Concomitant therapy with methotrexate and anti-TNF-α in pediatric patients with refractory crohn's colitis: a case series.

BACKGROUND: Crohn's colitis refractory to anti-tumor necrosis factor alpha (TNF-α) therapy is commonly seen in tertiary care centers for pediatric inflammatory bowel disease (IBD). We report our experience in managing pediatric refractory Crohn's colitis with concomitant use of methotrexate and anti-TNF-α therapy.

METHODS: We reviewed records from 2007 to 2010 at the Mayo Clinic pediatric IBD center. We included all patients with Crohn's disease (CD) failing anti-TNF-α therapy who then received concomitant methotrexate. The primary endpoint was clinical remission, defined as inactive disease in accordance with the short pediatric CD activity index (PCDAI). The secondary endpoint was last day of follow-up.

RESULTS: Fourteen patients with CD received concomitant methotrexate and anti-TNF-α treatment (age, mean [range], 15.7 [6-20] years; standard deviation [SD], 3.4 years). Mean age at diagnosis was 12.5 years (range, 3-17 years; SD, 3.83 years). The male-to-female ratio was 10:4. All patients had moderate to severe disease activity using the short PCDAI and had predominately Crohn's colitis. Twelve patients were previously treated with thiopurines (85.7%). Seven patients (50%) were in clinical remission within an average of 6 weeks postmethotrexate induction. Five patients (35.7%) experienced adverse events including nausea and headache, yet only one discontinued therapy due to adverse events. Infection with Clostridium difficile was common, complicating therapy in four patients (28.6%).

CONCLUSIONS: Concomitant use of methotrexate and anti-TNF-α therapy is a promising option for children with refractory Crohn's colitis.