Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab.

Abstract

BACKGROUND & AIMS:

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.

• Authors: William J Sandborn, Paul Rutgeerts, Brian G Feagan, Walter Reinisch, Allan Olson, Jewel Johanns, Jiandong Lu, Kevin Horgan, Daniel Rachmilewitz, Stephen B Hanauer, Gary R Lichtenstein, Willem J S de Villiers, Daniel Present, Bruce E Sands, Jean Frédéric Colombel
• Journal: Gastroenterology (Gastroenterology) Vol. 137 Issue 4 Pg. 1250-60; quiz 1520 (Oct 2009) ISSN: 1528-0012 [Electronic] United States
• PMID: 19596014 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents
• Antibodies, Monoclonal
• Gastrointestinal Agents
• Infliximab

Topics

• Adult
• Anti-Inflammatory Agents (administration & dosage, adverse effects, therapeutic use)
• Antibodies, Monoclonal (administration & dosage, adverse effects, therapeutic use)
• Colectomy (statistics & numerical data)
• Colitis, Ulcerative (drug therapy, surgery)
• Double-Blind Method
• Drug Administration Schedule
• Europe
• Female
• Gastrointestinal Agents (administration & dosage, adverse effects, therapeutic use)
• Hospitalization
• Humans
• Infliximab
• Injections, Intravenous
• Kaplan-Meier Estimate
• Male
• Middle Aged
• North America
• Proportional Hazards Models
• Risk Assessment
• Severity of Illness Index
• Time Factors
• Treatment Outcome