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P476. Induction therapy with infliximab in children with moderate to severe ulcerative colitis

M. Szychta1, M. Dadalski1, P. Landowski2, B. Klincewicz3, M. Sladek4, K. Karolewska-Bochenek5, G. Czaja-Bulsa6, E. Jarocka-Cyrta7, B. Korczowski8, J. Kierkus1, 1The Children's Memorial Health Institute, Department of Gastroenterology, Hepatology and Feeding Disorders, Warsaw, Poland, 2Medical University of Gdansk, Chair and Department of Pediatrics, Pediatric Gastroenterology, Hepatology and Nutrition, Gdansk, Poland, 3Poznan University of Medical Sciences, 1st Chair of Pediatrics, Department of Pediatric Gastroenterology and Metabolism, Poznan, Poland, 4Jagiellonian University School of Medicine, Department of Pediatrics, Gastroenterology and Nutrition, Cracow, Poland, 5Medical University of Warsaw, Department of Pediatric Gastroenterology and Nutrition, Warsaw, Poland, 6Pediatric Nursery Unit of Pomeranian Medical University, Division of Pediatrics, Gastroenterology and Rheumatology of Zdroje Hospital in Szczecin, Szczecin, Poland, 7Medical University of Bialystok, Department of Pediatrics, Gastroenterology and Allergology, Bialystok, Poland, 8Medical College. University of Rzeszow, Department of Pediatrics. State Hospital no 2, Rzeszow, Poland

Background

Ulcerative colitis (UC) in children has a variable clinical course ranging from mild to severe phenotype. Treatment of UC depends on disease activity determined by Pediatric Ulcerative Colitis Activity Index (PUCAI) and the extent of mucosal inflammation assessing in colonoscopy. Some clinical data from USA and Western Europe demonstrate that infliximab is efiicient in children with moderate to severe ulcerative colitis and reduces the quantity of colectomies in this group. The aim of the study was to assess the efficacy and safety of induction therapy with infliximab in Polish children with moderate to severe ulcerative colitis.

Methods

The retrospective analysis of 44 patients (23F, 21M) aged 14±3.9 y [mean±SD] with moderate to severe ulcerative colitis (PUCAI >30 points; 58.8±15.1 points [mean±SD]) and endoscopic evaluation who received induction therapy with infliximab 5 mg/kg at weeks 0, 2, and 6. According to Paris classification the endoscopic extension were: E1–0pts (0%); E2–11pts (25%); E3–10pts (23%); E4–23pts (52%); and the severity S0–7pts (16%); S1–37pts (84%). Endoscopic severity according to Baron classification was: Baron1–1pts (2%); Baron2–17pts (39%); Baron3–26pts (59%). Clinical (PUCAI score) and endoscopical (Baron classification) evaluations were performed at week 10 after 3 doses of infliximab. The primary endpoints were: clinical response defined as decrease of PUCAI >19, mucosal response defined as improvement in Baron classification and mucosal remission defined as Baron classification 0 (no endoscopic changes). The secondary endpoint was clinical remission defined as PUCAI <10.

Results

Twenty-eight out of the 44 (64%) patients had clinical response, 25 out of 44 (57%) had mucosal response and 5 out of 44 (11%) had mucosal remission. 6 patients did not receive three doses of infliximab, 3 had allergic shock and 3 had to have colectomy performed. Eleven out of the 44 (25%) patients had clinical remission at week 10.

Conclusion

Infliximab is efficient and safe as an induction therapy in children with moderate to severe ulcerative colitis and improves mucosal appearance in about 60% cases. Clinical remission is not equivalent to mucosal remission in children with UC.