Background One in three children with Crohn’s disease develop perianal fistula complications (PFCs), among the most disturbing and difficult-to-treat disease-related complications. Retrospective evidence suggests PFCs may be preventable. Objective We aimed to determine if early antitumour necrosis factor-alpha (anti-TNF⍺) therapy prevents PFC development in a well-characterised prospective cohort of paediatric patients with Crohn’s disease who were free from PFC at enrolment. Design RISK was a multicentre inception cohort of children newly diagnosed with Crohn’s disease. We included all patients who had never experienced PFCs 30 days after study enrolment. We conducted nearest-neighbour propensity score-matched triad analyses. Matching was performed to balance patient characteristics across three mutually exclusive treatment groups based on therapy prior to either PFC development or the end of the observation period. Results Among 873 patients without perianal fistula, 447 matched patients were included (149 per treatment group). The presence of non-penetrating perianal lesions (large skin tags, ulcers and/or fissures) was significantly associated with PFC development, with 4-fold greater odds of PFC (OR 4.08, 95% CI (95% CI) 1.70 to 9.78; p=0.0016). Early anti-TNF⍺ therapy was associated with an 82% decrease in the odds of PFC (OR 0.18, 95% CI 0.05 to 0.66; p=0.01). Among those with perianal lesions, anti-TNF⍺ therapy was associated with 94% reduced odds of PFC development (OR 0.055, 95% CI 0.006 to 0.50; p=0.010). No other treatment group was associated with reduced risk of PFC. Conclusion Early anti-TNF therapy prevents perianal fistula development, especially among patients at increased risk. Data may be obtained from a third party and are not publicly available. The results of this study are based on data obtained from the IBD Plexus program of the Crohn’s & Colitis Foundation ().

中文翻译：

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早期肿瘤坏死因子拮抗剂治疗可预防克罗恩病患儿肛周瘘管的发展：RISK 研究的事后分析


背景 三分之一的克罗恩病患儿会出现肛周瘘并发症 （PFC），这是最令人不安和难以治疗的疾病相关并发症之一。回顾性证据表明 PFC 可能是可以预防的。目的 我们旨在确定早期抗肿瘤坏死因子-α （抗 TNF⍺） 治疗是否能阻止 PFC 的明确特征前瞻性队列中发生 PFC，这些患者在入组时没有 PFC。设计 RISK 是一个多中心初始队列，针对新诊断患有克罗恩病的儿童。我们纳入了所有在研究入组后 30 天从未经历过 PFC 的患者。我们进行了最近邻倾向得分匹配的三联征分析。根据 PFC 发展前或观察期结束前的治疗，进行匹配以平衡三个互斥治疗组中的患者特征。结果 在 873 例无肛周瘘的患者中，共纳入 447 例匹配的患者 （每个治疗组 149 例）。非穿透性肛周病变（大皮赘、溃疡和/或裂缝）的存在与 PFC 的发生显著相关，PFC 的几率高出 4 倍（OR 4.08,95% CI （95% CI） 1.70 至 9.78;p=0.0016）。早期抗 TNF⍺ 治疗与 PFC 几率降低 82% 相关 （OR 0.18,95% CI 0.05 至 0.66;p = 0.01）。在有肛周病变的患者中，抗 TNF⍺ 治疗与 PFC 发生几率降低 94% 相关 （OR 0.055,95% CI 0.006 至 0.50;p = 0.010）。没有其他治疗组与 PFC 风险降低相关。结论 早期抗 TNF 治疗可预防肛周瘘管的发生，尤其是在风险增加的患者中。数据可能从第三方获得，并且不会公开。 这项研究的结果基于从克罗恩病和结肠炎基金会的IBD丛项目获得的数据（）。