英夫利昔单抗单药治疗与联合治疗对中度至重度克罗恩病患儿临床缓解维持情况的比较
Monotherapy with infliximab versus combination therapy in the maintenance of clinical remission in children with moderate to severe Crohn disease.
作者信息
Kierkuś Jarosław, Iwańczak Barbara, Wegner Agnieszka, Dadalski Maciej, Grzybowska-Chlebowczyk Urszula, Łazowska Izabella, Maślana Jolanta, Toporowska-Kowalska Ewa, Czaja-Bulsa Grażyna, Mierzwa Grażyna, Korczowski Bartosz, Czkwianianc Elżbieta, Żabka Alicja, Szymańska Edyta, Krzesiek Elżbieta, Więcek Sabina, Sładek Małgorzata
机构信息
*Children's Memorial Health Institute, Warsaw †Department of Pediatrics, Gastroenterology and Nutrition, Medical University of Wroclaw ‡Department of Paediatrics, Medical University of Silesia, Gastroenterology Unit, Upper-Silesian Child Health Care Centre, Katowice §Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw ||Wl. Buszkowski Kielce Province Children's Hospital, Kielce ¶Department of Paediatric Allergology, Gastroenterology and Nutrition, Medical University of Lodz #Paediatric Nursery Unit of Pomeranian Medical University, Division of Paediatrics, Gastroenterology and Rheumatology of Zdroje Hospital in Szczecin **Department of Pediatrics, Allergology and Gastroenterology, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun ††Department of Pediatrics, Gastroenterology and Nutrition Jagiellonian University School of Medicine, Cracow, Poland.
出版信息
J Pediatr Gastroenterol Nutr. 2015 May;60(5):580-5. doi: 10.1097/MPG.0000000000000684.
OBJECTIVES
The aim of the present study was to compare the efficacy and safety of 2 protocols of maintenance therapy with infliximab (IFX) and an immunomodulatory agent in pediatric patients with Crohn disease (CD): withdrawal of immunomodulators versus continuation of immunosuppressants.
METHODS
The present multicenter randomized open-label trial included 99 patients with CD (ages 14.5 ± 2.6 years) who were administered IFX (5 mg/kg body weight) along with an immunomodulatory agent (azathioprine 1.5-3 mg/kg body weight per day, methotrexate 10-25 mg/week). After 10 weeks of the induction therapy, 84 responders were centrally randomized into 1 of the following groups: group I (n = 45) in which IFX and an immunomodulatory agent were continued up to week 54 and group II (n = 39) in which the immunomodulatory agent was discontinued after 26 weeks.
RESULTS
The induction therapy was reflected by a significant decrease in Pediatric Crohn's Disease Activity Index (PCDAI) and Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) values. After the maintenance phase, the analyzed groups did not differ significantly in terms of the clinical response loss rates and final PCDAI and SES-CD scores. Furthermore, no significant intragroup differences were documented between mean PCDAI scores determined at the end of induction and maintenance phases. Intensification/modification of the treatment was required in 13 of 45 (29%) and 11 of 39 (28%) patients of groups I and II, respectively. A total of 9 serious adverse events were documented; none of the patients died during the trial.
CONCLUSIONS
Twenty-six weeks likely represent the safe duration of combined IFX/immunomodulatory therapy in our sample of pediatric patients with CD.
目的
本研究旨在比较两种英夫利昔单抗（IFX）与免疫调节剂维持治疗方案在克罗恩病（CD）儿科患者中的疗效和安全性：停用免疫调节剂与继续使用免疫抑制剂。
方法
本多中心随机开放标签试验纳入了99例CD患者（年龄14.5±2.6岁），给予IFX（5mg/kg体重）联合免疫调节剂（硫唑嘌呤1.5 - 3mg/kg体重/天，甲氨蝶呤10 - 25mg/周）。诱导治疗10周后，84例缓解者被集中随机分为以下组：第一组（n = 45），IFX和免疫调节剂持续使用至第54周；第二组（n = 39），免疫调节剂在26周后停用。
结果
诱导治疗表现为儿童克罗恩病活动指数（PCDAI）和简化克罗恩病内镜活动评分（SES - CD）值显著降低。维持阶段后，分析的两组在临床缓解丢失率以及最终PCDAI和SES - CD评分方面无显著差异。此外，诱导期和维持期末测定的平均PCDAI评分在组内也无显著差异。第一组45例患者中有13例（29%）、第二组39例患者中有11例（28%）需要强化/调整治疗。共记录到9例严重不良事件；试验期间无患者死亡。
结论
在我们的CD儿科患者样本中，26周可能是IFX/免疫调节剂联合治疗的安全持续时间。
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