Roberto Caporali, MD; Marco A. Cimmino, MD; Gianfranco Ferraccioli, MD; Roberto Gerli, MD; Catherine Klersy, MD; Carlo Salvarani, MD; Carlomaurizio Montecucco, MD; for the Systemic Vasculitis Study Group of the Italian Society for Rheumatology
Note: Drs. Caporali and Cimmino contributed equally to the manuscript.
Acknowledgments: The authors thank Franco Barattini, Opera Contract Research Organization, for supporting the trial; Vanni Bascapè, Pharmacology Department at Policlinico San Matteo, for manufacturing the placebos; and Carlo Pesce, MD, PhD, for reviewing the manuscript.
Grant Support: By Società Italiana di Reumatologia and IRCCS Policlinico San Matteo.
Potential Financial Conflicts of Interest: None disclosed.
Requests for Single Reprints: Roberto Caporali, MD, Divisione di Reumatologia, Policlinico San Matteo, Piazzale Golgi 2, 27100 Pavia, Italy; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Caporali and Montecucco: IRCCS Policlinico San Matteo, Piazzale Golgi 2, 27100 Pavia, Italy.
Dr. Cimmino: Department of Internal Medicine, Viale Benedetto XV, 16100 Genova, Italy.
Dr. Ferraccioli: Division of Rheumatology, School of Medicine, Catholic University of the Sacred Heart—CIC, Via Moscati 31, 00168 Rome, Italy.
Dr. Gerli: 1st Medicina Interna e Scienze Oncologiche, Policlinico Monteluce, 06122 Perugia, Italy.
Dr. Klersy: Direzione Scientifica, IRCCS Policlinico San Matteo, Piazzale Golgi 2, 27100 Pavia, Italy.
Dr. Salvarani: Azienda Ospedaliera, Via Umberto I 50, 42100 Reggio Emilia, Italy.
Author Contributions Conception and design: R. Caporali, M.A. Cimmino, G. Ferraccioli, R. Gerli, C. Salvarani, C. Montecucco.
Analysis and interpretation of the data: R. Caporali, M.A. Cimmino, G. Ferraccioli, R. Gerli, C. Klersy, C. Salvarani, C. Montecucco.
Drafting of the article: R. Caporali, M.A. Cimmino, C. Montecucco.
Critical revision of the article for important intellectual content: R. Caporali, M.A. Cimmino, G. Ferraccioli, R. Gerli, C. Salvarani, C. Montecucco.
Final approval of the article: R. Caporali, M.A. Cimmino, G. Ferraccioli, R. Gerli, C. Klersy, C. Salvarani, C. Montecucco.
Provision of study materials or patients: R. Caporali, M.A. Cimmino, G. Ferraccioli, R. Gerli, C. Salvarani, C. Montecucco.
Statistical expertise: C. Klersy.
Obtaining of funding: R. Caporali, C. Montecucco.
Collection and assembly of data: R. Caporali, C. Klersy, C. Montecucco.
Steroids are the standard treatment for polymyalgia rheumatica. The efficacy of the candidate drug methotrexate has not yet been demonstrated in controlled studies.
To compare the efficacy and safety of prednisone plus methotrexate and prednisone alone in patients with polymyalgia rheumatica.
Multicenter randomized, double-blind, placebo-controlled trial.
5 Italian rheumatology clinics.
72 patients with newly diagnosed polymyalgia rheumatica.
The proportion of patients no longer taking prednisone, the number of flare-ups, and the cumulative prednisone dose after 76 weeks.
Prednisone dosage (25 mg/d) was tapered to 0 mg/d within 24 weeks and was adjusted if flare-ups occurred. Oral methotrexate (10 mg) or placebo, with folinic acid supplementation (7.5 mg), was given weekly for 48 weeks.
Twenty-eight of 32 patients in the methotrexate group and 16 of 30 patients in the placebo group were no longer taking prednisone at 76 weeks (P = 0.003). The risk difference was 34 percentage points (95% CI, 11 to 53 percentage points). Similar results were obtained after adjustment for C-reactive protein level and duration of symptoms in a multivariate model. Fifteen of 32 patients in the methotrexate group and 22 of 30 patients in the placebo group had at least 1 flare-up by the end of follow-up (P = 0.04). The median prednisone dose was 2.1 g in the methotrexate group and 2.97 g in the placebo group (P = 0.03). The rate and severity of adverse events were similar.
Follow-up was short, and a high dose of folinic acid and a relatively high starting dosage of prednisone were used. Ten of 72 patients (14%) discontinued treatment or were lost to follow-up.
Prednisone plus methotrexate is associated with shorter prednisone treatment and steroid sparing. It may be useful in patients at high risk for steroid-related toxicity.
Roberto Caporali, Marco A. Cimmino, Gianfranco Ferraccioli, Roberto Gerli, Catherine Klersy, Carlo Salvarani, et al. Prednisone plus Methotrexate for Polymyalgia Rheumatica: A Randomized, Double-Blind, Placebo-Controlled Trial. Ann Intern Med. 2004;141:493–500. doi: 10.7326/0003-4819-141-7-200410050-00005
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Published: Ann Intern Med. 2004;141(7):493-500.
Endocrine and Metabolism, Giant Cell Arteritis/Polymyalgia Rheumatica, Rheumatology.
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