aInflammatory Bowel Disease Unit, Policlinico S. Orsola-Malpighi, University of Bologna, Bologna bMaternal and Child Department, Ospedali Riuniti di Ancona, Ancona, Italy.
Eur J Gastroenterol Hepatol. 2014 Apr;26(4):458-65. doi: 10.1097/MEG.0000000000000045.
The anti-tumor necrosis factor (TNF) agents infliximab (IFX) and adalimumab (ADA) have been recently introduced to treat severe inflammatory bowel disease (IBD) that is unresponsive to other drugs. Several studies have confirmed the safety and efficacy of these agents for adult IBD patients, whereas there is less data on pediatric IBD. Mucosal healing, associated with fewer complications and surgeries, is considered the goal of treatment by some authors. The objective of this study was to evaluate the safety and efficacy (in terms of endoscopic, clinical, and laboratoristic response) of IFX and ADA in a cohort of pediatric patients with Crohn's disease (CD).
We conducted a retrospective analysis of prospectively collected data; we studied 33 patients (20 male, 13 female) with a diagnosis of CD established before 18 years of age: 29/33 were treated with IFX and 19/33 received ADA (four of them were naive to IFX). We evaluated clinical, endoscopic, and laboratoristic response to IFX and ADA for each patient and recorded the adverse effects of these drugs.
With regard to IFX treatment, 22.2% of patients achieved mucosal healing and 44.4% showed an endoscopic response. With regard to ADA therapy, 25% of patients achieved mucosal healing and 50% showed an endoscopic response. Overall clinical response rates for IFX and ADA were 84 and 92.3%, respectively. Both drugs were well tolerated.
To our knowledge, this is the first study reporting mucosal healing after ADA therapy in pediatric CD. We found significant mucosal healing and response rates in our group of patients. Compared with other pediatric studies, we reported similar clinical response rates and longer follow-up of patients.
肿瘤坏死因子(TNF)拮抗剂英夫利昔单抗(IFX)和阿达木单抗(ADA)最近被引入用于治疗对其他药物无反应的严重炎症性肠病(IBD)。几项研究已经证实了这些药物对成人 IBD 患者的安全性和有效性,而关于儿科 IBD 的数据较少。一些作者认为,黏膜愈合与较少的并发症和手术相关,是治疗的目标。本研究的目的是评估 IFX 和 ADA 在一组患有克罗恩病(CD)的儿科患者中的安全性和疗效(在内镜、临床和实验室反应方面)。
我们对前瞻性收集的数据进行了回顾性分析;我们研究了 33 名(20 名男性,13 名女性)在 18 岁之前确诊为 CD 的患者:29/33 名患者接受 IFX 治疗,19/33 名患者接受 ADA 治疗(其中 4 名患者对 IFX 无反应)。我们评估了每位患者对 IFX 和 ADA 的临床、内镜和实验室反应,并记录了这些药物的不良反应。
IFX 治疗组 22.2%的患者达到黏膜愈合,44.4%的患者出现内镜反应。ADA 治疗组 25%的患者达到黏膜愈合,50%的患者出现内镜反应。IFX 和 ADA 的总体临床反应率分别为 84%和 92.3%。两种药物均耐受良好。
据我们所知,这是第一项报告 ADA 治疗儿科 CD 后黏膜愈合的研究。我们发现我们组患者的黏膜愈合和反应率显著。与其他儿科研究相比,我们报告了相似的临床反应率和更长的患者随访时间。