title: Growth Improvement with Adalimumab Treatment in Children with Moderately to Severely Active Crohn's Disease.
abstract: Growth failure is common in children with Crohn's disease. The effect of adalimumab (ADA), a fully human antitumor necrosis factor antagonist, on height velocity in pediatric patients with baseline (BL) linear growth impairment in the IMAgINE 1 trial is presented.
  
  
  
  This analysis included female and male patients with growth potential (bone age ≤13 and ≤14 yr, respectively), with BL Pediatric Crohn's disease Activity Index >30, and who failed or were intolerant to conventional therapy. Patients received open-label induction ADA at weeks 0 and 2 by body weight (≥40 kg, 160 and 80 mg and <40 kg, 80 and 40 mg). At week 4, patients were randomized to double-blind high (40 or 20 mg for ≥40 kg or <40 kg) or low dose (20 or 10 mg for ≥40 kg or <40 kg) every other week ADA to week 52. Height velocity z-score was summarized at BL, week 26, and week 52 by patients with BL growth impairment (z-score ≤-1.0) or normal growth (z-score >-1.0).
  
  
  
  ADA therapy significantly improved and normalized growth rate at weeks 26 and 52 in patients with BL growth impairment (median z-score, BL, -3.25; week 26, -0.34; and week 52, 0.21; P < 0.001 versus BL for both), but not in patients with normal growth. Growth improvement was significantly greater at week 26 in week 4 responders to induction therapy compared with nonresponders (median z-score 0.09 versus -2.92; P = 0.02).
  
  
  
  ADA treatment resulted in growth rate normalization as early as week 26 in children with moderately to severely active Crohn's disease and growth impairment.
authors.affiliation: *Department of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children, Toronto, Ontario, Canada; †Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN; ‡Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA; §Department of Pediatric Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands; ‖Department of Pediatrics, Pediatric Gastroenterology, Universite Sorbonne Paris-Cite, Hospital Necker-Enfants Malades, Paris, France; ¶Division of Digestive Diseases, Hepatology and Nutrition, Connecticut Children's Medical Center, Hartford, CT; **AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany; and ††AbbVie Inc., North Chicago, IL.
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Walters
authors.forename: William A
authors.initials: WA
authors.lastname: Faubion
authors.forename: Anne M
authors.initials: AM
authors.lastname: Griffiths
authors.forename: Robert N
authors.initials: RN
authors.lastname: Baldassano
authors.forename: Johanna
authors.initials: J
authors.lastname: Escher
authors.forename: Frank M
authors.initials: FM
authors.lastname: Ruemmele
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Hyams
authors.forename: Andreas
authors.initials: A
authors.lastname: Lazar
authors.forename: Samantha
authors.initials: S
authors.lastname: Eichner
authors.forename: Bidan
authors.initials: B
authors.lastname: Huang
authors.forename: Yao
authors.initials: Y
authors.lastname: Li
authors.forename: Roopal B
authors.initials: RB
authors.lastname: Thakkar
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage*; D000293:Adolescent; D015415:Biomarkers / Q000032:analysis*; D049628:Body Size; D002648:Child; D002657:Child Development; D003424:Crohn Disease / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016014:Linear Models; D016015:Logistic Models; D008297:Male; D012074:Remission Induction; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D014481:United States
chemical_list: D015415:Biomarkers; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab