title: Long-term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn's Disease.
abstract: IMAgINE 1 assessed 52-week efficacy and safety of adalimumab in children with moderate to severe Crohn's disease. Long-term efficacy and safety of adalimumab for patients who entered the IMAgINE 2 extension are reported.
  
  
  
  Patients who completed IMAgINE 1 could enroll in IMAgINE 2. Endpoints assessed from weeks 0 to 240 of IMAgINE 2 were Pediatric Crohn's Disease Activity Index remission (Pediatric Crohn's Disease Activity Index ≤ 10) and response (Pediatric Crohn's Disease Activity Index decrease ≥15 from IMAgINE 1 baseline) using observed analysis and hybrid nonresponder imputation (hNRI). For hNRI, discontinued patients were imputed as failures unless they transitioned to commercial adalimumab (with study site closure) or adult care, where last observation was carried forward. Corticosteroid-free remission in patients receiving corticosteroids at IMAgINE 1 baseline, discontinuation of immunomodulators (IMMs) in patients receiving IMMs at IMAgINE 2 baseline, and linear growth improvement were reported as observed. Adverse events were assessed for patients receiving ≥1 adalimumab dose in IMAgINE 1 and 2 through January 2015.
  
  
  
  Of 100 patients enrolled in IMAgINE 2, 41% and 48% achieved remission and response (hNRI) at IMAgINE 2 week 240. Remission rates were maintained by 45% (30/67, hNRI) of patients who entered IMAgINE 2 in remission. At IMAgINE 2 week 240, 63% (12/19) of patients receiving corticosteroids at IMAgINE 1 baseline achieved corticosteroid-free remission and 30% (6/20) of patients receiving IMMs at IMAgINE 2 baseline discontinued IMMs. Adalimumab treatment led to growth velocity normalization. No new safety signals were identified.
  
  
  
  Efficacy and safety profiles of prolonged adalimumab treatment in children with Crohn's disease were consistent with IMAgINE 1 and adult Crohn's disease adalimumab trials.
authors.affiliation: *Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota; †Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, New York; ‡Pediatric Gastroenterology Unit, Department of Pediatrics, Universite Sorbonne Paris-Cite, Hospital Necker-Enfants Malades, Paris, France; §Department of Pediatric Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, Netherlands; ‖Pediatric Gastroenterology, Goryeb Children's Hospital/Atlantic Health, Morristown, New Jersey; ¶Division of Digestive Diseases, Connecticut Children's Medical Center, Hartford, Connecticut; **AbbVie Inc., North Chicago, Illinois; and ††AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
authors.forename: William A
authors.initials: WA
authors.lastname: Faubion
authors.forename: Marla
authors.initials: M
authors.lastname: Dubinsky
authors.forename: Frank M
authors.initials: FM
authors.lastname: Ruemmele
authors.forename: Johanna
authors.initials: J
authors.lastname: Escher
authors.forename: Joel
authors.initials: J
authors.lastname: Rosh
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Hyams
authors.forename: Samantha
authors.initials: S
authors.lastname: Eichner
authors.forename: Yao
authors.initials: Y
authors.lastname: Li
authors.forename: Nattanan
authors.initials: N
authors.lastname: Reilly
authors.forename: Roopal B
authors.initials: RB
authors.lastname: Thakkar
authors.forename: Anne M
authors.initials: AM
authors.lastname: Robinson
authors.forename: Andreas
authors.initials: A
authors.lastname: Lazar
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage*; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D003424:Crohn Disease / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy / Q000379:methods / Q000706:statistics & numerical data*; D008297:Male; D013995:Time; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D000068879:Adalimumab