Shimizu Hirotaka, Arai Katsuhiro, Takeuchi Ichiro, Minowa Kei, Hosoi Kenji, Sato Masamichi, Oka Itsuhiro, Kaburaki Yoichiro, Shimizu Toshiaki
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. 2021 Jan;24(1):7-18. doi: 10.5223/pghn.2021.24.1.7. Epub 2021 Jan 8.
The long-term efficacy and safety of infliximab (IFX) in children with ulcerative colitis (UC) have not been well-evaluated. Here, we reviewed the long-term durability and safety of IFX in our single center pediatric cohort with UC.
This retrospective study included 20 children with UC who were administered IFX.
For induction, 5 mg/kg IFX was administered at weeks 0, 2, and 6, followed by every 8 weeks for maintenance. The dose and interval of IFX were adjusted depending on clinical decisions. Corticosteroid (CS)-free remission without dose escalation (DE) occurred in 30% and 25% of patients at weeks 30 and 54, respectively. Patients who achieved CS-free remission without DE at week 30 sustained long-term IFX treatment without colectomy. However, one-third of the patients discontinued IFX treatment because of a primary nonresponse, and one-third experienced secondary loss of response (sLOR). IFX durability was higher in patients administered IFX plus azathioprine for >6 months. Four of five patients with very early onset UC had a primary nonresponse. Infusion reactions (IRs) occurred in 10 patients, resulting in discontinuation of IFX in four of these patients. No severe opportunistic infections occurred, except in one patient who developed acute focal bacterial nephritis. Three patients developed psoriasis-like lesions.
IFX is relatively safe and effective for children with UC. Clinical remission at week 30 was associated with long-term durability of colectomy-free IFX treatment. However, approximately two-thirds of the patients were unable to continue IFX therapy because of primary nonresponse, sLOR, IRs, and other side effects.
英夫利昔单抗（IFX）治疗溃疡性结肠炎（UC）患儿的长期疗效和安全性尚未得到充分评估。在此，我们回顾了IFX在我们单中心儿科UC队列中的长期疗效和安全性。
这项回顾性研究纳入了20例接受IFX治疗的UC患儿。
诱导治疗时，在第0、2和6周给予5mg/kg的IFX，随后每8周给药一次进行维持治疗。IFX的剂量和间隔根据临床决策进行调整。分别有30%和25%的患者在第30周和第54周实现了无剂量递增（DE）的无皮质类固醇（CS）缓解。在第30周实现无DE的无CS缓解的患者持续接受长期IFX治疗且未行结肠切除术。然而，三分之一的患者因原发性无反应而停止IFX治疗，三分之一的患者出现继发性反应丧失（sLOR）。接受IFX联合硫唑嘌呤治疗>6个月的患者IFX的持久性更高。五例极早发型UC患者中有四例出现原发性无反应。10例患者发生输液反应（IRs），其中4例因此停止使用IFX。除1例发生急性局灶性细菌性肾炎的患者外，未发生严重的机会性感染。3例患者出现银屑病样病变。
IFX对UC患儿相对安全有效。第30周的临床缓解与无结肠切除术的IFX治疗的长期疗效相关。然而，约三分之二的患者因原发性无反应、sLOR、IRs和其他副作用而无法继续IFX治疗。
