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

摘要: Background & Aims: Infliximab, an anti‐tumor necrosis factor monoclonal antibody, rapidly reduces signs and symptoms of active Crohn’s disease. The aim this study was to determine whether repeated infusions infliximab would effectively safely maintain the remitting benefit. Methods: efficacy, safety, pharmacokinetics, immunogenicity 4 treatments with 10 mg/kg given every 8 weeks were compared effects placebo in a randomized, double-blind, placebocontrolled, parallel group trial. Seventy-three patients disease who had not adequately responded conventional therapies then demonstrated clinical response ($70-point decrease Disease Activity Index) initial infusion (or placebo) studied. Results: Retreatment maintained benefit through retreatment period after last nearly all retreated infliximab. Median values for Index, inflammatory bowel questionnaire (a quality life measurement), serum C-reactive protein concentration at remission levels retreatment, but retreatment.