Objectives: To assess prospectively the efficacy and safety of treatment of perianal Crohn's disease by means of a combination of surgical management and a standardized protocol for the intravenous infusion of infliximab.
Methods: A consecutive series of patients who presented with complex perianal Crohn's fistulae between November 1999 and March 2003 were included in the study. Perianal sepsis was eradicated with drainage of collections and insertion of setons. Infliximab was infused at 5 mg/kg at 0, 2, and 6 weeks. Setons were removed after the second infliximab infusion. Endpoints were defined as either complete, partial or no response as noted at subsequent outpatient follow up. Adverse reactions were recorded.
Results: Twenty-one patients had a median of three fistulae per patient (range 1-9). All patients tolerated the initial protocol, receiving a median of five infusions of infliximab (range 3-19); median follow up 20 months (range 12-52). Eleven patients (53%) were continued on maintenance therapy with 12 weekly infusions of infliximab for either a perceived clinical need for treatment or after a relapse of their symptoms. Ten (47%) patients experienced a complete response to treatment and the remaining 11 (53%) experienced a partial response. No patient failed to respond to treatment. Four adverse reactions were noted (2 mild allergies, 1 rash and 1 patient experienced joint pains). All adverse reactions settled with cessation of the drug infusion.
Conclusions: The combination of seton drainage and infusion of infliximab completely healed the perineum of 47% patients with complex fistulating perianal Crohn's disease. Partial response was seen in the remainder of patients. No serious adverse reactions reported.