April 16, 2013
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Adalimumab/ciprofloxacin effective for Crohn’s disease-related perianal fistula closure

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Patients with Crohn’s disease-related perianal fistulas experienced better outcomes with adalimumab and ciprofloxacin combination therapy than with adalimumab alone in a recent study.

In a double blind, multicenter trial in the Netherlands, researchers evaluated 76 adults with Crohn’s disease (CD) and perianal fistulizing disease treated with adalimumab once every 2 weeks along with either placebo (n=39) or 500 mg ciprofloxacin (CIP, n=37) twice daily for 12 weeks. Adalimumab was continued until completion of follow-up at 24 weeks. Dosing for adalimumab began at 160 mg, was reduced to 80 mg at 2 weeks and then to 40 mg for the remainder of the study. All participants were evaluated according to the Perianal Disease Activity Index (PDAI), Crohn’s Disease Activity Index (CDAI) and IBD Questionnaire (IBDQ) at baseline and at 12 and 24 weeks.

Patients achieved clinical response (50% or greater reduction of draining fistulas at week 12) in 71% of cases in the CIP group, compared with 47% in the placebo group (P=.047). More CIP recipients achieved remission at week 12 (65% vs. 33%; P=.009).

Median PDAI scores decreased significantly from baseline in both groups (P<.001) at 12 weeks, but the difference was not statistically significant. CDAI score decreased significantly more among CIP recipients at 12 and 24 weeks (P=.005 for both), and mean IBDQ score decreased more among CIP recipients at 12 (P=.009) but not 24 weeks.

Upon completion of follow-up, clinical response was similar (62% of CIP and 47% of placebo recipients) and complete response also occurred at similar rates (53% vs. 33%; P=.098).

The two treatments did not differ significantly with regard to the frequency or severity of adverse events (P=.6). Infection was the most commonly experienced event, with others including fatigue, headache and nausea.

“This is the first trial demonstrating a superior effect of combination therapy of adalimumab with ciprofloxacin compared with adalimumab monotherapy to achieve fistula closure in CD-related perianal fistulizing disease,” the researchers wrote. “However, after discontinuation of antibiotic therapy, the beneficial effect of initial co-administration is not maintained.”