Use Ciprofloxacin with Adalimumab for Perianal Crohn Disease

At least half of draining fistulas closed in 71% of patients randomized to combination therapy versus 47% with anti-TNF therapy alone.

Antibiotics, such as metronidazole and ciprofloxacin, and anti–tumor necrosis factor (anti-TNF) agents are effective in treatment of perianal fistulas in Crohn disease. Although patients are often treated with both, the efficacy of this combination therapy is uncertain.

In the current controlled trial from eight hospitals in the Netherlands, 76 patients (mean age, 36) with Crohn disease–related, active perianal fistulas were randomized to receive adalimumab loading doses, followed by 40 mg every other week for 24 weeks, plus either 500 mg of ciprofloxacin or placebo twice daily for 12 weeks. The primary endpoint was closure of 50% of draining fistulas.

Thirty-four percent of patients had been treated previously with infliximab. The mean number of draining fistulas at baseline was 1.57. At the end of 12 weeks, the percentage of patients who achieved the primary endpoint was 71% in the ciprofloxacin group versus 47% in the placebo group (P=0.047). At week 24 (12 weeks after discontinuation of ciprofloxacin), some patients in the ciprofloxacin group had lost their response, and the difference in primary endpoint between the ciprofloxacin and placebo groups was no longer significant (62% vs. 47%).

CITATION(S):

Dewint P et al. 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). Gut 2013 Mar 23; [e-pub ahead of print].