Merrick Victoria M, Mortier Kajal, Williams Linda J, Muhammed Rafeeq, Auth Marcus K H, Elawad Mamoun, Fell John M E, Beattie R Mark, Loganathan Sabarinathan, Torrente Franco, Morris Mary-Anne, Charlton Charles, Croft Nick M, Rodrigues Astor, Furman Mark, Vadamalayan Babu, Jenkins Huw, Zamvar Veena, Mitton Sally G, Chong Sonny, Cosgrove Mike, Akobeng Anthony, Wilson David C, Russell Richard K
Child Life and Health, University of Edinburgh, Edinburgh.
UK IBD Audit, Royal College of Physicians, Regent's Park, London.
J Pediatr Gastroenterol Nutr. 2018 Feb;66(2):274-280. doi: 10.1097/MPG.0000000000001679.
The aim of this study was to measure the effectiveness, safety, and use of anti-tumor necrosis Factor (TNF) therapy in pediatric inflammatory bowel disease in the United Kingdom (UK).
Prospective UK audit of patients newly starting anti-TNF therapy. Disease severity was assessed using Physician Global Assessment +/or the Paediatric Crohn Disease Activity Index.
A total of 37 centers participated (23/25 specialist pediatric inflammatory bowel disease sites). A total of 524 patients were included: 429 with Crohn disease (CD), 76 with ulcerative colitis (UC), and 19 with IBD unclassified (IBDU). Eighty-seven percent (488/562) of anti-TNF was infliximab; commonest indication was active luminal CD 77% (330/429) or chronic refractory UC/IBDU 56% (53/95); 79% (445/562) had concomitant co-immunosuppression. In CD (267/429 male), median time from diagnosis to treatment was 1.42 years (interquartile range 0.63-2.97). Disease (at initiation) was moderate or severe in 91% (156/171) by Physician Global Assessment compared to 41% (88/217) by Paediatric Crohn Disease Activity Index (Kappa (κ) 0.28 = only "fair agreement"; P < 0.001.Where documented, 77% (53/69) of patients with CD responded to induction; and 65% (46/71) entered remission. A total of 2287 infusions and 301.96 years of patient' follow-up (n = 385) are represented; adverse events affected 3% (49/1587) infliximab and 2% (2/98) adalimumab infusions (no deaths or malignancies). Peri-anal abscess drainage was less common after anti-TNF initiation (CD), that is 26% (27/102) before, 7% (3/42) after (P = 0.01); however, pre and post anti-TNF data collection was not over equal time periods.
Anti-TNFs are effective treatments, usually given with thiopurine co-immunosuppression. This study highlights deficiencies in formal documentation of effect and disparity between disease severity scoring tools, which need to be addressed to improve ongoing patient care.
本研究旨在评估抗肿瘤坏死因子（TNF）疗法在英国儿童炎症性肠病治疗中的有效性、安全性及应用情况。
对英国新开始接受抗TNF治疗的患者进行前瞻性审计。采用医生整体评估和/或儿童克罗恩病活动指数评估疾病严重程度。
共有37个中心参与（25个儿童炎症性肠病专科中心中的23个）。共纳入524例患者：429例克罗恩病（CD）患者，76例溃疡性结肠炎（UC）患者，19例未分类炎症性肠病（IBDU）患者。87%（488/562）的抗TNF药物为英夫利昔单抗；最常见的适应证为活动性肠腔型CD 77%（330/429）或慢性难治性UC/IBDU 56%（53/95）；79%（445/562）的患者同时接受了免疫抑制治疗。在CD患者中（267/429为男性），从诊断到治疗的中位时间为1.42年（四分位间距0.63 - 2.97年）。根据医生整体评估，91%（156/171）的患者疾病（开始治疗时）为中度或重度，而根据儿童克罗恩病活动指数评估为41%（88/217）（卡方值（κ）0.28 = 仅为“中等一致性”；P < 0.001）。有记录显示，77%（53/69）的CD患者诱导治疗有反应；65%（46/71）进入缓解期。共记录了2287次输注和301.96年的患者随访（n = 385）；不良事件影响了3%（49/1587）的英夫利昔单抗输注和2%（2/98）的阿达木单抗输注（无死亡或恶性肿瘤病例）。抗TNF治疗开始后肛周脓肿引流较少见（CD患者），即治疗前为26%（27/102），治疗后为7%（3/42）（P = 0.01）；然而，抗TNF治疗前后的数据收集时间并不相等。
抗TNF药物是有效的治疗方法，通常与硫嘌呤类免疫抑制药物联合使用。本研究突出了疗效正式记录方面的不足以及疾病严重程度评分工具之间的差异，需要加以解决以改善对患者的持续护理。
