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首页> 外文期刊>Gut: Journal of the British Society of Gastroenterology >Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn's disease: A randomised, double-blind, placebo controlled trial (ADAFI)
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Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn's disease: A randomised, double-blind, placebo controlled trial (ADAFI)

机译：在克罗恩病的肛周瘘管闭合术中，阿达木单抗联合环丙沙星优于阿达木单抗：一项随机，双盲，安慰剂对照试验（ADAFI）

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Objective: To assess whether a combination of adalimumab and ciprofloxacin is superior to adalimumab alone in the treatment of perianal fistulising Crohn's disease (CD). Design: Randomised, double-blind, placebo controlled trial in eight Dutch hospitals. In total, 76 CD patients with active perianal fistulising disease were enrolled. After adalimumab induction therapy (160/80 mg week 0, 2), patients received 40 mg every other week together with ciprofloxacin 500 mg or placebo twice daily for 12 weeks. After 12 weeks, adalimumab was continued. Follow-up was 24 weeks. Primary endpoint (clinical response) was defined as 50% reduction of fistulas from baseline to week 12. Secondary endpoints included remission (closure of all fistulas), Perianal Crohn's Disease Activity Index, Crohn's Disease Activity Index (CDAI) and Inflammatory Bowel Disease Questionnaire (IBDQ). Results: Clinical response was observed in 71% of patients treated with adalimumab plus ciprofloxacin and in 47% treated with adalimumab plus placebo (p=0.047). Likewise, remission rate at week 12 was significantly higher (p=0.009) in the combination group (65%) compared with adalimumab plus placebo (33%). Combination treatment was associated with a higher mean CDAI change and mean IBDQ change at week 12 (p=0.005 and p=0.009, respectively). At week 24, no difference in clinical response between the two treatment groups was observed (p=0.22). No difference in safety issues was observed. Conclusions: Combination therapy of adalimumab and ciprofloxacin is more effective than adalimumab monotherapy to achieve fistula closure in CD. However, after discontinuation of antibiotic therapy, the beneficial effect of initial coadministration is not maintained. Trial registration: ClinicalTrials.gov Identifier: NCT00736983.
机译：目的：评估阿达木单抗和环丙沙星的组合是否优于单独的阿达木单抗治疗肛周瘘管克罗恩病（CD）。设计：在荷兰的八家医院进行的随机，双盲，安慰剂对照试验。总共纳入了76名患有活动性肛周瘘管疾病的CD患者。阿达木单抗诱导治疗（0、2、160 / 80 mg第2、3周）后，患者每隔一周接受40 mg联合环丙沙星500 mg或安慰剂，每天两次，共12周。 12周后，继续使用阿达木单抗。随访24周。主要终点（临床反应）定义为从基线到第12周，瘘管减少50％。次要终点包括缓解（所有瘘管关闭），肛周克罗恩病活动指数，克罗恩病活动指数（CDAI）和炎症性肠病问卷（ IBDQ）。结果：在接受阿达木单抗联合环丙沙星治疗的患者中有71％观察到临床反应，而接受阿达木单抗联合安慰剂治疗的患者有47％（p = 0.047）。同样，与阿达木单抗加安慰剂（33％）相比，组合组（65％）在第12周的缓解率显着更高（p = 0.009）。组合治疗与第12周时较高的平均CDAI变化和平均IBDQ变化相关（分别为p = 0.005和p = 0.009）。在第24周时，两个治疗组之间的临床反应均未观察到差异（p = 0.22）。在安全问题上未观察到差异。结论：阿达木单抗与环丙沙星联合治疗比阿达木单抗单药治疗CD瘘更有效。但是，停止抗生素治疗后，不能维持最初共同给药的有益效果。试验注册：ClinicalTrials.gov标识符：NCT00736983。

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