Maintenance infliximab does not result in increased abscess development in fistulizing Crohn's disease: results from the ACCENT II study.
BACKGROUND
Rapid fistula healing may predispose Crohn's disease patients to abscess development.


OBJECTIVE
Data from ACCENT II were analysed to determine whether fistula-related abscess development is affected by infliximab exposure.


METHODS
Following infliximab 5 mg/kg infusions at weeks 0, 2 and 6, patients were evaluated for fistula response for two consecutive visits at least 4 weeks apart. Patients (N = 282) were randomized at week 14 to either placebo or infliximab 5 mg/kg every 8 weeks through week 46. 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.


RESULTS
Infliximab exposure was approximately twofold higher for the infliximab maintenance group. Twenty-one (15%) patients in the infliximab maintenance group had at least one newly developed fistula-related abscess compared with 27 (19%) in the placebo maintenance group (P = 0.526). The proportion of patients with a new fistula-related abscess was similar 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.


CONCLUSIONS
Abscess development in patients with fistulizing Crohn's disease is not dependent on cumulative infliximab exposure.
Sands
B E
BE
MGH Crohn's and Colitis Center and Gastrointestinal Unit, Massachusetts General Hospital, Boston, MA 02114, USA. bsands@partners.org
Blank
M A
MA
Diamond
R H
RH
Barrett
J P
JP
Van Deventer
S J
SJ
D000038:Abscess / Q000139:chemically induced*; D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use; D016009:Chi-Square Distribution; D003424:Crohn Disease / Q000150:complications / Q000188:drug therapy*; D018592:Cross-Over Studies; D003627:Data Interpretation, Statistical; D004334:Drug Administration Schedule; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D000069285:Infliximab; D007262:Infusions, Intravenous; D007410:Intestinal Diseases / Q000139:chemically induced; D007412:Intestinal Fistula / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D013997:Time Factors; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab