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16 January 2001 | Volume 134 Issue 2 | Pages 106-114
Background: Corticosteroids remain the cornerstone of therapy for giant-cell arteritis, but relapse during dose tapering and corticosteroid-related adverse events often complicate management of this condition. Although several approaches, including combined therapy with cytotoxic agents, have been suggested to overcome these problems, no study has clearly shown benefits of alternate treatments.
Objective: To analyze the safety and efficacy of combined therapy with corticosteroids and methotrexate in giant-cell arteritis.
Design: Randomized, double-blind, placebo-controlled trial.
Setting: University-based clinic.
Patients: 42 patients with new-onset giant-cell arteritis according to biopsy.
Intervention: High initial doses of corticosteroid were given; the dose was then tapered quickly until therapy was completely withdrawn. Methotrexate or placebo was given weekly from the start of corticosteroid therapy for 24 months.
Measurements: Number of relapses, cumulative dose of corticosteroid, and number of adverse events were assessed on completion of follow-up.
Results: Compared with combined prednisone and placebo therapy, treatment with prednisone and methotrexate reduced the proportion of patients who experienced at least one relapse (45% vs. 84.2%; P = 0.02) and the proportion of patients who experienced multiple relapses (P = 0.004). The mean cumulative dose of prednisone was 4187 ± 1529 mg in the methotrexate group and 5489.5 ± 1396 mg in the placebo group (mean difference, 1302 mg [95% CI, 350 to 2253 mg]; P = 0.009). Overall, the rate and severity of adverse events were similar between groups. Treatment was discontinued in 3 patients in the methotrexate group who experienced definite drug-related adverse events. In sensitivity analysis that included patients lost to follow-up, differences between groups in number of relapses and cumulative dose of prednisone were significant.
Conclusions: Treatment with methotrexate plus corticosteroid is a safe alternative to corticosteroid therapy alone in patients with giant-cell arteritis and is more effective in controlling disease.
Author and Article Information
From Hospital Clínico San Carlos, Madrid, Spain.
Acknowledgments: The authors thank Dr. Isabelle Runkle for helpful comments on the manuscript. They also thank their colleagues in Madrid who referred patients for inclusion in the study.
Grant Support: By grant 93/0739 of the Fondo de Investigación Sanitaria, Spanish Ministry of Health.
Requests for Single Reprints: Juan A. Jover, MD, PhD, Servicio de Reumatología, Hospital Clínico San Carlos, Calle Profesor Martín Lagos s/n, 28040 Madrid, Spain; e-mail, jjover{at}hcsc.insalud.es.
Current Author Addresses: Drs. Jover, Hernández-García, Morado, Bañares, and Fernández-Gutiérrez: Servicio de Reumatología, Hospital Clínico San Carlos, Calle Profesor Martín Lagos s/n, 28040 Madrid, Spain.
Dr. Vargas: Servicio de Farmacología Clínica, Hospital Clínico San Carlos, Calle Profesor Martín Lagos s/n, 28040 Madrid, Spain.
Author Contributions: Conception and design: J.A. Jover, C. Hernández-García, I.C. Morado, A. Bañares, B. Fernández-Gutiérrez.
Analysis and interpretation of the data: J.A. Jover, C. Hernández-García, I.C. Morado, E. Vargas, A. Bañares, B. Fernández-Gutiérrez.
Drafting of the article: J.A. Jover, C. Hernández-García, I.C. Morado, A. Bañares, B. Fernández-Gutiérrez.
Critical revision of the article for important intellectual content: J.A. Jover, C. Hernández-García, E. Vargas, A. Bañares, B. Fernández-Gutiérrez.
Final approval of the article: J.A. Jover, C. Hernández-García, I.C. Morado, E. Vargas, A. Bañares, B. Fernández-Gutiérrez.
Provision of study materials or patients: J.A. Jover, C. Hernández-García, I.C. Morado, B. Fernández-Gutiérrez.
Statistical expertise: E. Vargas.
Obtaining of funding: J.A. Jover, C. Hernández-García, B. Fernández-Gutiérrez.
Collection and assembly of data: C. Hernández-García, I.C. Morado, E. Vargas. ARTICLE
Combined Treatment of Giant-Cell Arteritis with Methotrexate and Prednisone
A Randomized, Double-Blind, Placebo-Controlled Trial
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