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P302. The impact of induction and maintenance therapy with infliximab on mucosal healing and clinical remission in Polish pediatric patients with moderate to severe Crohn's disease

J. Kierkus1, E. Szymanska1, M. Dadalski1, A. Wegner1, G. Oracz1, M. Gorczewska1, S. Szymanska1, M. Woynarowski1, J. Ryzko1

1The Children's Memorial Health Institute, Warsaw, Poland

Background: Infliximab (IFX) is currently registered for use in Crohn's disease (CD) in children over 7 years of age. Healing of mucosal lesions seems to be most important end point of the successful therapy with biological agents. The aim of this study was to assess clinical efficacy and the impact of induction therapy with three doses of IFX on mucosal healing in children with CD and to assess the benefit of maintenance therapy with IFX in paediatric patients with active Crohn's disease who responded to induction therapy with 3 doses of infliximab.

Methods: 66 children aged 14.06; 12.9; 16.3 [median; Q1; Q3] with moderate to severely active Crohn's Disease were included into the study. Patients received infliximab (5 mg/kg) in three repeated infusions at 0, 2, 6 weeks. The disease clinical activity was assessed by (PCDAI) and endoscopic activity was scored using the Simple Endoscopic Score (SES-CD) at baseline and at week 10. Those patients who have achieved the remission at week 10 (n = 32) were qualified to the maintenance therapy with repeat 5 mg/kg infliximab every 8 weeks. The PCDAI and the SES-CD together with laboratory tests were performed at week 10 and 50.

Results: Induction therapy: 22 (33%) of patients have reached clinical remission, 26 (39%) had clinical response. The significant decreases (p < 0.05) in PCDAI [median; Q1; Q3]: 52.5; 45.0; 57.5 vs. 15.0; 10.0; 30.0; CRP: 1.6; 0.3; 3.5 vs. 0.3; 0.2; 2.1, platelets level 368.0; 287.0; 506.0 vs. 309.0; 263.0; 459.0 and significant increase in BMI: 17.5; 15.4; 19;4 vs. 18.0; 16.7; 20.0 were found when data from baseline and week 10 were compared. Significant decrease in SES-CD score (p < 0.05) [median; Q1; Q3] between initial and control colonoscopy (18; 12; 22 vs 7.5; 1; 15.0) was observed. Maintenance therapy: 14 (44%) patients has reached clinical remission (defined as PCDAI score ≤10) at week 10 and 23 (72%) at week 50 – after the whole maintenance therapy. We have 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.

Conclusions: Biological therapy with infliximab allows to achieve mucosal healing in pediatric patients with Crohn's disease.

Induction therapy with infliximab was clinically effective in 72% pediatric patients with Crohn's disease. Maintenance therapy with infliximab is efficient in maintening remission of disease and mucosal healing.