Dr Talbot and colleagues assessed prospectively the efficacy and safety of treatment of perianal Crohn's disease by a combination of surgical management and a standardized protocol for the intravenous infusion of infliximab.
The researchers included a consecutive series of patients who presented with complex perianal Crohn's fistulae between November 1999 and March 2003.
Perianal sepsis was eradicated with drainage of collections and insertion of setons.
|Adverse reactions were settled by cessation of the drug infusion|
The investigators infused infliximab at 5 mg/kg at 0, 2, and 6 weeks and setons were removed after the second infliximab infusion.
The researchers defined the study endpoints as either complete, partial or no response as noted at subsequent outpatient follow up with recordings of adverse reactions.
The research team reported that 21 patients had a median of 3 fistulae per patient (range 19).
The team also found that all patients tolerated the initial protocol, receiving a median of 5 infusions of infliximab (range 319) and median follow up of 20 months (range 1,252).
The investigators continued 11 patients(53%)on maintenance therapy with 12 weekly infusions of infliximab for either a perceived clinical need for treatment or after a relapse of their symptoms.
10 (47%) patients experienced a complete response to treatment and the remaining 11 (53%) experienced a partial response with no patient failing to respond to treatment.
4 adverse reactions were noted including 2 mild allergies, 1 rash and 1 patient experienced joint pains, which the researchers settled by cessation of the drug infusion.
Dr Talbot concludes, “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 and no serious adverse reactions reported.”