Document Detail

Step-down approach using either cyclosporin A or methotrexate as maintenance therapy in early rheumatoid arthritis.
MedLine Citation:
PMID:  11932879     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To evaluate the feasibility and outcome of the step-down approach using either cyclosporin A (CSA) or methotrexate (MTX) as maintenance therapy following 6 months treatment with these 2 agents in combination in early, nonerosive rheumatoid arthritis (RA). METHODS: Fifty-seven patients younger than 65 years with early, nonerosive RA were first treated with CSA and MTX in combination for 6 months. They were then randomly stepped down to single-agent maintenance treatment for another 18 months. Safety, clinical efficacy, survival on treatment, and radiographic progression were evaluated. RESULTS: When being treated with combination therapy, 7 of the 57 patients (12.3%) withdrew because of adverse events. Of the remaining 50 patients, 42 (84.0%) were American College of Rheumatology (ACR) 20% responders, 30 (60.0%) were ACR 50% responders, and 23 (46.0%) were ACR 70% responders. At month 6, 22 patients were randomized to CSA and 27 to MTX. During this trial period, the treatment was discontinued by 16 patients taking CSA (mainly because of loss of efficacy) and by 4 taking MTX. At month 24, the probability (+/- SEM) of survival on treatment was 0.273 +/- 0.09 for CSA and 0.852 +/- 0.07 for MTX. Of the 6 CSA patients who completed the trial, 4 (66.7%) were ACR 20% responders, and 3 (50%) were both ACR 50% and ACR 70% responders. Of the 23 completers in the MTX arm, 21 (91.3%) were ACR 20% responders, 18 (78.3%) were ACR 50%, and 10 (43.5%) were ACR 70% responders. The treatment was not responsible for severe adverse events. Radiography showed a slow progression in the damage score and number of eroded joints in both treatment groups. CONCLUSION: Stepping down to single agent maintenance therapy following 6 months of combination treatment with CSA and MTX in early RA was only successful with MTX. Because this treatment did not prevent some radiographic progression, other approaches (e.g., step-up approach) may be more appropriate in early RA.
Antonio Marchesoni; Norma Battafarano; Marco Arreghini; Raffaele Pellerito; Maria Cagnoli; Porziana Prudente; Alfonso Cerase; Francesco Priolo; Sergio Tosi
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Arthritis and rheumatism     Volume:  47     ISSN:  0004-3591     ISO Abbreviation:  Arthritis Rheum.     Publication Date:  2002 Feb 
Date Detail:
Created Date:  2002-04-04     Completed Date:  2002-04-18     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0370605     Medline TA:  Arthritis Rheum     Country:  United States    
Other Details:
Languages:  eng     Pagination:  59-66     Citation Subset:  AIM; IM    
G. Pini Orthopaedic Institute, Milan, Italy.
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MeSH Terms
Antirheumatic Agents / administration & dosage*
Arthritis, Rheumatoid / drug therapy*
Cyclosporine / administration & dosage*
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Therapy, Combination
Feasibility Studies
Joints / pathology,  physiopathology
Methotrexate / administration & dosage*
Middle Aged
Reg. No./Substance:
0/Antirheumatic Agents; 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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