TY - JOUR
T1 - Colectomy Rate Comparison After Treatment of Ulcerative Colitis With Placebo or Infliximab
AU - Sandborn, William J.
AU - Rutgeerts, Paul
AU - Feagan, Brian G.
AU - Reinisch, Walter
AU - Olson, Allan
AU - Johanns, Jewel
AU - Lu, Jiandong
AU - Horgan, Kevin
AU - Rachmilewitz, Daniel
AU - Hanauer, Stephen B.
AU - Lichtenstein, Gary R.
AU - de Villiers, Willem J.S.
AU - Present, Daniel
AU - Sands, Bruce E.
AU - Colombel, Jean Frédéric
PY - 2009/10
Y1 - 2009/10
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=70349418632&partnerID=8YFLogxK
U2 - 10.1053/j.gastro.2009.06.061
DO - 10.1053/j.gastro.2009.06.061
M3 - Article
C2 - 19596014
AN - SCOPUS:70349418632
SN - 0016-5085
VL - 137
SP - 1250
EP - 1260
JO - Gastroenterology
JF - Gastroenterology
IS - 4
ER -