Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab.
OBJECTIVE
The efficacy of infliximab for treating patients with ulcerative colitis has been established.


METHODS
The Active Ulcerative Colitis Trial (ACT)-1 and ACT-2 randomized, double-blind, placebo-controlled studies evaluated infliximab induction and maintenance therapy in moderately to severely active ulcerative colitis. Overall, 728 patients received placebo or infliximab (5 or 10 mg/kg) intravenously at weeks 0, 2, and 6, then every 8 weeks through week 46 (ACT-1) or 22 (ACT-2). Colectomy, hospitalization, and surgery/procedure data through 54 weeks after the first infusion were obtained from ACT-1, ACT-2, and associated data sources. In the prespecified analysis, all data were combined to ascertain time to colectomy. Kaplan-Meier product-limit method was used to estimate the cumulative incidence of colectomy, and log-rank test was used to compare the combined infliximab group and placebo.


RESULTS
Eighty-seven percent (630 of 728) of patients had complete colectomy follow-up; 13% (98 of 728) of patients had a median follow-up of 6.2 months. The cumulative incidence of colectomy through 54 weeks was 10% for infliximab and 17% for placebo (P = .02), yielding an absolute risk reduction of 7%. Compared with placebo, fewer ulcerative colitis-related hospitalizations and surgeries/procedures per 100 patient-years of treatment occurred with infliximab therapy: 40 vs 20 (P = .003) and 34 vs 21 (P = .03), respectively. Serious adverse events occurring in infliximab-treated patients included serious infections, tuberculosis, histoplasmosis, listeriosis, and malignancy.


CONCLUSIONS
Patients with moderately to severely active ulcerative colitis treated with infliximab were less likely to undergo colectomy through 54 weeks than those receiving placebo.
Sandborn
William J
WJ
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA. sandborn.william@mayo.edu
Rutgeerts
Paul
P
Feagan
Brian G
BG
Reinisch
Walter
W
Olson
Allan
A
Johanns
Jewel
J
Lu
Jiandong
J
Horgan
Kevin
K
Rachmilewitz
Daniel
D
Hanauer
Stephen B
SB
Lichtenstein
Gary R
GR
de Villiers
Willem J S
WJ
Present
Daniel
D
Sands
Bruce E
BE
Colombel
Jean Frédéric
JF
D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003082:Colectomy / Q000706:statistics & numerical data*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000601:surgery*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005060:Europe; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006760:Hospitalization; D006801:Humans; D000069285:Infliximab; D007275:Injections, Intravenous; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009656:North America; D016016:Proportional Hazards Models; D018570:Risk Assessment; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab