title: CDP571, a humanized anti-tumor necrosis factor-alpha monoclonal antibody in pediatric Crohn's disease.
abstract: OBJECTIVE
  The objectives of this study were to evaluate the safety, pharmacokinetics, and immunogenicity of CDP571 in pediatric patients with Crohn's disease.
  
  
  METHODS
  A single dose of CDP571, 10 mg/kg, was administered by infusion to pediatric patients (aged 6-17 years) with Crohn's disease in a 12-week open-label study. Adverse events were monitored during infusion and throughout the study. Plasma concentrations of CDP571 and standard clinical and laboratory values were assessed. Changes in disease activity were monitored using the Pediatric Crohn's Disease Activity Index (PCDAI).
  
  
  RESULTS
  Twenty patients were enrolled and stratified by age: 6 to 13 (n = 9) and 14 to 17 years (n = 11). Fourteen patients experienced adverse events, which were mainly mild or moderate in intensity. The plasma concentration profile was consistent with a half-life of approximately 2 weeks. At Week 4, 4 patients in the 6- to 13-year-old group and 2 patients in the 14- to 17-year-old group had detectable anti-CDP571 antibodies. By Week 2, 7 patients in the 6- to 13-year-old group and 6 patients in the 14- to 17-year-old group had responded to treatment (reduction in PCDAI score >10 points).
  
  
  CONCLUSIONS
  In conclusion, CDP571 was well tolerated among pediatric patients with Crohn's disease.
authors.affiliation: Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, USA. mamula@email.chop.edu
authors.forename: Petar
authors.initials: P
authors.lastname: Mamula
authors.forename: Stanley A
authors.initials: SA
authors.lastname: Cohen
authors.forename: George D
authors.initials: GD
authors.lastname: Ferry
authors.forename: Barbara S
authors.initials: BS
authors.lastname: Kirschner
authors.forename: Harland S
authors.initials: HS
authors.lastname: Winter
authors.forename: Alison
authors.initials: A
authors.lastname: Innes
authors.forename: Jatin
authors.initials: J
authors.lastname: Patel
authors.forename: Robert N
authors.initials: RN
authors.lastname: Baldassano
mesh_terms: D000293:Adolescent; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002648:Child; D003424:Crohn Disease / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D014481:United States
chemical_list: D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; C402162:CDP 571