title: Cyclosporine A in juvenile idiopathic arthritis. Results of the PRCSG/PRINTO phase IV post marketing surveillance study.
abstract: OBJECTIVE
  To investigate the clinical use patterns, clinical effect and safety of cyclosporine A (CSA) in juvenile idiopathic arthritis (JIA) in the setting of routine clinical care.
  
  
  METHODS
  An open-ended, phase IV post marketing surveillance study was conducted among members of the Pediatric Rheumatology Collaborative Study Group (PRCSG) and of the Paediatric Rheumatology International Trials Organisation (PRINTO) to identify patients with polyarticular course JIA who had received CSA during the course of their disease.
  
  
  RESULTS
  A total of 329 patients, half of whom had systemic JIA, were collected in 21 countries. Data were collected during 1240 routine clinic visits. CSA was started at a mean of 5.8 years after disease onset and was given at a mean dose of 3.4 mg/kg/day. The drug was administered in combination with MTX in 61% and along with prednisone in 65% of the patients who were still receiving CSA. Among patients who were still receiving CSA therapy at the last reported visit, remission was documented in 9% of the patients, whereas in 61% of the patients the disease activity was rated as moderate or severe. The most frequent reason for discontinuation of CSA was insufficient therapeutic effect (61% of the patients); only 10% of the patients stopped CSA because of remission. In 17% of the patients, side effects of therapy was given as the primary reason for discontinuation.
  
  
  CONCLUSIONS
  This survey suggests that CSA may have a less favourable efficacy profile than MTX and etanercept, whereas the frequency of side effects may be similar. The exact place of CSA in the treatment of JIA can only be established via controlled clinical trial.
authors.affiliation: IRCCS G. Gaslini, Pediatria II-Reumatologia, PRINTO, Genova, Italy. nicolaruperto@ospedale-gaslini.ge.it
authors.forename: N
authors.initials: N
authors.lastname: Ruperto
authors.forename: A
authors.initials: A
authors.lastname: Ravelli
authors.forename: E
authors.initials: E
authors.lastname: Castell
authors.forename: V
authors.initials: V
authors.lastname: Gerloni
authors.forename: R
authors.initials: R
authors.lastname: Haefner
authors.forename: C
authors.initials: C
authors.lastname: Malattia
authors.forename: F
authors.initials: F
authors.lastname: Kanakoudi-Tsakalidou
authors.forename: S
authors.initials: S
authors.lastname: Nielsen
authors.forename: J
authors.initials: J
authors.lastname: Bohnsack
authors.forename: D
authors.initials: D
authors.lastname: Gibbas
authors.forename: R
authors.initials: R
authors.lastname: Rennebohm
authors.forename: O
authors.initials: O
authors.lastname: Voygioyka
authors.forename: Z
authors.initials: Z
authors.lastname: Balogh
authors.forename: L
authors.initials: L
authors.lastname: Lepore
authors.forename: E
authors.initials: E
authors.lastname: Macejkova
authors.forename: N
authors.initials: N
authors.lastname: Wulffraat
authors.forename: S
authors.initials: S
authors.lastname: Oliveira
authors.forename: R
authors.initials: R
authors.lastname: Russo
authors.forename: A
authors.initials: A
authors.lastname: Buoncompagni
authors.forename: M O
authors.initials: MO
authors.lastname: Hilário
authors.forename: M G
authors.initials: MG
authors.lastname: Alpigiani
authors.forename: M
authors.initials: M
authors.lastname: Passo
authors.forename: D J
authors.initials: DJ
authors.lastname: Lovell
authors.forename: R
authors.initials: R
authors.lastname: Merino
authors.forename: A
authors.initials: A
authors.lastname: Martini
authors.forename: E H
authors.initials: EH
authors.lastname: Giannini
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001171:Arthritis, Juvenile / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D016572:Cyclosporine / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D006304:Health Status; D006801:Humans; D008727:Methotrexate / Q000627:therapeutic use; D011241:Prednisone / Q000627:therapeutic use; D011358:Product Surveillance, Postmarketing; D012074:Remission Induction; D012720:Severity of Illness Index
chemical_list: D018501:Antirheumatic Agents; D016572:Cyclosporine; D011241:Prednisone; D008727:Methotrexate