title: Trial of early aggressive therapy in polyarticular juvenile idiopathic arthritis.
abstract: OBJECTIVE
  To determine whether aggressive treatment initiated early in the course of rheumatoid factor (RF)-positive or RF-negative polyarticular juvenile idiopathic arthritis (JIA) can induce clinical inactive disease within 6 months.
  
  
  METHODS
  Between May 2007 and October 2010, a multicenter, prospective, randomized, double-blind, placebo-controlled trial of 2 aggressive treatments was conducted in 85 children ages 2-16 years with polyarticular JIA of <12 months' duration. Patients received either methotrexate (MTX) 0.5 mg/kg/week (maximum 40 mg) subcutaneously, etanercept 0.8 mg/kg/week (maximum 50 mg), and prednisolone 0.5 mg/kg/day (maximum 60 mg) tapered to 0 by 17 weeks (arm 1), or MTX (same dosage as arm 1), etanercept placebo, and prednisolone placebo (arm 2). The primary outcome measure was clinical inactive disease at 6 months. An exploratory phase determined the rate of clinical remission on medication (6 months of continuous clinical inactive disease) at 12 months.
  
  
  RESULTS
  By 6 months, clinical inactive disease had been achieved in 17 (40%) of 42 patients in arm 1 and 10 (23%) of 43 patients in arm 2 (χ(2)  = 2.91, P = 0.088). After 12 months, clinical remission on medication was achieved in 9 patients in arm 1 and 3 patients in arm 2 (P = 0.053). There were no significant interarm differences in adverse events.
  
  
  CONCLUSIONS
  Although this study did not meet its primary end point, early aggressive therapy in this cohort of children with recent-onset polyarticular JIA resulted in clinical inactive disease by 6 months and clinical remission on medication within 12 months of treatment in substantial proportions of patients in both arms.
authors.affiliation: Seattle Children's Hospital, Seattle, WA, USA. cwallace@u.washington.edu
authors.forename: Carol A
authors.initials: CA
authors.lastname: Wallace
authors.forename: Edward H
authors.initials: EH
authors.lastname: Giannini
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Spalding
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Hashkes
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: O'Neil
authors.forename: Andrew S
authors.initials: AS
authors.lastname: Zeft
authors.forename: Ilona S
authors.initials: IS
authors.lastname: Szer
authors.forename: Sarah
authors.initials: S
authors.lastname: Ringold
authors.forename: Hermine I
authors.initials: HI
authors.lastname: Brunner
authors.forename: Laura E
authors.initials: LE
authors.lastname: Schanberg
authors.forename: Robert P
authors.initials: RP
authors.lastname: Sundel
authors.forename: Diana
authors.initials: D
authors.lastname: Milojevic
authors.forename: Marilynn G
authors.initials: MG
authors.lastname: Punaro
authors.forename: Peter
authors.initials: P
authors.lastname: Chira
authors.forename: Beth S
authors.initials: BS
authors.lastname: Gottlieb
authors.forename: Gloria C
authors.initials: GC
authors.lastname: Higgins
authors.forename: Norman T
authors.initials: NT
authors.lastname: Ilowite
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Kimura
authors.forename: Stephanie
authors.initials: S
authors.lastname: Hamilton
authors.forename: Anne
authors.initials: A
authors.lastname: Johnson
authors.forename: Bin
authors.initials: B
authors.lastname: Huang
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Lovell
mesh_terms: D000293:Adolescent; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001171:Arthritis, Juvenile / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000627:therapeutic use*; D008137:Longitudinal Studies; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000627:therapeutic use*; D011239:Prednisolone / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D011239:Prednisolone; D000068800:Etanercept; D008727:Methotrexate