Tokita Kazuhide, Shimizu Hirotaka, Takeuchi Ichiro, Shimizu Toshiaki, Arai Katsuhiro
Center for Pediatric Inflammatory Bowel Disease, Division of Gastroenterology, National Center for Child Health and Development, Tokyo, Japan.
Department of Pediatrics and Adolescent Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Pediatr Gastroenterol Hepatol Nutr. 2022 Nov;25(6):461-472. doi: 10.5223/pghn.2022.25.6.461. Epub 2022 Nov 2.
Golimumab (GLM) is an anti-tumor necrosis factor (TNF)-α antibody preparation known to be less immunogenic than infliximab (IFX) or adalimumab. Few reports on GLM in pediatric patients with ulcerative colitis (UC) are available. This study aimed to review the long-term durability and safety of GLM in a pediatric center.
The medical records of 17 pediatric patients (eight boys and nine girls) who received GLM at the National Center for Child Health and Development were retrospectively reviewed.
The median age at GLM initiation was 13.9 (interquartile range 12.0-16.3) years. Fourteen patients had pancolitis, and 11 had severe disease (pediatric ulcerative colitis activity index ≥65). Ten patients were biologic-naïve, and 50% achieved corticosteroid-free remission at week 54. Two patients discontinued prior anti-TNF-α agents because of adverse events during remission. Both showed responses to GLM without unfavorable events through week 54. However, the efficacy of GLM in patients who showed primary nonresponse or loss of response to IFX was limited. Four of the five patients showed non-response at week 54. Patients with severe disease had significantly lower corticosteroid-free remission rate at week 54 than those without severe disease. No severe adverse events were observed during the study period.
GLM appears to be safe and useful for pediatric patients with UC. Patients with mild to moderate disease who responded to but had some adverse events with prior biologics may be good candidates for GLM. Its safety and low immunogenicity profile serve as favorable options for selected children with UC.
戈利木单抗（GLM）是一种抗肿瘤坏死因子（TNF）-α抗体制剂，已知其免疫原性低于英夫利昔单抗（IFX）或阿达木单抗。关于GLM用于儿童溃疡性结肠炎（UC）患者的报道较少。本研究旨在回顾GLM在一家儿科中心的长期疗效和安全性。
回顾性分析了在国立儿童健康与发展中心接受GLM治疗的17例儿科患者（8例男孩和9例女孩）的病历。
开始使用GLM时的中位年龄为13.9岁（四分位间距12.0 - 16.3岁）。14例患者患有全结肠炎，11例患有重度疾病（儿童溃疡性结肠炎活动指数≥65）。10例患者未使用过生物制剂，50%的患者在第54周实现了无糖皮质激素缓解。2例患者因缓解期出现不良事件而停用先前的抗TNF-α药物。这2例患者在第54周对GLM均有反应且无不良事件。然而，GLM对IFX原发无反应或反应丧失的患者疗效有限。5例患者中有4例在第54周无反应。重度疾病患者在第54周的无糖皮质激素缓解率显著低于非重度疾病患者。研究期间未观察到严重不良事件。
GLM似乎对儿童UC患者安全且有效。对先前生物制剂有反应但出现一些不良事件的轻至中度疾病患者可能是GLM的良好候选者。其安全性和低免疫原性特征是部分UC患儿的有利选择。
