Document Detail

A double-blind placebo controlled trial of etanercept in patients with giant cell arteritis and corticosteroid side effects.
MedLine Citation:
PMID:  18086726     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: Open label studies have suggested that tumour necrosis factor (TNF) antagonists led to sustained improvement and corticosteroid sparing effect in patients with giant cell arteritis (GCA). To confirm these observations, we conducted a randomised, double-blind, placebo controlled trial with etanercept in patients with biopsy-proven GCA with side effects secondary to corticosteroids. METHODS: We randomly assigned patients with GCA to receive etanercept (n = 8) or placebo (n = 9) over 1 year together with corticosteroids that were reduced according to a predefined schedule. The primary outcome was the ability to withdraw the corticosteroid therapy and control the disease activity at 12 months. RESULTS: Baseline characteristics were similar in the two groups, although patients in the etanercept group showed higher levels of basal glycaemia (p = 0.02) and a higher erythrocyte sedimentation rate (ESR) (p = 0.01). After 12 months, 50% of the patients in the etanercept group and 22.2% in the placebo group were able to control the disease without corticosteroid therapy (p value not significant). Patients in the etanercept group had a significant lower dose of accumulated prednisone during the first year of treatment (p = 0.03). There were no differences in the number and type of adverse events. CONCLUSION: The limited number of patients included in this study does not allow us to draw definitive conclusions. Etanercept therapy was well tolerated in this aged population. The therapeutic role of etanercept in patients with GCA should be evaluated in studies with a larger number of patients.
V M Martínez-Taboada; V Rodríguez-Valverde; L Carreño; J López-Longo; M Figueroa; J Belzunegui; E M Mola; G Bonilla
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2007-12-17
Journal Detail:
Title:  Annals of the rheumatic diseases     Volume:  67     ISSN:  1468-2060     ISO Abbreviation:  Ann. Rheum. Dis.     Publication Date:  2008 May 
Date Detail:
Created Date:  2008-04-14     Completed Date:  2008-11-14     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372355     Medline TA:  Ann Rheum Dis     Country:  England    
Other Details:
Languages:  eng     Pagination:  625-30     Citation Subset:  IM    
Division of Rheumatology, Hospital Universitario Marqués de Valdecilla, Facultad de Medicina, Universidad de Cantabria, Santander, Spain
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MeSH Terms
Analysis of Variance
Antirheumatic Agents / therapeutic use*
Chi-Square Distribution
Double-Blind Method
Drug Therapy, Combination
Follow-Up Studies
Giant Cell Arteritis / drug therapy*
Immunoglobulin G / therapeutic use*
Immunosuppressive Agents / adverse effects,  therapeutic use
Methylprednisolone / adverse effects,  therapeutic use
Receptors, Tumor Necrosis Factor / therapeutic use*
Sample Size
Treatment Outcome
Tumor Necrosis Factor-alpha / antagonists & inhibitors*
Reg. No./Substance:
0/Antirheumatic Agents; 0/Immunoglobulin G; 0/Immunosuppressive Agents; 0/Receptors, Tumor Necrosis Factor; 0/Tumor Necrosis Factor-alpha; 185243-69-0/TNFR-Fc fusion protein; 83-43-2/Methylprednisolone
Comment In:
Ann Rheum Dis. 2008 May;67(5):577-9   [PMID:  18408108 ]

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

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