De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease

BACKGROUND/RATIONALE:
Treatment outcomes of patients with inflammatory bowel disease (IBD) have improved enormously during the past decade due to the use of anti-tumour necrosis factor (anti-TNF) therapy. As a result, 67 to 91% of paediatric patients and 66% of adult patients is still in sustained remission two years after the initiation of anti-TNF therapy. Prolonged use of anti-TNFs comes with disadvantages such as dose dependent susceptibility to infections and dermatological adverse effects. Preliminary, mostly uncontrolled studies suggest that dose reduction by dosing interval lengthening is a realistic option in a relevant proportion of patients with IBD, provided that intensive follow-up is applied.
OBJECTIVE:
To evaluate whether a faecal calprotectin (FC) guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD, compared with an unchanged dosing interval.

背景与研究依据：
近十年来，随着抗肿瘤坏死因子（anti-tumour necrosis factor, anti-TNF）疗法的应用，炎症性肠病（inflammatory bowel disease, IBD）患者的治疗结局得到了显著改善。因此，在启动anti-TNF疗法两年后，67%至91%的儿科患者以及66%的成年患者仍可维持持续缓解状态。但长期使用anti-TNF类药物存在诸多弊端，例如剂量依赖性感染易感性与皮肤不良反应。现有初步且多为非对照的研究表明，若实施强化随访，通过延长给药间隔以减少给药剂量，在相当比例的IBD患者中是可行的方案。
研究目的：
本研究旨在评估，与维持原给药间隔方案相比，以粪便钙卫蛋白（faecal calprotectin, FC）为指导的延长anti-TNF给药间隔策略，在维持IBD患者缓解状态方面是否具有非劣效性。