Please use this identifier to cite or link to this item:
Title: Cyclosporine A in juvenile idiopathic arthritis. Results of the PRCSG/PRINTO phase IV post marketing surveillance study
Authors: Ruperto, N.
Ravelli, A.
Castell, E.
Gerloni, V.
Haefner, R.
Malattia, C.
Kanakoudi-Tsakalidou, F.
Nielsen, S.
Bohnsack, J.
Gibbas, D.
Rennebohm, R.
Voygioyka, O.
Balogh, Z.
Lepore, L.
Macejkova, E.
Wulffraat, N.
Oliveira, S.
Russo, R.
Buoncompagni, A.
Hilário, Maria Odete Esteves [UNIFESP]
Alpigiani, M. G.
Passo, M.
Lovell, D. J.
Merino, R.
Martini, A.
Giannini, E. H.
Univ Genoa
Ist Gaetano Pini
Rheumakinder Klin Germisch Partenkirchen
Policlin San Matteo
Univ Thessaloniki
Univ Utah
Childrens Hosp
Univ Athens
Natl Inst Rheumatism & Physiotherapy
Univ Trieste
FD Roosvelt Hosp
Wilhelmina Childrens Hosp
Universidade Federal do Rio de Janeiro (UFRJ)
Hosp Pediat Prof Dr Juan P Garrahan
Universidade Federal de São Paulo (UNIFESP)
Hosp Univ La Paz
Keywords: juvenile idiopathic arthritis
juvenile rheumatoid arthritis
juvenile chronic arthritis
cyclosporine A
combination therapy
Issue Date: 1-Sep-2006
Publisher: Clinical & Exper Rheumatology
Citation: Clinical And Experimental Rheumatology. Pisa: Clinical & Exper Rheumatology, v. 24, n. 5, p. 599-605, 2006.
Abstract: ObjectiveTo 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.MethodsAn 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.ResultsA 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.ConclusionThis 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.
ISSN: 0392-856X
Other Identifiers:
Appears in Collections:Artigo

Files in This Item:
There are no files associated with this item.

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.