Infliximab Therapy for Crohn’s Disease
Kathryn E. Wynne
Christopher J. Moran
Induction and Maintenance Infliximab Therapy for the Treatment of Moderate-to-Severe Crohn’s Disease in Children (The Reach Trial)
Hyams J, Crandall W, Kugathasan S, et al. Gastroenterology. 2007;132(3):863–873
Background
For children with Crohn’s disease (CD) who fail conventional therapy (5-aminosalicylates, immunomodulators), few treatment options were previously available. Infliximab is a monoclonal antibody against tumor necrosis factor-α (TNF-α) that became available for adults with CD in 1998 after clinical trials showed efficacy as salvage therapy.1 However, until this study, infliximab had not been rigorously studied in pediatric CD and there were concerns about tumor and infection risk.
Objectives
To assess the efficacy of induction and maintenance regimens with infliximab for pediatric CD.
Methods
Randomized, open-label study at 34 sites in North America, Europe, and Israel from 2003 to 2004.
Patients
112 children ages 6 to 17 years with moderate-to-severe CD (Pediatric Crohn’s Disease Activity Index [PCDAI] >30 at baseline) on stable immunomodulator dosing. Select exclusion criterion: prior treatment with anti–TNF-α agents.
