Efficacy and safety of retreatment with anti-tumor necrosis factor antibody (infliximab) to maintain remission in Crohn's disease

Background & Aims: Infliximab, an anti-tumor necrosis factor monoclonal ant ibody, rapidly reduces signs and symptoms of active Crohn's disease. The ai m of this study was to determine whether repeated infusions of infliximab w ould effectively and safely maintain the remitting benefit. Methods: The ef ficacy, safety, pharmacokinetics, and immunogenicity of 4 repeated treatmen ts with 10 mg/kg infliximab given every 8 weeks were compared with the effe cts of placebo in a randomized, double-blind, placebo-controlled, parallel group trial. Seventy-three patients with active Crohn's disease who had not adequately responded to conventional therapies and then had demonstrated a clinical response (greater than or equal to 70-point decrease in the Crohn 's Disease Activity Index) to an initial infusion of infliximab (or placebo ) were studied. Results: Retreatment with infliximab maintained the clinica l benefit through the retreatment period and 8 weeks after the last infusio n in nearly all patients retreated with infliximab. Median values for Crohn 's Disease Activity Index, inflammatory bowel disease questionnaire (a qual ity of life measurement), and serum C-reactive protein concentration were m aintained at remission levels with infliximab retreatment, but not with pla cebo retreatment. Retreatment with infliximab every 8 weeks maintained seru m infliximab concentration and was well tolerated with a low incidence of i mmunogenicity. One case of lymphoma and 1 case of suspected lupus were repo rted; the complete long-term safety profile of infliximab requires addition al clinical investigation. Conclusions: Long-term treatment with infliximab showed efficacy and tolerability in managing symptoms of patients with act ive Crohn's disease not responding to conventional treatments.