Jean Frédéric Colombel, William J Sandborn, Walter Reinisch, Gerassimos J Mantzaris, Asher Kornbluth, Daniel Rachmilewitz, Simon Lichtiger, Geert D'Haens, Robert H Diamond, Delma L Broussard, Kezhen L Tang, C Janneke van der Woude, Paul Rutgeerts
BACKGROUND: The comparative efficacy and safety of infliximab and azathioprine therapy alone or in combination for Crohn's disease are unknown. METHODS: In this randomized, double-blind trial, we evaluated the efficacy of infliximab monotherapy, azathioprine monotherapy, and the two drugs combined in 508 adults with moderate-to-severe Crohn's disease who had not undergone previous immunosuppressive or biologic therapy. Patients were randomly assigned to receive an intravenous infusion of 5 mg of infliximab per kilogram of body weight at weeks 0, 2, and 6 and then every 8 weeks plus daily oral placebo capsules; 2...
April 15, 2010: New England Journal of Medicine