Clinical and endosonographic effect of ciprofloxacin on the treatment of perianal fistulae in Crohn's disease with infliximab: a double‐blind placebo‐controlled study

• Published in: Alimentary pharmacology & therapeutics Vol. 20; no. 11‐12; pp. 1329 - 1336
• Main Authors: West, R. L., Woude, C. J., Hansen, B. E., Felt‐Bersma, R. J. F., Tilburg, A. J. P., Drapers, J. A. G., Kuipers, E. J.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Science Ltd 01-12-2004
• Subjects: Adolescent; Adult; Anti-Infective Agents - administration & dosage; Antibodies, Monoclonal - administration & dosage; Ciprofloxacin - administration & dosage; Crohn Disease - diagnostic imaging; Crohn Disease - drug therapy; Double-Blind Method; Drug Therapy, Combination; Endosonography - methods; Female; Follow-Up Studies; Gastrointestinal Agents - administration & dosage; Humans; Infliximab; Male; Middle Aged; Rectal Fistula - diagnostic imaging; Rectal Fistula - drug therapy; Treatment Outcome
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/j.1365-2036.2004.02247.x

Summary
Background : Ciprofloxacin is effective in perianal Crohn's disease but after treatment discontinuation symptoms reoccur. Infliximab is effective but requires maintenance therapy.
Aim : To evaluate the effect of combined ciprofloxacin and infliximab in perianal Crohn's disease.
Methods : A double‐blind placebo‐controlled study was conducted. Patients were randomly assigned to receive 500‐mg ciprofloxacin twice daily or a placebo for 12 weeks. All patients received 5‐mg/kg infliximab in week 6, 8 and 12 and were followed for 18 weeks. Primary end‐point was clinical response, defined as a 50% or greater reduction from baseline in the number of draining fistulae. Secondary end‐points were the change in Perianal Disease Activity Index and hydrogen peroxide enhanced three‐dimensional endoanal ultrasonography findings. Analysis was by intention‐to‐treat.
Results : Twenty‐four patients were included but two discontinued treatment. At week 18, response was 73% (eight of 11) in the ciprofloxacin group and 39% (five of 13) in the placebo group (P = 0.12). Using logistic regression analysis patients treated with ciprofloxacin tended to respond better (OR = 2.37, CI: 0.94–5.98, P = 0.07). The Perianal Disease Activity Index score only improved (P = 0.008) in the ciprofloxacin group. Three‐dimensional endoanal ultrasonography improved in three patients with a clinical response.
Conclusions : A combination of ciprofloxacin and infliximab tended to be more effective than infliximab alone.