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An open, randomized comparison study of cyclosporine A, cyclosporine A + methotrexate and cyclosporine A + hydroxychloroquine in the treatment of early severe rheumatoid arthritis

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Abstract

Purpose

To determine whether a regimen of cyclosporine (CSA) and methotrexate (MTX), or CSA and hydroxychloroquine (HCQ) introduced in early rheumatoid arthritis (RA) can produce a significant improvement in clinical outcome and/or retard radiographic damage in comparison with standard monotherapy with CSA alone.

Methods

One hundred five patients with active RA of less than 36 months duration, who had never previously been treated with immunosuppressive agents, were included in a 12-month, multi-center, open, randomized trial. Patients who fulfilled the criteria for early severe RA were randomized to receive either combination therapy (CSA+MTX n=34, CSA+HCQ n=35) or CSA alone (n=36).

Results

CSA+MTX was more effective than the other two treatment groups in controlling RA symptoms. CSA+MTX did not show a significant radiographic progression according to Larsen–Dale (0.90±3.89 compared to baseline values, P>0.05); moreover, patients treated with CSA alone or CSA+HCQ showed a significant worsening of Larsen–Dale score (2.91±5.99 and 2.97±4.28 respectively vs baseline values, P<0.05), although not significant when compared with the CSA+HCQ group (P=0.56 and 0.39, respectively).

Conclusions

This trial indicated that CSA+MTX was more effective than the other two treatments in improving clinical data and inhibiting radiographic progression, although the differences were not significant in this relatively small study. However, the difference was significant in favor of CSA+MTX regarding ACR 50% response.

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Authors and Affiliations

  1. Unità Operativa di Reumatologia, University Hospital L. Sacco, Via G. B. Grassi 74, 20157 , Milan, Italy

    Piercarlo Sarzi-Puttini, Tania Fiorini, Benedetta Panni & Fabiola Atzeni

  2. Unità Operativa di Reumatologia-Medicina Interna, Azienda Ospedaliera Sant’Anna, Como, Italy

    Enzo D’Ingianna, Franco Fiorentini, Vincenzo Corbelli & Giuseppina Alfieri

  3. Divisione di Medicina Riabilitativa, Istituti clinici di Perfezionamento, Milan, Italy

    Mario Fumagalli

  4. Unità Operativa di Reumatologia-Medicina Interna, Ospedale Busto Arsizio, Busto Arsizio, Italy

    Magda Scarpellini

  5. Unità Operativa di Medicina Interna, Ospedale Bassini, Cinisello Balsamo, Italy

    Enrico Luigi Chérié-Lignière & Nebiat Belai Beyene

  6. Unità Operativa di Riabilitazione e Reumatologia, Ospedale di Gravedona, Gravedona, Italy

    Claudio Mastaglio & Carlo Severi

  7. Unità Operativa di Riabilitazione, Ospedale di Saronno, Saronno, Italy

    Maurizio Locati & Marco Cazzola

  8. Unità Operativa di Medicina Interna, Ospedale di Sondrio, Sondrio, Italy

    Guido Menozzi

  9. Unità Operativa di Medicina Interna e Reumatologia, Ospedale di Saronno, Saronno, Italy

    Giuseppe Monti & Francesco Saccardo

Authors
  1. Piercarlo Sarzi-Puttini
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  2. Enzo D’Ingianna
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  7. Benedetta Panni
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  8. Franco Fiorentini
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  11. Claudio Mastaglio
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  12. Carlo Severi
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  16. Giuseppe Monti
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Correspondence to Piercarlo Sarzi-Puttini.

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Sarzi-Puttini, P., D’Ingianna, E., Fumagalli, M. et al. An open, randomized comparison study of cyclosporine A, cyclosporine A + methotrexate and cyclosporine A + hydroxychloroquine in the treatment of early severe rheumatoid arthritis. Rheumatol Int 25, 15–22 (2005). https://doi.org/10.1007/s00296-003-0384-2

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  • DOI: https://doi.org/10.1007/s00296-003-0384-2

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