 = 1.782 - 21.686,p = 0.004)。
联合免疫抑制期间,通过早期联合免疫抑制策略(1个月内不使用糖皮质激素诱导)而非在病程后期逐步升级接受联合治疗,能更有效地实现黏膜愈合。早期克罗恩病的治疗机会窗可能比一般认为的更短,尤其是在儿童中。