Document Detail


Aggressive combination therapy with intra-articular glucocorticoid injections and conventional disease-modifying anti-rheumatic drugs in early rheumatoid arthritis: second-year clinical and radiographic results from the CIMESTRA study.
MedLine Citation:
PMID:  17878209     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To investigate whether clinical and radiographic disease control can be achieved and maintained in patients with early, active rheumatoid arthritis (RA) during the second year of aggressive treatment with conventional disease-modifying antirheumatic drugs (DMARDs) and intra-articular corticosteroid. This paper presents the results of the second year of the randomised, controlled double-blind CIMESTRA (Ciclosporine, Methotrexate, Steroid in RA) study. METHODS: 160 patients with early RA (duration <6 months) were randomised to receive intra-articular betamethasone in any swollen joint in combination with step-up treatment with either methotrexate and placebo-ciclosporine (monotherapy) or methotrexate plus ciclosporine (combination therapy) during the first 76 weeks. At week 68 hydroxychlorochine 200 mg daily was added. From week 76-104 ciclosporine/placebo-ciclosporine was tapered to zero. RESULTS: American College of Rheumatology 20% improvement (ACR20), ACR50 and ACR70 levels were achieved in 88%, 79% and 59% of patients in the combination vs 72%, 62% and 54% in the monotherapy group (p = 0.03, 0.02 and 0.6 between groups). The patients globally declined from 50 to 12 vs 52 to 9, with 51% and 50% in Disease Activity Score (DAS) remission, respectively. Mean (SD) progressions in total Sharp-van der Heijde scores were 1.42 (3.52) and 2.03 (5.86) in combination and monotherapy groups, respectively (not significant). Serum creatinine levels increased by 7% in the combination group (4% in monotherapy), but hypertension was not more prevalent. CONCLUSION: Continuous methotrexate and intra-articular corticosteroid treatment resulted in excellent clinical response and disease control at 2 years, and the radiographic erosive progression was minimal. Addition of ciclosporine during the first 76 weeks resulted in significantly better ACR20 and ACR50 responses, but did not have any additional effect on remission rate and radiographic outcome.
Authors:
M L Hetland; K Stengaard-Pedersen; P Junker; T Lottenburger; I Hansen; L S Andersen; U Tarp; A Svendsen; J K Pedersen; H Skjødt; U B Lauridsen; T Ellingsen; G V O Hansen; H Lindegaard; A Vestergaard; A G Jurik; M Østergaard; K Hørslev-Petersen;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2007-09-18
Journal Detail:
Title:  Annals of the rheumatic diseases     Volume:  67     ISSN:  1468-2060     ISO Abbreviation:  Ann. Rheum. Dis.     Publication Date:  2008 Jun 
Date Detail:
Created Date:  2008-05-13     Completed Date:  2008-06-20     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372355     Medline TA:  Ann Rheum Dis     Country:  England    
Other Details:
Languages:  eng     Pagination:  815-22     Citation Subset:  IM    
Affiliation:
Department of Rheumatology, Copenhagen University Hospital, Hvidovre, Denmark.
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Antirheumatic Agents / therapeutic use*
Arthritis, Rheumatoid / drug therapy*,  radiography
Arthrography
Betamethasone / administration & dosage
Combined Modality Therapy
Cyclosporine / therapeutic use
Disease Progression
Drug Therapy, Combination
Female
Glucocorticoids / therapeutic use*
Humans
Hydroxychloroquine / therapeutic use
Immunosuppressive Agents / therapeutic use*
Injections, Intra-Articular
Male
Methotrexate / therapeutic use
Middle Aged
Severity of Illness Index
Statistics, Nonparametric
Treatment Outcome
Chemical
Reg. No./Substance:
0/Antirheumatic Agents; 0/Glucocorticoids; 0/Immunosuppressive Agents; 118-42-3/Hydroxychloroquine; 378-44-9/Betamethasone; 59-05-2/Methotrexate; 59865-13-3/Cyclosporine
Investigator
Investigator/Affiliation:
T Lorenzen / ; S H Jensen / ; J Pødenphant / ; H Bendtsen / ; K L Faarvang / ; M S Hansen / ; T M Hansen / ; H Nielsen / ; S Jacobsen / ; O Majgaard / ; J Beier / ; L Ejstrup / ; J B Knudsen / ; H Laustrup / ; N S Krogh / ; Ap S Zitelab / ; J Vallø / ; H S Thomsen / ; B Ejbjerg / ; T Torfing / ; G Bukh / ; J Frederiksen / ; P Rasmussen / ; K Theilgård / ; L Gerdes / ; H Holm / ; K B Lorentzen / ; B Pedersen-Zbinden /

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


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