title: Efficacy and safety of adalimumab in the treatment of Crohn´s disease in children.
abstract: OBJECTIVE
  to describe the efficacy and safety of adalimumab (ADA) in inducing clinical remission and reducing inflammation of intestinal mucosa in children with Crohn´s disease (CD).
  
  
  METHODS
  we carried out a descriptive, observational study with all patients diagnosed with CD and treated with ADA between January 2007 and March 2013. Disease activity was determined using the Pediatric Crohn´s Disease Activity Index (PCDAI), and the degree of mucosa inflammation by fecal calprotectin (FC).
  
  
  RESULTS
  sixteen patients were included. Mean age at diagnosis was 10.6 ± 2.5 years, with a mean age at start of ADA treatment of 12.4 ± 1.8 years, and a median of 1.4 years (IQR 0.5-3) duration from CD diagnosis to start of treatment. Twelve patients were naïve to anti-TNF-a. The PCDAI score at start of ADA treatment was significantly reduced at 12 weeks of follow-up (31.25 IQR 26.8-37.5 vs. 1.2 IQR 0.0-5.0; p = 0.001). Similarly, the FC level decreased at 12 weeks (749 μg/g IQR 514-898 vs. 126 μg/g IQR 67.7-239.2; p = 0.02). Surgery was performed in 4 patients. Adverse events were reported in 4 patients. One patient developed lymphoma at 4 years of ADA treatment in monotherapy.
  
  
  CONCLUSIONS
  ADA has been shown to be effective in children with moderate-to-severe CD. Treatment benefits should be weighed against side effects. Multicenter longitudinal studies with longer follow-up periods are required to determine the true efficacy and safety of long-term ADA treatment.
authors.forename: Víctor Manuel
authors.initials: VM
authors.lastname: Navas-López
authors.forename: Javier
authors.initials: J
authors.lastname: Blasco-Alonso
authors.forename: Francisco
authors.initials: F
authors.lastname: Girón-Fernández-Crehuet
authors.forename: María Juliana
authors.initials: MJ
authors.lastname: Serrano-Nieto
authors.forename: Carlos
authors.initials: C
authors.lastname: Sierra-Salinas
mesh_terms: D000068879:Adalimumab; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003424:Crohn Disease / Q000188:drug therapy*; D005243:Feces; D005260:Female; D006801:Humans; D008297:Male; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D000068879:Adalimumab