Cyclosporine A in juvenile idiopathic arthritis. Results of the PRCSG/PRINTO phase IV post marketing surveillance study

Nicolino Ruperto, Angelo Ravelli, E. Castell, Valeria Gerloni, Renate Haefner, Clara Malattia, Florence Kanakoudi-Tsakalidou, Susan Nielsen, John Bohnsack, Donna Gibbas, Robert Rennebohm, Olga Voygioyka, Zsolt Balogh, Loredana Lepore, Eva Macejkova, Nico Wulffraat, Sheila Oliveira, Ricardo Russo, A. Buoncompagni, Maria Odete HilárioMaria Giannina Alpigiani, Murray Passo, D. J. Lovell, E. H. Giannini, Rosa Merino, Alberto Martini, Kevin J. Murray, Flavio Sztajnbok, Katerina Jarosova, Chantal Job-Deslandre, Anne Marie Prieur, Frank Dressler, Ivan Foeldvari, Hans Iko Huppertz, Rolf Michael Kuester, Christiana Schauer-Petrowskaja, Polyxeni Pratsidou-Gertsi, Ilonka Orban, Riva Brik, Masha Mukamel, Yosef Uziel, Roberto Barcellona, Fernanda Falcini, Sue Rudge, Ellen Berit Nordal, Marite Rygg, Jose Antonio Melo-Gomes, Julia Garcia Consuegra, Boel Andersson Gare, Traudel Saurenmann, Marie Josephe Sauvain, Seza Ozen, Eileen Baildam, Bram Bernstein, Michael Borzy, Suzanne Bowyer, Gail Cawkwell, Terri Finkel, Brent Graham, Michael Henrickson, Norman Ilowite, Yukiko Kimura, Carol Lindsley, Katherine Madson, Ilona Szer, Richard Vehe, Carol Wallace

Research output: Contribution to journalArticle

30 Scopus citations

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 77% of the patients, side effects of therapy was given as the primary reason for discontinuation. Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)599-605
Number of pages7
JournalClinical and Experimental Rheumatology
Volume24
Issue number5
StatePublished - Sep 2006

Keywords

  • Combination therapy
  • Cyclosporine
  • Cyclosporine A
  • Juvenile chronic arthritis
  • Juvenile idiopathic arthritis
  • Juvenile rheumatoid arthritis
  • Methotrexate

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

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