Maintenance therapy with infliximab for paediatric Crohn's disease: impact on clinical remission and mucosal healing in Polish paediatric patients with severe Crohn's disease

Introduction: Infliximab (IFX) is currently registered for use in Crohn's disease (CD) in children over 7 years of age. So far, there are not enough satisfactory data on maintenance therapy with IFX in children with CD from Eastern and Medium Europe. Aim: Therefore, we carried out this trial in order to assess the benefit of maintenance therapy with infliximab in paediatric patients with active Crohn's disease who responded to induction therapy with 3 doses of infliximab. Material and methods: The study group consisted of 32 CD children aged 14.8; 12.9; 16.3 (median; Q1; Q3) with active Crohn's disease (Crohn's Disease Activity Index (PCDAI) > 30) who have finished induction therapy with infliximab (5 mg/kg) in three repeated infusions. After assessment of remission at week 10, patients were assigned repeat 5 mg/kg infliximab every 8 weeks thereafter until week 46; weeks 14, 22, 30, 38, 46. The clinical activity of the disease by means of the PCDAI and endoscopic activity by means of the SES-CD together with laboratory tests were assessed at week 10 and 50. Adverse events monitoring had been conducted. Descriptive data analysis was performed with Statistica (StatSoft Polska) ver. 5.11 software package. A non-parametric statistical hypothesis test, Mann-Whitney U test, was used to assess whether two independent samples of observations had equally large values. Value of p < 0.05 was regarded as significant. Results: Fourteen patients (44%) had reached clinical remission (defined as PCDAI score <= 10) at week 10, and 23 (72%) at week 50, after the whole maintenance therapy. Comparing data from baseline and week 50, a significant decrease (p < 0.05) was found in PCDAI score (12.5; 6.2; 15.0 (median; Q1; Q3) vs. 5.0; 0.0; 12.5) and a significant increase in body mass index (17.5; 15.4; 19.4 kg/m(2) vs. 18.0; 16.7; 20.0 kg/m(2)). No significant changes in inflammatory parameters (C-reactive protein (CRP) and platelets (PLT)) were reported. We found no significant decrease in SES-CD score (3.5; 0.0; 10.0 vs 4.0; 0.0; 7.5) (median; Q1; Q3), p > 0.05, between initial and control colonoscopy. No adverse event leading to therapy termination was observed. Conclusions: Maintenance therapy with infliximab is efficient in maintaining remission of disease and mucosal healing. Maintenance therapy with infliximab improves nutritional status and growth in children with Crohn's disease.