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

Piercarlo Sarzi-Puttini, Enzo D'Ingianna, Mario Fumagalli, Magda Scarpellini, Tania Fiorini, Enrico Luigi Chérié-Lignière, Benedetta Panni, Franco Fiorentini, Vincenzo Corbelli, Nebiat Belai Beyene, Claudio Mastaglio, Carlo Severi, Maurizio Locati, Marco Cazzola, Guido Menozzi, Giuseppe Monti, Francesco Saccardo, Giuseppina Alfieri, Fabiola Atzeni

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)15-22
Number of pages8
JournalRheumatology International
Volume25
Issue number1
Publication statusPublished - Jan 2005

ASJC Scopus subject areas

  • Rheumatology

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