Infliximab plus azathioprine is more effective than azathioprine alone in achieving mucosal healing in pediatric patients with Crohn's disease

Aim Over the past few years, mucosal healing (MH) has emerged as a promising goal in the treatment of pediatric patients with Crohn's disease (CD). The study aim was to assess if the combination therapy of infliximab (IFX) + azathioprine (AZA) was more effective than AZA therapy alone in achieving mucosal healing in pediatric patients with CD. Methods Newly-diagnosed pediatric patients with CD at the Department of Pediatrics, University Hospital in Hradec Kralove were retrospectively recruited (2000-2014). The patients were divided into two groups according to the therapy: A) IFX + AZA ± corticosteroids (CS) ± 5-aminosalicylic acid (5-ASA) (N=16); and B) AZA ± CS ± 5-ASA (n = 40). The patients were also divided into two groups "MH" and "No MH" according to MH status. MH was defined as complete endoscopic disappearance of all mucosal ulcerations (including aphthous ulcerations) and the absence of any signs of mucosal inflammation (erythema, edema) in the terminal ileum and the large bowel. Results From 56 patients, MH was observed in 56% (9/16) patients treated with combined therapy in comparison with 15 % (6/40) patients in the AZA group, p = 0.006. The mean dose of AZA in both groups was 2.0 ± 0.4 mg/kg/day. We observed 8 adverse events (AE) in 7 patients (44%) from the IFX+AZA group. AE were less commonly presented in the AZA group (4/40 (10%), p = 0.002). Conclusions Combined therapy (IFX+AZA) was more effective in achieving MH in pediatric CD compared to treatment with azathioprine alone.