Barbara M Iwańczak1, Józef Ryżko2, Piotr Jankowski2, Małgorzata Sładek3, Agata Wasilewska3, Mariusz Szczepanik4, Edyta Sienkiewicz5, Anna Szaflarska-Popławska6, Sabina Więcek7, Grażyna Czaja-Bulsa8, Bartosz Korczowski9, Jolanta Maślana10, Franciszek Iwańczak1, Magdalena Kacperska8. 1. Department and Clinic of Paediatrics, Gastroenterology and Nutrition, Wroclaw Medical University, Poland. 2. Children's Memorial Health Institute, Warsaw, Poland. 3. Department of Pediatrics, Gastroenterology and Nutrition, Jagiellonian University School of Medicine, Kraków, Poland. 4. Department of Pediatric Gastroenterology and Metabolic Disorders, Poznan University of Medical Science, Poland. 5. Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw, Poland. 6. Department of Pediatrics, Allergology and Gastroenterology, Collegium Medicum, Nicolaus Copernicus University of Toruń, Bydgoszcz, Poland. 7. Department of Pediatrics, Medical University of Silesia, Gastroenterology Unit, Upper Silesian Child Health Care Center, Katowice, Poland. 8. Pediatric Nursery Unit of Pomeranian Medical University, Division of Pediatrics, Gastroenterology and Reumatology of Zdroje Hospital, Szczecin, Poland. 9. Department of Pediatrics, State Hospital, Medical College, Rzeszów, Poland. 10. Province Children's Hospital, Kielce, Poland.
Abstract
BACKGROUND: Registration of infliximab in Poland has increased chances to induce clinical remission and mucosal healing in the severe form of pediatric Crohn's disease. OBJECTIVES: The aim of this retrospective study was to assess the results and safety of infliximab therapy in the severe form of pediatric Crohn's disease. MATERIAL AND METHODS: The study included 153 children with severe form of non-fistulizing Crohn's disease treated with infliximab. The clinical activity of Crohn's disease was assessed according to PCDAI scale, endoscopic scoring was graded according to SES-CD, body mass was measured with body mass index (BMI). Infliximab was administered at the dose 5 mg/kg body mass in the 0.2 and 6th week, and then, after clinical response, every 8 for the period of 12 months. RESULTS: One hundred thirty-six children (88.89%) achieved clinical response after induction therapy and 75.21% of children after the maintenance therapy. 39.68% of children achieved remission as graded with endoscopic scoring SES-CD. There was a statistically significant increase in body weight following the treatment. Side effects such as anaphylaxis, rash, and the activation of EBV infection appeared in 9 children at the time of infliximab injection. In other children the drug was well tolerated. CONCLUSIONS: Induction and maintenance therapy with infliximab resulted in clinical remission of Crohn's disease in 75.21% of children, and in the intestinal mucosa healing in 39.68% of children.
BACKGROUND: Registration of infliximab in Poland has increased chances to induce clinical remission and mucosal healing in the severe form of pediatric Crohn's disease. OBJECTIVES: The aim of this retrospective study was to assess the results and safety of infliximab therapy in the severe form of pediatric Crohn's disease. MATERIAL AND METHODS: The study included 153 children with severe form of non-fistulizing Crohn's disease treated with infliximab. The clinical activity of Crohn's disease was assessed according to PCDAI scale, endoscopic scoring was graded according to SES-CD, body mass was measured with body mass index (BMI). Infliximab was administered at the dose 5 mg/kg body mass in the 0.2 and 6th week, and then, after clinical response, every 8 for the period of 12 months. RESULTS: One hundred thirty-six children (88.89%) achieved clinical response after induction therapy and 75.21% of children after the maintenance therapy. 39.68% of children achieved remission as graded with endoscopic scoring SES-CD. There was a statistically significant increase in body weight following the treatment. Side effects such as anaphylaxis, rash, and the activation of EBV infection appeared in 9 children at the time of infliximab injection. In other children the drug was well tolerated. CONCLUSIONS: Induction and maintenance therapy with infliximab resulted in clinical remission of Crohn's disease in 75.21% of children, and in the intestinal mucosa healing in 39.68% of children.