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

Victor M Martinez Taboada ¹, Vicente Rodríguez-Valverde ^2*, Luis Carreño ³, Javier Lopez-Longo ³, Manuel Figueroa ⁴, Joaquín Belzunegui ⁴, Emilio Martín-Mola ⁵ and Gema Bonilla ⁵

¹ Hospital Universitario Marques de Valdecilla. Facultad de Medicina. Universidad de Cantabria, Spain
² Facultad de Medicina. Universidad de Cantabria, Spain
³ Hospital Universitario Gregorio Marañón, Spain
⁴ Hospital de Donosti, Spain
⁵ Hospital Universitario La Paz, Spain

^* To whom correspondence should be addressed. E-mail: rodriguv{at}unican.es.

Accepted 2 December 2007

Abstract

Objective: Open label studies have suggested that TNF antagonists led to sustained improvement and corticosteroid sparing effect in patients with giant cell arteritis (GCA). To confirm these observations, we conducted a randomized, double-blind, placebo controlled trial with etanercept in patients with biopsy-proven GCA with side-effects secondary to corticosteroids.

Methods: We randomly assigned GCA patients to receive etanercept (n=8) or placebo (n=9) during 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 controlling the disease activity at 12 months.

Results: Baseline characteristics were similar in the 2 groups although patients in the etanercept group showed higher levels of basal glycemia (p=0.02) and a higher 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=NS). 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 to draw definitive conclusions. Etanercept therapy was well tolerated in this aged population. The therapeutic role of etanercept in GCA patients should be evaluated in studies with a larger number of patients.

Keywords: corticosteroids, etanercept, giant cell arteritis, side effects

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