Rapid fistula healing may predispose Crohn's disease patients to abscess development.
Dr Sands and colleagues from the USA analyzed data from ACCENT II.
The research team determined whether fistula-related abscess development is affected by infliximab exposure.
Infliximab 5 mg/kg infusions were given at weeks 0, 2 and 6.
Patients were evaluated for fistula response for 2 consecutive visits at least 4 weeks apart.
In the trial, 282 patients were randomized at week 14 to either placebo or infliximab 5 mg/kg every 8 weeks through week 46.
|15% with infliximab developed at least 1 fistula-related abscess vs 19% with placebo|
|Alimentary Pharmacology & Therapeutics|
The team reported that if response was lost at or after week 22, patients could crossover to a 5 mg/kg higher infliximab dose.
Fistula-related abscesses were diagnosed by physical examination or by imaging procedures according to usual practice.
The researchers found that infliximab exposure was approximately 2-fold higher for the infliximab maintenance group.
The team noted that 15% of patients in the infliximab maintenance group had at least 1 newly developed fistula-related abscess.
In the placebo maintenance group, 19% had at least 1 newly developed fistula-related abscess.
The research team observed that the proportion of patients with a new fistula-related abscess was similar.
The team noted the similar incidence regardless of whether or not patients crossed over to a 5 mg/kg higher infliximab dose.
The number of fistula-related abscesses diagnosed over time did not differ between groups.
Dr Sands' team concluded, “Abscess development in patients with fistulizing Crohn's disease is not dependent on cumulative infliximab exposure.”