Document Detail

An open, randomized comparison study of cyclosporine A, cyclosporine A + methotrexate and cyclosporine A + hydroxychloroquine in the treatment of early severe rheumatoid arthritis.
MedLine Citation:
PMID:  14530867     Owner:  NLM     Status:  MEDLINE    
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.
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
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2003-10-07
Journal Detail:
Title:  Rheumatology international     Volume:  25     ISSN:  0172-8172     ISO Abbreviation:  Rheumatol. Int.     Publication Date:  2005 Jan 
Date Detail:
Created Date:  2005-01-12     Completed Date:  2005-07-05     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8206885     Medline TA:  Rheumatol Int     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  15-22     Citation Subset:  IM    
Unità Operativa di Reumatologia, University Hospital L. Sacco, Via G. B. Grassi 74, 20157 Milan, Italy.
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MeSH Terms
Antirheumatic Agents / therapeutic use*
Arthritis, Rheumatoid / drug therapy*,  pathology,  physiopathology
Cyclosporine / therapeutic use*
Drug Therapy, Combination
Hydroxychloroquine / therapeutic use*
Immunosuppressive Agents / therapeutic use*
Methotrexate / therapeutic use*
Middle Aged
Pain Measurement
Severity of Illness Index
Treatment Outcome
Reg. No./Substance:
0/Antirheumatic Agents; 0/Immunosuppressive Agents; 118-42-3/Hydroxychloroquine; 59-05-2/Methotrexate; 59865-13-3/Cyclosporine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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