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Combined Treatment of Giant-Cell Arteritis with Methotrexate and Prednisone: A Randomized, Double-Blind, Placebo-Controlled Trial

Juan A. Jover, MD, PhD; César Hernández-García, MD, PhD; Inmaculada C. Morado, MD; Emilio Vargas, MD, PhD; Antonio Bañares, MD, PhD; and Benjamín Fernández-Gutiérrez, MD, PhD
[+] Article and Author 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@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.


Ann Intern Med. 2001;134(2):106-114. doi:10.7326/0003-4819-134-2-200101160-00010
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Giant-cell (temporal) arteritis is a T-cell–dependent vasculitis in elderly persons that involves large and medium-sized arteries (1). Treatment with high doses of corticosteroids usually suppresses inflammatory activity dramatically, thus improving clinical symptoms and preventing disease-related complications. It is commonly accepted that patients should receive prednisone at an initial dosage of 40 to 60 mg/d, with subsequent tapering to a lower maintenance dose that is given for an average of 2 years (2). However, up to 60% of patients experience disease relapse during corticosteroid tapering (34), and long-term corticosteroid therapy leads to corticosteroid-related adverse events in up to 80% of patients (57). Corticosteroid-related side effects are thus a major problem in the management of giant-cell arteritis in already frail patients.

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Figures

Grahic Jump Location
Figure 1.
Flow of participants through the study.
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Grahic Jump Location
Figure 2.
Median cumulative dose of prednisone in the methotrexate group (solid line) and placebo group (dotted line).
Grahic Jump Location

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Summary for Patients

Combining Methotrexate with Prednisone To Treat Temporal Arteritis

The summary below is from the full report titled “Combined Treatment of Giant-Cell Arteritis with Methotrexate and Prednisone. A Randomized, Double-Blind, Placebo-Controlled Trial.” It is in the 16 January 2001 issue of Annals of Internal Medicine (volume 134, pages 106-114). The authors are JA Jover, C Hernández-García, IC Morado, E Vargas, A Bañares, and B Fernández-Gutiérrez.

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