title: Adalimumab with or without methotrexate in juvenile rheumatoid arthritis.
abstract: BACKGROUND
  Tumor necrosis factor (TNF) has a pathogenic role in juvenile rheumatoid arthritis. We evaluated the efficacy and safety of adalimumab, a fully human monoclonal anti-TNF antibody, in children with polyarticular-course juvenile rheumatoid arthritis.
  
  
  METHODS
  Patients 4 to 17 years of age with active juvenile rheumatoid arthritis who had previously received treatment with nonsteroidal antiinflammatory drugs underwent stratification according to methotrexate use and received 24 mg of adalimumab per square meter of body-surface area (maximum dose, 40 mg) subcutaneously every other week for 16 weeks. We randomly assigned patients with an American College of Rheumatology Pediatric 30% (ACR Pedi 30) response at week 16 to receive adalimumab or placebo in a double-blind fashion every other week for up to 32 weeks.
  
  
  RESULTS
  Seventy-four percent of patients not receiving methotrexate (64 of 86) and 94% of those receiving methotrexate (80 of 85) had an ACR Pedi 30 response at week 16 and were eligible for double-blind treatment. Among patients not receiving methotrexate, disease flares (the primary outcome) occurred in 43% of those receiving adalimumab and 71% of those receiving placebo (P=0.03). Among patients receiving methotrexate, flares occurred in 37% of those receiving adalimumab and 65% of those receiving placebo (P=0.02). At 48 weeks, the percentages of patients treated with methotrexate who had ACR Pedi 30, 50, 70, or 90 responses were significantly greater for those receiving adalimumab than for those receiving placebo; the differences between patients not treated with methotrexate who received adalimumab and those who received placebo were not significant. Response rates were sustained after 104 weeks of treatment. Serious adverse events possibly related to adalimumab occurred in 14 patients.
  
  
  CONCLUSIONS
  Adalimumab therapy seems to be an efficacious option for the treatment of children with juvenile rheumatoid arthritis. (ClinicalTrials.gov number, NCT00048542.)
authors: Cincinnati Children's Hospital Medical Center, Division of Rheumatology, Location E, Rm. 2-129, MLC 4010, 3333 Burnet Ave., Cincinnati, OH 45229-3039, USA. daniel.lovell@cchmc.org
authors: Daniel J
authors: DJ
authors: Lovell
authors: Nicolino
authors: N
authors: Ruperto
authors: Steven
authors: S
authors: Goodman
authors: Andreas
authors: A
authors: Reiff
authors: Lawrence
authors: L
authors: Jung
authors: Katerina
authors: K
authors: Jarosova
authors: Dana
authors: D
authors: Nemcova
authors: Richard
authors: R
authors: Mouy
authors: Christy
authors: C
authors: Sandborg
authors: John
authors: J
authors: Bohnsack
authors: Dirk
authors: D
authors: Elewaut
authors: Ivan
authors: I
authors: Foeldvari
authors: Valeria
authors: V
authors: Gerloni
authors: Jozef
authors: J
authors: Rovensky
authors: Kirsten
authors: K
authors: Minden
authors: Richard K
authors: RK
authors: Vehe
authors: L Wagner
authors: LW
authors: Weiner
authors: Gerd
authors: G
authors: Horneff
authors: Hans-Iko
authors: HI
authors: Huppertz
authors: Nancy Y
authors: NY
authors: Olson
authors: John R
authors: JR
authors: Medich
authors: Roberto
authors: R
authors: Carcereri-De-Prati
authors: Melissa J
authors: MJ
authors: McIlraith
authors: Edward H
authors: EH
authors: Giannini
authors: Alberto
authors: A
authors: Martini
mesh_terms: D000068879:Adalimumab; D000293:Adolescent; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001171:Arthritis, Juvenile / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab; D008727:Methotrexate