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 Hilário & 47 others Maria 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 Todd Ilowite, Yukiko Kimura, Carol Lindsley, Katherine Madson, Ilona Szer, Richard Vehe, Carol Wallace

Research output: Contribution to journalArticle

30 Citations (Scopus)

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
Externally publishedYes

Fingerprint

Juvenile Arthritis
Rheumatology
Marketing
Cyclosporine
Pediatrics
Controlled Clinical Trials
Therapeutic Uses
Ambulatory Care
Prednisone
Therapeutics
Safety

Keywords

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

ASJC Scopus subject areas

  • Rheumatology
  • Immunology

Cite this

Ruperto, N., Ravelli, A., Castell, E., Gerloni, V., Haefner, R., Malattia, C., ... Wallace, C. (2006). Cyclosporine A in juvenile idiopathic arthritis. Results of the PRCSG/PRINTO phase IV post marketing surveillance study. Clinical and Experimental Rheumatology, 24(5), 599-605.

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

In: Clinical and Experimental Rheumatology, Vol. 24, No. 5, 09.2006, p. 599-605.

Research output: Contribution to journalArticle

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, MO, Alpigiani, MG, Passo, M, Lovell, DJ, Giannini, EH, Merino, R, Martini, A, Murray, KJ, Sztajnbok, F, Jarosova, K, Job-Deslandre, C, Prieur, AM, Dressler, F, Foeldvari, I, Huppertz, HI, Kuester, RM, Schauer-Petrowskaja, C, Pratsidou-Gertsi, P, Orban, I, Brik, R, Mukamel, M, Uziel, Y, Barcellona, R, Falcini, F, Rudge, S, Nordal, EB, Rygg, M, Melo-Gomes, JA, Consuegra, JG, Gare, BA, Saurenmann, T, Sauvain, MJ, Ozen, S, Baildam, E, Bernstein, B, Borzy, M, Bowyer, S, Cawkwell, G, Finkel, T, Graham, B, Henrickson, M, Ilowite, NT, Kimura, Y, Lindsley, C, Madson, K, Szer, I, Vehe, R & Wallace, C 2006, 'Cyclosporine A in juvenile idiopathic arthritis. Results of the PRCSG/PRINTO phase IV post marketing surveillance study', Clinical and Experimental Rheumatology, vol. 24, no. 5, pp. 599-605.
Ruperto, Nicolino ; Ravelli, Angelo ; Castell, E. ; Gerloni, Valeria ; Haefner, Renate ; Malattia, Clara ; Kanakoudi-Tsakalidou, Florence ; Nielsen, Susan ; Bohnsack, John ; Gibbas, Donna ; Rennebohm, Robert ; Voygioyka, Olga ; Balogh, Zsolt ; Lepore, Loredana ; Macejkova, Eva ; Wulffraat, Nico ; Oliveira, Sheila ; Russo, Ricardo ; Buoncompagni, A. ; Hilário, Maria Odete ; Alpigiani, Maria Giannina ; Passo, Murray ; Lovell, D. J. ; Giannini, E. H. ; Merino, Rosa ; Martini, Alberto ; Murray, Kevin J. ; Sztajnbok, Flavio ; Jarosova, Katerina ; Job-Deslandre, Chantal ; Prieur, Anne Marie ; Dressler, Frank ; Foeldvari, Ivan ; Huppertz, Hans Iko ; Kuester, Rolf Michael ; Schauer-Petrowskaja, Christiana ; Pratsidou-Gertsi, Polyxeni ; Orban, Ilonka ; Brik, Riva ; Mukamel, Masha ; Uziel, Yosef ; Barcellona, Roberto ; Falcini, Fernanda ; Rudge, Sue ; Nordal, Ellen Berit ; Rygg, Marite ; Melo-Gomes, Jose Antonio ; Consuegra, Julia Garcia ; Gare, Boel Andersson ; Saurenmann, Traudel ; Sauvain, Marie Josephe ; Ozen, Seza ; Baildam, Eileen ; Bernstein, Bram ; Borzy, Michael ; Bowyer, Suzanne ; Cawkwell, Gail ; Finkel, Terri ; Graham, Brent ; Henrickson, Michael ; Ilowite, Norman Todd ; Kimura, Yukiko ; Lindsley, Carol ; Madson, Katherine ; Szer, Ilona ; Vehe, Richard ; Wallace, Carol. / Cyclosporine A in juvenile idiopathic arthritis. Results of the PRCSG/PRINTO phase IV post marketing surveillance study. In: Clinical and Experimental Rheumatology. 2006 ; Vol. 24, No. 5. pp. 599-605.
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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.",
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TY - JOUR

T1 - Cyclosporine A in juvenile idiopathic arthritis. Results of the PRCSG/PRINTO phase IV post marketing surveillance study

AU - Ruperto, Nicolino

AU - Ravelli, Angelo

AU - Castell, E.

AU - Gerloni, Valeria

AU - Haefner, Renate

AU - Malattia, Clara

AU - Kanakoudi-Tsakalidou, Florence

AU - Nielsen, Susan

AU - Bohnsack, John

AU - Gibbas, Donna

AU - Rennebohm, Robert

AU - Voygioyka, Olga

AU - Balogh, Zsolt

AU - Lepore, Loredana

AU - Macejkova, Eva

AU - Wulffraat, Nico

AU - Oliveira, Sheila

AU - Russo, Ricardo

AU - Buoncompagni, A.

AU - Hilário, Maria Odete

AU - Alpigiani, Maria Giannina

AU - Passo, Murray

AU - Lovell, D. J.

AU - Giannini, E. H.

AU - Merino, Rosa

AU - Martini, Alberto

AU - Murray, Kevin J.

AU - Sztajnbok, Flavio

AU - Jarosova, Katerina

AU - Job-Deslandre, Chantal

AU - Prieur, Anne Marie

AU - Dressler, Frank

AU - Foeldvari, Ivan

AU - Huppertz, Hans Iko

AU - Kuester, Rolf Michael

AU - Schauer-Petrowskaja, Christiana

AU - Pratsidou-Gertsi, Polyxeni

AU - Orban, Ilonka

AU - Brik, Riva

AU - Mukamel, Masha

AU - Uziel, Yosef

AU - Barcellona, Roberto

AU - Falcini, Fernanda

AU - Rudge, Sue

AU - Nordal, Ellen Berit

AU - Rygg, Marite

AU - Melo-Gomes, Jose Antonio

AU - Consuegra, Julia Garcia

AU - Gare, Boel Andersson

AU - Saurenmann, Traudel

AU - Sauvain, Marie Josephe

AU - Ozen, Seza

AU - Baildam, Eileen

AU - Bernstein, Bram

AU - Borzy, Michael

AU - Bowyer, Suzanne

AU - Cawkwell, Gail

AU - Finkel, Terri

AU - Graham, Brent

AU - Henrickson, Michael

AU - Ilowite, Norman Todd

AU - Kimura, Yukiko

AU - Lindsley, Carol

AU - Madson, Katherine

AU - Szer, Ilona

AU - Vehe, Richard

AU - Wallace, Carol

PY - 2006/9

Y1 - 2006/9

N2 - 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.

AB - 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.

KW - Combination therapy

KW - Cyclosporine

KW - Cyclosporine A

KW - Juvenile chronic arthritis

KW - Juvenile idiopathic arthritis

KW - Juvenile rheumatoid arthritis

KW - Methotrexate

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