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P525. Efficacy infliximab with immunomodulator and infliximab alone of maintenance therapy in children with Crohn's disease – multicenter randomized study

J. Kierkus1, B. Iwanczyk2, A. Wegner1, M. Dadalski1, U. Grzybowska-Chlebowczyk3, I. Lazowska4, J. Maslana5, E. Toporowska-Kowalska6, G. Czaja-Bulsa7, G. Mierzwa8, B. Korczowski9, E. Czkwianianc10, A. Zabka11, E. Szymanska1, E. Krzesiek2, S. Wiecek12, M. Sladek13, 1The Childrens Memorial Health Institute, Gastroenterology, Hepatology and Immunology, Warsaw, Poland, 2Medical University of Wroclaw, Department of Pediatrics, Gastroenterology and Nutrition, Wroclaw, Poland, 3Medical University of Silesia, Gastroenterology Unit, Upper-Silesian Child Health Care Centre in Katowice, Department of Paediatrics, Katowice, Poland, 4Medical University of Warsaw, Department of Pediatric Gastroneterology and Nutrition, Warsaw, Poland, 5Wl. Buszkowski Kielce Province Children's Hospital, Kielce, Poland, Kielce, Poland, 6Medical University of Lodz Poland, Department of Paediatric Allergology, Gastroenterology and Nutrition, Lodz, Poland, 7Pomeranian Medical University, Division of Paediatrics, Gastroenterology and Rheumatology of Zdroje Hospital in Szczecin, Paediatric Nursery Unit, Szczecin, Poland, 8Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Poland, Chair and Department of Pediatrics, Allergology and Gastroenetrology, Bydgoszcz, Poland, 9State Hospital. Medical College. University of Rzeszów. Poland, Department of Pediatrics, Rzeszow, Poland, 10Polish Mother's Memorial Hospital. Research Institute Lodz, Gastroenterology and Pediatric Depts, Lodz, Poland, 11Medical University of Silesia, Zabrze, Department of Pediatrics, Zabrze, Poland, 12Medical University of Silesia, Gastroenterology Unit, Upper-Silesian Child Health Care Centre in Katowice, The Department of Paediatrics, Katowice, Poland, 13Jagiellonian University School of Medicine, Krakow, Department of Pediatrics, Gastroenterology and Nutrition, Krakow, Poland

Background

Optimal use of biologics in Crohn's disease (CD) requires balance between benefits and risk, and concern of serious side effects may question the concomitant immunomodulators use in pediatric patients. The study (registration no NCT01559142) was conducted to compare the efficacy of two infliximab maintenance regiments: (1) infliximab alone and (2) infliximab with immunomodulator in pediatric patients with moderate to severe active CD.

Methods

Ninety-nine children (62 boys and 37 girls) aged 14.54±2.61 years with PCDAI >30 pts and endoscopic evaluation performed were involved to the study and received induction therapy with infliximab 5 mg/kg at weeks 0, 2, and 6. Clinical (PCDAI score) and endoscopical (SES CD score) evaluations were performed at week 10 and patients with clinical response (decrease of PCDAI ≥15 AND PCDAI <30) and/or remission (PCDAI ≤10) were randomized to Group l receiving infliximab 5 mg/kg every 8 weeks with immunomodulator until Week 54 (n = 45) or Group II receiving infliximab 5 mg/kg every 8 weeks with immunomodulator stopped at Week 26 (n = 39). Clinical (PCDAI score) and endoscopical (SES CD score) were performed at week 54 in both groups. Primary endpoint was loss of clinical response defined as increase of PCDAI >15 points or PCDAI >30. Secondary endpoints were: necessity to increase/change maintenance therapy and relapse of mucosal response defined as increase of SES CD score.

Results

84 out of 99 (85%) pts had response, and 58 (59%) clinical remission. 78 out of 84 (93%) pts with clinical response had also mucosal response defined as decrease of SES CD score and 26 out of 84 (31%) mucosal remission defined as SES CD = 0 points. 2 out of 45 (4%) pts in Group I and 2 out of 39 pts (5%) in Group II had loss of clinical response at Week 54 (non significant – NS). The increase/change of maintenance therapy was necessary in 13 out of 45 pts (29%) in Group I and 11 out of 39 (28%) in Group II (NS). Mucosal deterioration (increase of SES CD score) was found in 13 out of 45 pts in Group I (29%) and 11 out of 39 pts in Group II (28%) (NS).

Conclusion

Both regimens of infliximab maintenance therapy – with and without concomitant immunomodulator – are equally efficient in the clinical and endoskcopic response rate in children with moderate to severe active CD.