Infliximab, immunomodulators and treatment failures in pediatric and adolescent patients with Crohn's disease - a nationwide cohort study.

BACKGROUND AND AIMS In pediatric patients with Crohn's disease, the role of combination therapy, infliximab plus immunomodulators (thiopurine or methotrexate), is debated and data are sparse. We examined whether infliximab plus immunomodulators, compared to infliximab therapy alone, reduce the risk of treatment failure measured by intestinal surgery or switching type of anti-TNFα agent within 24 months. DESIGN Using Danish registries, we identified patients with Crohn's disease, aged ≤20 years at the time of the first infliximab treatment and retrieved data on their co-medications. We used Cox regression models to examine surgery or switching type of anti-TNFα agent from 1 January 2003 through 31 December 2015. RESULTS We included 581 patients. The two-year cumulative percentage of surgery was 8.5% among patients receiving combination therapy and 14.5% in those receiving infliximab alone. The adjusted two-year hazard ratio (HR) of surgeries was 0.53 (95% CI 0.32-0.88) in patients receiving combination therapy, compared to patients receiving infliximab alone. When examining a switch of anti-TNFα we included 536 patients. Within two years, 18.3% experienced a switch among patients receiving combination therapy and 24.8% in patients treated with infliximab alone, corresponding to an adjusted HR of 0.66 (CI 95%: 0.45-0.97) in patients receiving combination therapy. CONCLUSIONS The HR of intestinal surgeries and the risk of a switch to another anti-TNFα was reduced in pediatric and adolescents patients receiving combination therapy, compared to patients only receiving infliximab. These results suggest a benefit for infliximab therapy combined with immunomodulators, but need to be confirmed in data with additional clinical information.