Tsumura Naoya, Kato Ken, Yasuda Ryosuke, Yoshioka Shinichiro, Takedatsu Hidetoshi, Mizuochi Tatsuki
Department of Pediatrics and Child Health, Kurume University School of Medicine, Kurume, Japan.
Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan.
Pediatr Gastroenterol Hepatol Nutr. 2025 May;28(3):166-175. doi: 10.5223/pghn.2025.28.3.166. Epub 2025 May 8.
The long-term efficacy and safety of infliximab (IFX) in Japanese children with inflammatory bowel disease (IBD) remain unclear. This study aimed to examine the long-term outcomes of IFX treatment in Japanese children with IBD.
We retrospectively recruited patients aged <16 years who were diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) at Kurume University Hospital in Japan between 2011 and 2022 and examined the effectiveness and safety of IFX. We characterized the responses to IFX as primary response, primary nonresponse (PNR), secondary loss of response (sLOR), or still receiving IFX.
Among the 77 enrolled patients with UC (median age, 10 years) and 48 with CD (median age, 12 years), 55 (27 with UC and 28 with CD) received IFX treatment. IFX treatment was significantly more common in patients with CD (58.3%) than in those with UC (35.1%; =0.016). The PNR was significantly greater in patients with UC (18.5%) than in those with CD (0.0%; =0.023), as was the sLOR (UC, 51.9%; CD, 21.4%; =0.026). The likelihood of continuing IFX treatment during follow-up (median, 38 months) was significantly higher in patients with CD (71.4%) than in those with UC (29.6%; =0.003). Adverse events resulting in the discontinuation of IFX occurred in 3.6% of the patients; one patient with CD developed leukemia, and the other had a serious infusion reaction.
The long-term durability of IFX in Japanese pediatric patients with IBD was inadequate in UC compared with CD. Serious adverse events in 3.6% of patients required discontinuation.
英夫利昔单抗（IFX）在日本炎症性肠病（IBD）儿童中的长期疗效和安全性尚不清楚。本研究旨在探讨IFX治疗日本IBD儿童的长期疗效。
我们回顾性招募了2011年至2022年期间在日本久留米大学医院诊断为溃疡性结肠炎（UC）或克罗恩病（CD）的16岁以下患者，并研究了IFX的有效性和安全性。我们将对IFX的反应分为初始反应、初始无反应（PNR）、继发反应丧失（sLOR）或仍在接受IFX治疗。
在77例登记的UC患者（中位年龄10岁）和48例CD患者（中位年龄12岁）中，55例（27例UC和28例CD）接受了IFX治疗。IFX治疗在CD患者（58.3%）中比在UC患者（35.1%）中显著更常见（P=0.016）。UC患者的PNR（18.5%）显著高于CD患者（0.0%；P=0.023），sLOR也是如此（UC为51.9%，CD为21.4%；P=0.026）。在随访期间（中位时间38个月）继续接受IFX治疗的可能性在CD患者（71.4%）中显著高于UC患者（29.6%；P=0.003）。导致停用IFX的不良事件发生在3.6%的患者中；1例CD患者发生白血病，另1例发生严重输液反应。
与CD相比，IFX在日本IBD儿科患者中的长期持久性在UC中不足。3.6%的患者出现严重不良事件需要停药。
