title: Safety profile of biologic therapy in Polish paediatric patients with Crohn's disease.
abstract: BACKGROUND
  In recent years, monoclonal antibodies against tumor necrosis factor α (TNF-α), infliximab (IFX), and adalimumab (ADA) have gained increasing popularity in Crohn's disease (CD) management. Many clinical trials have shown that biologics are a generally well-tolerated and safe treatment. However, the follow-up time with regards to safety is too short, and data on that issue are still limited.
  
  
  OBJECTIVE
  To report the cumulative safety profile of biologic therapy with IFX and/or ADA, up to 8 years, in Polish children with moderately to severely active CD.
  
  
  METHODS
  We performed a retrospective analysis of 110 children, aged 13.0 ±9.3 years, diagnosed with CD, and treated with IFX and/or ADA, within a period of 8 years between 2005 and 2013. Safety data for all treated patients were collected throughout the entire treatment period and were included in the safety analyses.
  
  
  RESULTS
  The cumulative rates of treatment-related adverse events (AE) (TRAEs) in all patients were 67 events - 43 (64.17%) events for IFX and 24 (35.83%) for ADA, respectively. The majority of TEAEs were mild-to-moderate in intensity. The most frequently reported ones were: anaemia in 17 (20.23%) IFX patients and 9 (23.08%) ADA patients, and mild infections in 9 (10.7%) IFX patients and 5 (12.8%) ADA patients, respectively. We did not report any serious AE (sAE).
  
  
  CONCLUSIONS
  Biologic therapy with infliximab and/or adalimumab is generally well tolerated and safe, and does not cause any sAEs.
authors.affiliation: Department of Paediatrics, Nutrition, and Metabolic Disorders, Children's Memorial Health Institute, Warsaw, Poland.
authors.forename: Edyta
authors.initials: E
authors.lastname: Szymanska
authors.affiliation: Department of Gastroenterology, Hepatology, and Feeding Disorders, Children's Memorial Health Institute, Warsaw, Poland.
authors.forename: Maciej
authors.initials: M
authors.lastname: Dadalski
authors.affiliation: Department of Gastroenterology, Hepatology, and Feeding Disorders, Children's Memorial Health Institute, Warsaw, Poland.
authors.forename: Grzegorz
authors.initials: G
authors.lastname: Oracz
authors.affiliation: Department of Gastroenterology, Hepatology, and Feeding Disorders, Children's Memorial Health Institute, Warsaw, Poland.
authors.forename: Jarosław
authors.initials: J
authors.lastname: Kierkus
keywords: Crohn's disease; biologic therapy; children; safety