Document Detail

Radiographic progression in early rheumatoid arthritis: a 12-month randomized controlled study comparing the combination of cyclosporin and methotrexate with methotrexate alone.
MedLine Citation:
PMID:  12810924     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To determine whether patients with early rheumatoid arthritis (RA) treated with cyclosporin A (CsA) and methotrexate (MTX) in combination for 12 months show a lower rate of radiographic deterioration than those treated with MTX alone. METHODS: In this controlled and randomized single-blind trial, 61 consecutive patients with untreated RA of less than 2 yr duration were treated with either CsA + MTX combination therapy (n = 30) or MTX alone (n = 31). The primary end-point was radiographic progression after 12 months, measured using the damage score (DS) of the Sharp and van der Heijde method. RESULTS: Although there was a significant difference between the mean baseline and 12-month DS in both treatment groups (MTX/CsA, 1.93 +/- 0.90; MTX, 7.47 +/- 2.03), it was significantly less in the combination arm (P = 0.018). Of the 30 evaluable CsA + MTX patients, 16 (53%) were ACR20 responders, 15 (50%) ACR50 and 14 (47%) ACR70; the corresponding figures in the MTX arm were 19 (61%), 13 (44%) and 6 (19%). Toxicity was acceptable in both groups. CONCLUSIONS: In patients with early RA, CsA + MTX combination therapy led to a significantly lower rate of 12-month radiographic progression, was effective on inflammatory articular symptoms, and was well tolerated.
A Marchesoni; N Battafarano; M Arreghini; B Panni; M Gallazzi; S Tosi
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial     Date:  2003-06-16
Journal Detail:
Title:  Rheumatology (Oxford, England)     Volume:  42     ISSN:  1462-0324     ISO Abbreviation:  Rheumatology (Oxford)     Publication Date:  2003 Dec 
Date Detail:
Created Date:  2003-12-03     Completed Date:  2004-01-23     Revised Date:  2007-09-06    
Medline Journal Info:
Nlm Unique ID:  100883501     Medline TA:  Rheumatology (Oxford)     Country:  England    
Other Details:
Languages:  eng     Pagination:  1545-9     Citation Subset:  AIM; IM    
Rheumatology Department, University of Milan, Italy.
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MeSH Terms
Antirheumatic Agents / adverse effects,  therapeutic use*
Arthritis, Rheumatoid / drug therapy*,  radiography
Cyclosporine / adverse effects,  therapeutic use*
Disease Progression
Drug Therapy, Combination
Immunosuppressive Agents / adverse effects,  therapeutic use*
Methotrexate / adverse effects,  therapeutic use*
Middle Aged
Single-Blind Method
Treatment Outcome
Reg. No./Substance:
0/Antirheumatic Agents; 0/Immunosuppressive 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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