Advances in Clinical and Experimental Medicine

Title abbreviation: Adv Clin Exp Med
JCR Impact Factor (IF) – 1.736
5-Year Impact Factor – 2.135
Index Copernicus  – 166.39
MEiN – 70 pts

ISSN 1899–5276 (print)
ISSN 2451-2680 (online)
Periodicity – monthly

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Advances in Clinical and Experimental Medicine

2017, vol. 26, nr 1, January-February, p. 51–56

doi: 10.17219/acem/35802

Publication type: original article

Language: English

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Evaluation of the infliximab therapy of severe form of pediatric Crohn’s disease in Poland: Retrospective, multicenter studies

Barbara M. Iwańczak1,A,B,C,D,E,F, Józef Ryżko2,C,E,F, Piotr Jankowski2,B,C,F, Małgorzata Sładek3,B,C,E,F, Agata Wasilewska3,B,C,F, Mariusz Szczepanik4,B,C,F, Edyta Sienkiewicz5,B,C,F, Anna Szaflarska-Popławska6,B,C,F, Sabina Więcek7,B,C,F, Grażyna Czaja-Bulsa8,B,C,F, Bartosz Korczowski9,B,C,F, Jolanta Maślana10,B,C,F, Franciszek Iwańczak1,E, Magdalena Kacperska8,B,C,F

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.
Conclusion. 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.

Key words

Crohn’s disease, infliximab, children

References (23)

  1. Benchimol EI, Fortinsky KJ, Gozdyra P, Van den Heuvel M, Van Limbergen J, Griffiths AM: Epidemiology of pediatric inflammatory bowel disease: A systematic review of international trends. Inflamm Bowel Dis. 2011;17:423–439.
  2. Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine or combination therapy for Crohn’s disease. New Engl J Med. 2010;362:1383–1395.
  3. Daperno M, D’Haens G, Van Assche G, et al. Development and validitation of a new simpified endoscopic activity score for Crohn’s disease: The SES-CD. Gastrointest Endosc. 2004;60:505–512.
  4. De Zoeten EF, Pasternak BA, Mattei P, Kramer RE, Kader HA. Diagnosis and treatment of perianal Crohn disease: NASPGHAN clinical report and consensus statement. J Pediatr Gastroenterol Nutr. 2013;57:401–412.
  5. Ford AC, Khan KJ, Sandborn WJ, Hanauer SB, Moayyedi P. Efficacy of biological therapies in inflammatory bowel disease: Systemic review and meta-analysis. Am J Gastroenterol. 2011;106:644–659.
  6. Glocker EO, Kotlarz D, Boztug K, et al. Inflammatory bowel disease and mutations affecting the interleukin – 10 receptor. N Engl J Med. 2009;361:2033–2045.
  7. Griffiths AM. Specificites of inflammatory bowel disease in childhood. Best Pract Res Clin Gastroenterol. 2004;18:509–523.
  8. Hyams JS, Ferry GD, Mandel FS, et al. Development and validation of a pediatric Crohn’s disease activity index. J Pediatr Gastroenterol Nutr. 1991;12:439–447.
  9. Hyams J, Crandall W, Kugathasan S, et al. Induction and maintenance infliximab therapy for the treatment of moderate-to-severe Crohn’s disease in children. Gastroenterology. 2007;132:863–873.
  10. Hyams JS, Lerer T, Griffiths A, et al. Long-term outcome of maintenance infliximab therapy in children with Crohn’s disease. Inflamm Bowel Dis. 2009;15:816–822.
  11. IBD Working Group of the European Society for Paediatric Gastroenterology Hepatology and Nutrition. Inflammatory bowel disease in children and adolescents: Recommendations for diagnosis – the Porto criteria. J Pediatr Gastroenterol Nutr. 2005;41:1–7.
  12. Iwańczak B, Ryzko J, Kierkuś J, et al. Leczenie biologiczne nie-swoistych zapaleń jelit u dzieci w latach 2004–2013 w Polsce. Pol Merk Lek. 2014;36:312–315.
  13. Kierkuś J, Dadalski M, Szymańska E, et al. The impact of infliximab induction therapy on mucosal healing and clinical remision in Poilsh pedi-atric patients with moderate-to-severe Crohn’s disease. Eur J Gastroenterol Hepatol. 2012;24:495–500.
  14. Kierkuś J, Iwańczak B, Wegner A, et al. A multicenter randomized open label trial to evaluate the efficacy and safety of two different tthera-peutic aproaches for concomitant therapy with infliximab and immunosuppressive agent: withdrawal of immunodulators vs. non-withdrawal of immunomodulators in the maintenance of clinical remission in children with moderate to severe Crohn’s disease. In press.
  15. Levine A, Griffiths A, Markowitz J, et al. Pediatric modification on the Montreal classification of inflammatory bowel disease: The Paris classi-fication. Inflamm Bowel Dis. 2011;17:1314–1321.
  16. Lin Z, Bai Y, Zheng P. Meta-analysis: efficacy and safety of combination therapy of infliximab and immunosuppressives for Crohn’s disease. Eur J Gastroenterol Hepatol. 2001;23:1100–1110.
  17. D’Haens G, Baert F, van Assche G, et al. Early combined immunosuppresion or conventional management in patients with newly diagnosed Crohn’s disease: An open randomised trial. Lancet. 2008;371:660–667.
  18. Ruemmele FM: Pediatric inflammatory bowel diseases: Coming of age, Curr Opinion. Gastroenterol. 2010;25:332–336.
  19. Ruemmele FM, Lachaux A, Cézard JP, et al. Efficacy of infliximab in pediatric Crohn’s disease: A randomized multicenter open-label trial comparing scheduled to on demand maintenance therapy. Inflamm Bowel Dis. 2009;15:388–394.
  20. Ruemmele FM, Veres G, Kolho KL, et al. Consensus guidelines of ECCO/ESPGHAN on the medical management of pediatric Croh’s disease. J Crohn’s Colitis. 2014;8:1179–1207.
  21. Ryżko J, Bartnik W, Socha P, Czubkowski P. Odrębności kliniczne nieswoistych zapaleń jelit u dzieci. Pediatr Pol. 2003;78:355–361.
  22. Schnitzler F, Fidder H, Ferrante M, et al. Mucosal healing predicts long-term outcome of maitenance therapy with infliximab in Crohn’s disease. Inflamm Bowel Dis. 2009; 15:1295–1301.
  23. Vernier-Massouille G, Balde M, Salleron J, et al. Natural history of pediatric Crohn’s disease: A population – based cohort study. Gastroenter-ol. 2008;135:1106–1113.