title: Efficacy and Safety of Adalimumab for Paediatric Crohn's Disease: A Systematic Review.
abstract: OBJECTIVE
  Adalimumab is well-established therapy for adults with Crohn's disease [CD]. The aim of the study was to systematically assess the published evidence on the efficacy and safety of adalimumab for Crohn's disease in children.
  
  
  METHODS
  MEDLINE, EMBASE, the Cochrane Library, and abstracts from the main gastroenterological meetings in the past 5 years were systematically searched up to July 2015 for randomised controlled trials and observational studies on the efficacy and safety of adalimumab for Crohn's treatment in children and adolescents.
  
  
  RESULTS
  A total of 14 studies [1 randomised controlled trial, 13 case series], altogether including 664 patients [age: 1.9 to 21 years] were available for analysis. The studies differed with respect to patients' characteristics, including percentage of infliximab-naïve patients, disease duration, site of the disease, adalimumab doses, treatment duration, and follow-up period. The pooled remission rates were: 30% [n = 93/309] at 4 weeks, 54% [n = 79/145] at 3 months, 45% [n = 18/40] at 4 months, 42% [n = 146/345] at 6 months, 57% [n = 20/35] at 8 months, and 44% [n = 169/383] at 12 months. Of the total patients, 6% [n = 13/207] were classified as primary non-responders and 12% [n = 69/599] had severe adverse events reported including 2 deaths and 1 medulloblastoma. Withdrawal rate due to adverse events reported in one study was 35% [n = 64/182].
  
  
  CONCLUSIONS
  According to low-quality evidence based mainly on case series, approximately half of children with Crohn's disease on adalimumab therapy achieve remission during the first year of the therapy with reasonable safety profile. There is still a need for high-quality evidence on effectiveness and safety of adalimumab for paediatric Crohn's disease.
authors.affiliation: Department of Paediatrics Medical University of Warsaw, Warsaw, Poland piotrdz@hotmail.com.
authors.forename: Piotr
authors.initials: P
authors.lastname: Dziechciarz
authors.affiliation: Department of Paediatrics Medical University of Warsaw, Warsaw, Poland.
authors.forename: Andrea
authors.initials: A
authors.lastname: Horvath
authors.affiliation: Department of Gastroenterology, Hepatology and Feeding Disorders, Child's Health Memorial Institute, Warsaw, Poland.
authors.forename: Jaroslaw
authors.initials: J
authors.lastname: Kierkuś
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use*; D000293:Adolescent; D002648:Child; D003424:Crohn Disease / Q000188:drug therapy*; D004334:Drug Administration Schedule; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D060828:Induction Chemotherapy; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068879:Adalimumab
keywords: Case series; children; inflammatory bowel disease