Infliximab maintenance treatment reduces hospitalizations, surgeries, and procedures in fistulizing Crohn's disease.
OBJECTIVE
Infliximab is effective in closing fistulas in patients with Crohn's disease. We examined the effect of infliximab maintenance treatment on hospitalizations, surgeries, and procedures in patients with fistulizing Crohn's disease enrolled in the ACCENT II study.


METHODS
After 5 mg/kg infliximab at weeks 0, 2, and 6, a total of 282 patients were separately randomized at week 14 as responders (at least a 50% reduction from baseline in the number of draining fistulas at both weeks 10 and 14) or nonresponders to receive placebo or 5 mg/kg infliximab maintenance every 8 weeks. At week 22 and later, patients who lost response could be treated with a maintenance dose 5 mg/kg higher. Data on Crohn's disease-related hospitalizations, surgeries, and procedures were compared between the treatment groups for responders and all randomized patients.


RESULTS
A total of 282 patients were randomized at week 14, of whom 195 were randomized as responders. Among patients randomized as responders, those who received infliximab maintenance had significantly fewer mean hospitalization days (0.5 vs. 2.5 days; P < .05), mean numbers (per 100 patients) of hospitalizations (11 vs. 31; P < .05), all surgeries and procedures (65 vs. 126; P < .05), inpatient surgeries and procedures (7 vs. 41; P < .01), and major surgeries (2 vs. 11; P < .05), compared with those who received placebo maintenance.


CONCLUSIONS
In patients with fistulizing Crohn's disease, infliximab 5 mg/kg every 8 weeks significantly reduced hospitalizations, surgeries, and procedures compared with placebo.
Lichtenstein
Gary R
GR
Division of Gastroenterology, Hospital of the University of Pennsylvania, Philadelphia, PA 19104, USA. grl@uphs.upenn.edu
Yan
Songkai
S
Bala
Mohan
M
Blank
Marion
M
Sands
Bruce E
BE
D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D003424:Crohn Disease / Q000150:complications*; D013505:Digestive System Surgical Procedures / Q000706:statistics & numerical data*; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D000069285:Infliximab; D007412:Intestinal Fistula / Q000188:drug therapy / Q000209:etiology* / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged
D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab