title: A Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Adalimumab in Pediatric Patients With Enthesitis-Related Arthritis.
abstract: OBJECTIVE
  Enthesitis-related arthritis (ERA) is a juvenile idiopathic arthritis (JIA) category, primarily affecting entheses and peripheral joints. This study evaluated efficacy, safety, and pharmacokinetics of adalimumab versus placebo in patients with ERA.
  
  
  METHODS
  This is a phase III, multicenter, randomized double-blind study in patients ages ≥6 to <18 years with ERA treated with adalimumab (24 mg/m(2) , maximum dose 40 mg every other week) or placebo for 12 weeks, followed by up to 192 weeks of open-label adalimumab. The primary end point was percent change from baseline in number of active joints with arthritis (AJC) at week 12. Samples were collected to determine adalimumab serum concentrations. Adverse events (AEs) were assessed throughout the study.
  
  
  RESULTS
  Forty-six patients were randomized (31 adalimumab/15 placebo). At baseline, mean age was 12.9 years, mean duration of ERA symptoms was 2.6 years, mean AJC was 7.8, and mean enthesitis count was 8.1. Mean percent change from baseline in AJC at week 12 was greater in the adalimumab group versus placebo (-62.6% versus -11.6%; P = 0.039). Most secondary variables favored adalimumab versus placebo at week 12. Treatment response further increased with continued adalimumab therapy through week 52. Mean steady-state adalimumab serum concentrations were 7.5-11.8 μg/ml, similar to patients age ≥2 years with polyarticular JIA. AE rates were similar between placebo and adalimumab: any AE (53.3% versus 67.7%), serious AEs (0% versus 3.2%), and infectious AEs (20.0% versus 29.0%).
  
  
  CONCLUSIONS
  Adalimumab reduced signs and symptoms of ERA at week 12, with improvement sustained through week 52. The safety profile was consistent with previous adalimumab studies.
authors.affiliation: Hospital General de Mexico, Universidad Nacional Autonoma de Mexico, Mexico City, Mexico.
authors.forename: Rubén
authors.initials: R
authors.lastname: Burgos-Vargas
authors.affiliation: The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Shirley M L
authors.initials: SM
authors.lastname: Tse
authors.affiliation: Asklepios Klinik Sankt Augustin, Sankt Augustin, Germany.
authors.forename: Gerd
authors.initials: G
authors.lastname: Horneff
authors.affiliation: AbbVie, North Chicago, Illinois.
authors.forename: Aileen L
authors.initials: AL
authors.lastname: Pangan
authors.affiliation: AbbVie Deutschland, Ludwigshafen, Germany.
authors.forename: Jasmina
authors.initials: J
authors.lastname: Kalabic
authors.affiliation: AbbVie, North Chicago, Illinois.
authors.forename: Sandra
authors.initials: S
authors.lastname: Goss
authors.affiliation: AbbVie Deutschland, Ludwigshafen, Germany.
authors.forename: Kristina
authors.initials: K
authors.lastname: Unnebrink
authors.affiliation: AbbVie, North Chicago, Illinois.
authors.forename: Jaclyn K
authors.initials: JK
authors.lastname: Anderson
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use*; D000293:Adolescent; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001171:Arthritis, Juvenile / Q000175:diagnosis* / Q000188:drug therapy*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D000068879:Adalimumab