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Ann Rheum Dis 2008;67:625-630 doi:10.1136/ard.2007.082115
  • Extended report

A double-blind placebo controlled trial of etanercept in patients with giant cell arteritis and corticosteroid side effects

  1. V M Martínez-Taboada1,
  2. V Rodríguez-Valverde1,
  3. L Carreño2,
  4. J López-Longo2,
  5. M Figueroa3,
  6. J Belzunegui3,
  7. E M Mola4,
  8. G Bonilla4
  1. 1
    Division of Rheumatology Hospital Universitario Marqués de Valdecilla. Facultad de Medicina, Universidad de Cantabria, Santander, Spain
  2. 2
    Hospital Universitario Gregorio Marañón, Madrid, Spain
  3. 3
    Hospital de Donosti, San Sebastían, Guipuzcoa, Spain
  4. 4
    Hospital Universitario La Paz, Madrid, Spain
  1. V Rodriguez-Valverde, Facultad de Medicina, Universidad de Cantabria, Rheumatology Division, Hospital Universitario “Marqués de Valdecilla”, Avda. Valdecilla s/n 39008, Santander, Spain; rodriguv{at}unican.es
  • Accepted 2 December 2007
  • Published Online First 17 December 2007

Abstract

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.

Footnotes

  • Competing interests: VMMT has received grants for research aid from Wyeth Pharma and Schering-Plough. VRV has received a fee for speaking, LC has received fees for speaking and consulting, and EMM has received fees for speaking and consulting from Wyeth Pharma.

  • Ethics approval: The study was approved by the institutional review board and the ethics committee at each study centre.

  • Patient consent: All patients gave written informed consent.

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