Gastroenterology, Digestive Endoscopy and Nutrition Unit, Institute for Maternal and Child Health, IRCCS, 'Burlo Garofolo', Trieste, Italy.
Pediatric Gastroenterology and Endoscopy Unit, Institute 'Giannina Gaslini', Genoa, Italy.
United European Gastroenterol J. 2019 Jul;7(6):759-766. doi: 10.1177/2050640619847592. Epub 2019 Apr 25.
Very few data regarding the use of infliximab in children with very early-onset inflammatory bowel disease (VEO-IBD) have been reported.
We aimed to assess the efficacy and the safety of infliximab in children with VEO-IBD compared with older children.
Children treated with infliximab were identified within the Italian IBD registry. The primary outcome was the rate of clinical remission at weeks 14 and 54. Secondary outcomes included the proportion of partial clinical response, treatment duration, and incidence of adverse events.
Forty-two children with VEO-IBD were compared with 130 children with IBD. Despite significantly higher infliximab withdrawals in VEO-IBD patients during induction (42.9% vs 7.7% < 0.01), remission rates at week 14 were similar (28.6% vs 43.8%, = 0.10). At week 54 fewer VEO-IBD children were in remission (15.8% vs 54.3%, < 0.01). The treatment duration was shorter in VEO-IBD (median 12.0 vs 18.4 months, < 0.01). During the induction phase, adverse events were more common in the VEO-IBD group ( < 0.01).
Compared with older children, VEO-IBD patients have higher rates of infliximab failures, lower remission rates at one year, and more often experience adverse events during induction.
很少有关于英夫利昔单抗在非常早发性炎症性肠病（VEO-IBD）患儿中应用的数据报道。
我们旨在评估与年长儿童相比，英夫利昔单抗在 VEO-IBD 患儿中的疗效和安全性。
在意大利 IBD 登记处中确定接受英夫利昔单抗治疗的患儿。主要结局为治疗 14 周和 54 周时的临床缓解率。次要结局包括部分临床缓解率、治疗持续时间和不良反应发生率。
将 42 例 VEO-IBD 患儿与 130 例 IBD 患儿进行比较。尽管在诱导期 VEO-IBD 患儿中英夫利昔单抗停药率显著更高（42.9%比 7.7%， < 0.01），但 14 周时的缓解率相似（28.6%比 43.8%， = 0.10）。54 周时，更少的 VEO-IBD 患儿达到缓解（15.8%比 54.3%， < 0.01）。VEO-IBD 患儿的治疗持续时间更短（中位数 12.0 比 18.4 个月， < 0.01）。在诱导期，VEO-IBD 组的不良反应更常见（ < 0.01）。
与年长儿童相比，VEO-IBD 患儿英夫利昔单抗失败率更高，一年时缓解率更低，且在诱导期更常发生不良反应。
