Assessment of induction therapy with infliximab in children with moderate to severe ulcerative colitis: a multi-center study.

The Aim Of The Study: Assessment of clinical and endoscopic efficacy of induction therapy with infliximab in children with ulcerative colitis.

Material And Methods: This is a retrospective analysis of medical records of pediatric patients with moderate to severe UC who had received at least one infusion of infliximab in Polish pediatric academic clinical centers from 2003 to 2013. The primary endpoint was clinical remission rate at week 10, (PUCAI score <10 points) while the secondary endpoints were: clinical response rate (>19-points decrease in PUCAI), mucosal response rate (defined as an improvement of the Baron score), and mucosal healing rate (Baron score 0 or 1).

Results: 44 patients, at mean age of 14±3.9 years, were included into the study. 38 (86%) patients completed induction therapy regimen with infliximab and were finally included into the analysis. Clinical response and remission rates at week 10 there were 36% and 25% respectively. There was significant drop of PUCAI (58.31±15.5 vs. 24.23±23.83) and Baron score (2.63±0.49 vs. 1.44±0.99) at this time point. Mucosal response and mucosal healing rate were 57% and 48% respectively. Infliximab failure defined as non-clinical and non-mucosal response at week 10, occurred in 16 patients. Infliximab-associated adverse events occurred in 3 patients, with all severe hypersensitivity reactions to infliximab.

Conclusions: Infliximab induction therapy was safe and effective in Polish moderate to severe UC pediatric patients with 50% rate of mucosal improvement. However, clinical response rate was lower than previously reported.