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).

OBJECTIVE: To assess whether a combination of adalimumab and superior to adalimumab alone in the treatment of perianal fistulising disease (CD). DESIGN: Randomised, double-blind, placebo controlled trial Dutch hospitals. In total, 76 CD patients with active perianal disease were enrolled. After adalimumab induction therapy (160/80 mg patients received 40 mg every other week together with ciprofloxacin 500 placebo twice daily for 12 weeks. After 12 weeks, adalimumab was Follow-up was 24 weeks. Primary endpoint (clinical response) was defined reduction of fistulas from baseline to week 12. Secondary endpoints remission (closure of all fistulas), Perianal Crohn's Disease Activity Crohn's Disease Activity Index (CDAI) and Inflammatory Bowel Disease Questionnaire (IBDQ). RESULTS: Clinical response was observed in 71% of treated with adalimumab plus ciprofloxacin and in 47% treated with plus placebo (p=0.047). Likewise, remission rate at week 12 was higher (p=0.009) in the combination group (65%) compared with adalimumab placebo (33%). Combination treatment was associated with a higher mean change and mean IBDQ change at week 12 (p=0.005 and p=0.009, week 24, no difference in clinical response between the two treatment observed (p=0.22). No difference in safety issues was observed. Combination therapy of adalimumab and ciprofloxacin is more effective 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: Identifier: NCT00736983.