TY - JOUR
T1 - Infliximab Maintenance Therapy for Fistulizing Crohn's Disease
AU - Sands, Bruce E.
AU - Anderson, Frank H.
AU - Bernstein, Charles N.
AU - Chey, William Y.
AU - Feagan, Brian G.
AU - Fedorak, Richard N.
AU - Kamm, Michael A.
AU - Korzenik, Joshua R.
AU - Lashner, Bret A.
AU - Onken, Jane E.
AU - Rachmilewitz, Daniel
AU - Rutgeerts, Paul
AU - Wild, Gary
AU - Wolf, Douglas C.
AU - Marsters, Paul A.
AU - Travers, Suzanne B.
AU - Blank, Marion A.
AU - Van Deventer, Sander J.
PY - 2004/2/26
Y1 - 2004/2/26
N2 - BACKGROUND: Infliximab, a monoclonal antibody against tumor necrosis factor, is an effective maintenance therapy for patients with Crohn's disease without fistulas. It is not known whether infliximab is an effective maintenance therapy for patients with fistulas. METHODS: We performed a multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy of infliximab maintenance therapy in 306 adult patients with Crohn's disease and one or more draining abdominal or perianal fistulas of at least three months' duration. Patients received 5 mg of infliximab per kilogram of body weight intravenously on weeks 0, 2, and 6. A total of 195 patients who had a response at weeks 10 and 14 and 87 patients who had no response were then randomly assigned to receive placebo or 5 mg of infliximab per kilogram every eight weeks and to be followed to week 54. The primary analysis was the time to the loss of response among patients who had a response at week 14 and underwent randomization. RESULTS: The time to loss of response was significantly longer for patients who received infliximab maintenance therapy than for those who received placebo maintenance (more than 40 weeks vs. 14 weeks, P<0.001). At week 54, 19 percent of patients in the placebo maintenance group had a complete absence of draining fistulas, as compared with 36 percent of patients in the infliximab maintenance group (P=0.009). CONCLUSIONS: Patients with fistulizing Crohn's disease who have a response to induction therapy with infliximab have an increased likelihood of a sustained response over a 54-week period if infliximab treatment is continued every 8 weeks.
AB - BACKGROUND: Infliximab, a monoclonal antibody against tumor necrosis factor, is an effective maintenance therapy for patients with Crohn's disease without fistulas. It is not known whether infliximab is an effective maintenance therapy for patients with fistulas. METHODS: We performed a multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy of infliximab maintenance therapy in 306 adult patients with Crohn's disease and one or more draining abdominal or perianal fistulas of at least three months' duration. Patients received 5 mg of infliximab per kilogram of body weight intravenously on weeks 0, 2, and 6. A total of 195 patients who had a response at weeks 10 and 14 and 87 patients who had no response were then randomly assigned to receive placebo or 5 mg of infliximab per kilogram every eight weeks and to be followed to week 54. The primary analysis was the time to the loss of response among patients who had a response at week 14 and underwent randomization. RESULTS: The time to loss of response was significantly longer for patients who received infliximab maintenance therapy than for those who received placebo maintenance (more than 40 weeks vs. 14 weeks, P<0.001). At week 54, 19 percent of patients in the placebo maintenance group had a complete absence of draining fistulas, as compared with 36 percent of patients in the infliximab maintenance group (P=0.009). CONCLUSIONS: Patients with fistulizing Crohn's disease who have a response to induction therapy with infliximab have an increased likelihood of a sustained response over a 54-week period if infliximab treatment is continued every 8 weeks.
UR - http://www.scopus.com/inward/record.url?scp=10744221312&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa030815
DO - 10.1056/NEJMoa030815
M3 - Article
C2 - 14985485
AN - SCOPUS:10744221312
SN - 0028-4793
VL - 350
SP - 876
EP - 885
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 9
ER -