title: Infliximab therapy in 30 patients with refractory pediatric crohn disease with and without fistulas in The Netherlands.
abstract: OBJECTIVE
  The purpose of this study was to describe the clinical experience with the anti-tumor necrosis factor chimeric monoclonal antibody, infliximab, in pediatric patients with Crohn disease in The Netherlands.
  
  
  METHODS
  Descriptive.
  
  
  METHODS
  Clinical response and adverse effects of infliximab were recorded for pediatric patients with Crohn disease treated from October 1992 to January 2003.
  
  
  RESULTS
  Thirty patients (aged 7-18 years) with refractory Crohn disease (with or without severe fistulas) were treated with infliximab. Patients were treated with up to 30 infusions. Mean follow-up was 25.3 months. A total of 212 infusions were administered. Thirteen patients had refractory Crohn disease without fistulas. Six patients showed good long-term response to infliximab treatment (defined as clinical index < or =10 points). Sixteen patients had refractory Crohn disease with draining fistulas. Nine showed good long-term response (closure or nonproductiveness of fistulas). One patient with metastatic Crohn disease in the skin had a good long-term response. Six patients developed an allergic reaction during infusion. In one patient, the allergic reaction occurred after an infliximab-free interval of 9 years. One patient died of sepsis.
  
  
  CONCLUSIONS
  Infliximab was an effective therapy in 53% of patients with refractory pediatric Crohn disease, with or without fistulas. Approximately half of the patients become unresponsive to infliximab therapy. Randomized controlled studies are mandatory to assess long-term efficacy and safety to define the optimal therapeutic strategy of infliximab therapy in children with Crohn disease.
authors.affiliation: Emma Children's Hospital/Academic Medical Centre, Amsterdam, The Netherlands. l.deridder@amc.uva.nl
authors.forename: Lissy
authors.initials: L
authors.lastname: de Ridder
authors.forename: Johanna C
authors.initials: JC
authors.lastname: Escher
authors.forename: Jan
authors.initials: J
authors.lastname: Bouquet
authors.forename: Joachim J
authors.initials: JJ
authors.lastname: Schweizer
authors.forename: Edmond H H M
authors.initials: EH
authors.lastname: Rings
authors.forename: Jules J M
authors.initials: JJ
authors.lastname: Tolboom
authors.forename: Roderick H J
authors.initials: RH
authors.lastname: Houwen
authors.forename: Obbe F
authors.initials: OF
authors.lastname: Norbruis
authors.forename: Bert H F
authors.initials: BH
authors.lastname: Derkx
authors.forename: Jan A J M
authors.initials: JA
authors.lastname: Taminiau
mesh_terms: D000293:Adolescent; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D015331:Cohort Studies; D003424:Crohn Disease / Q000150:complications / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab; D007262:Infusions, Intravenous; D007412:Intestinal Fistula / Q000150:complications / Q000188:drug therapy*; D008297:Male; D009426:Netherlands; D012003:Rectal Fistula / Q000150:complications / Q000188:drug therapy; D012006:Rectovaginal Fistula / Q000150:complications / Q000188:drug therapy; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000276:immunology / Q000502:physiology
chemical_list: D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab