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Infliximab plus Prednisone or Placebo plus Prednisone for the Initial Treatment of Polymyalgia Rheumatica: A Randomized Trial

Carlo Salvarani, MD; PierLuigi Macchioni, MD; Carlo Manzini, MD; Giuseppe Paolazzi, MD; Aldo Trotta, MD; Paolo Manganelli, MD; Marco Cimmino, MD; Roberto Gerli, MD; Maria Grazia Catanoso, MD; Luigi Boiardi, MD; Fabrizio Cantini, MD; Catherine Klersy, MD; and Gene G. Hunder, MD
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From the Arcispedale S. Maria Nuova, Reggio Emilia, Italy; Policlinico di Modena, Modena, Italy; Ospedale S. Chiara, Trent, Italy; Policlinico S. Salvatore, L'Aquila, Italy; Ospedale Maggiore, Parma, Italy; Università di Genova, Genoa, Italy; Università di Perugia, Perugia, Italy; Ospedale di Prato, Prato, Italy; Istituto di Ricovero e Cura a Carattere Scientifico, Fondazione Policlinico San Matteo, Pavia, Italy; and Mayo Clinic, Rochester, Minnesota.

Acknowledgment: The authors thank Giuseppe Germanò, MD, at the Arcispedale S. Maria Nuova, Reggio Emilia, Italy, for help in recruiting patients.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Carlo Salvarani, MD, Servizio di Reumatologia, Arcispedale S. Maria Nuova, Viale Risorgimento N 80, 42100 Reggio Emilia, Italy; e-mail, salvarani.carlo@asmn.re.it.

Current Author Addresses: Drs. Salvarani, Macchioni, Catanoso, and Boiardi: Arcispedale S. Maria Nuova, Viale Risorgimento N 80, 42100 Reggio Emilia, Italy.

Dr. Manzini: Policlinico di Modena, Via del Pozzo N 71, 41100 Modena, Italy.

Dr. Paolazzi: Ospedale S. Chiara, Largo Medaglie d'Oro N 9, 38100 Trent, Italy.

Dr. Trotta: Policlinico S. Salvatore, Via Vetoio, Coppito, 67100 L'Aquila, Italy.

Dr. Manganelli: Ospedale Maggiore, Via Gramsci N 14, 43100 Parma, Italy.

Dr. Cimmino: Ospedale S. Martino, Viale Benedetto XV N 6, 16132 Genoa, Italy.

Dr. Gerli: Policlinico Monteluce, Via Brunamonti, 06122 Perugia, Italy.

Dr. Cantini: Ospedale di Prato, Piazza Ospedale N 1, 59100 Prato, Italy.

Dr. Klersy: Policlinico S. Matteo, Piazzale Golgi 2, 27100 Pavia, Italy.

Dr. Hunder: Mayo School of Medicine, Mayo Clinic, 200 First Street, SW, Rochester, MN 55905.

Author Contributions: Conception and design: C. Salvarani, P.L. Macchioni, M.G. Catanoso, L. Boiardi, F. Cantini, G.G. Hunder.

Analysis and interpretation of the data: C. Salvarani.

Drafting of the article: C. Salvarani.

Critical revision of the article for important intellectual content: P.L. Macchioni, M. Cimmino, L. Boiardi, G.G. Hunder.

Final approval of the article: C. Salvarani, P.L. Macchioni, C. Manzini, G. Paolazzi, A. Trotta, P. Manganelli, M. Cimmino, R. Gerli, M.G. Catanoso, L. Boiardi, F. Cantini, C. Klersy, G.G. Hunder.

Provision of study materials or patients: P.L. Macchioni, C. Manzini, G. Paolazzi, A. Trotta, P. Manganelli, M. Cimmino, R. Gerli, M.G. Catanoso.

Statistical expertise: C. Klersy.

Collection and assembly of data: C. Salvarani, P.L. Macchioni, L. Boiardi.

Ann Intern Med. 2007;146(9):631-639. doi:10.7326/0003-4819-146-9-200705010-00005
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The results of our randomized, double-blind, placebo-controlled study suggest that adding infliximab to prednisone does not substantially affect the course of polymyalgia rheumatica when the effect is defined as the proportion of patients without relapse or recurrence through the first 52 weeks of therapy. The confidence intervals encompass a range of possible true effects, from benefit to harm. Results of our sensitivity analysis supported our main analysis. Similarly, the 2 groups did not differ in the proportion of patients no longer taking prednisone, the numbers of relapses and recurrences, the duration of prednisone treatment, and the cumulative prednisone dose.

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Grahic Jump Location
Figure 2.
Flare-free survival.

The cumulative probability of not having relapse or recurrence over time did not statistically differ between the groups (P = 0.53, Cox regression stratified by study center). IFX = infliximab.

Grahic Jump Location




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Submit a Comment/Letter
Polymyalgia Rheumatica and Giant Cell Arteritis: First of All, Early Diagnosis!
Posted on May 7, 2007
Sergio Stagnaro
Biophysical Semeiotics Research Laboratory
Conflict of Interest: None Declared

Sirs, as regards the intriguing and fascinating C. Salvarani's et al. article, I agree with its frank conclusion. In addition, as concerns such as rheumatic disorder, a long well-established clinical experience (2-4) allows me to state that first of all we need early bedside diagnosis of both Polymyalgya Rheumatica and most frequently associated Gyant Cell Arteritis (2-4). In my opinion, diagnosing them "two wekks" after their beginn is too later! As a matter of fact, I noticed that cortisone therapy was more successfull, when promptly administered to patients diagnosed in early stage of disorder, recognised clinically with the aid of Biophysical Semeiotics (2-5). Finally, considering the "Variant" Benign Acute Polymyalgya Rheumatica, I described formerly exckusively in individuals, most frequently female, under 60 year-age, involved always by Rheumatic Constitution, conditio sine qua non of disorders, rheumatic in origin (6),soon after flu episode (2, 3), the best therapy proved to be anti-body synthesis stimulation with oral bacterial vaxines.


1) Carlo Salvarani, PierLuigi Macchioni, Carlo Manzini,et al.Infliximab plus Prednisone or Placebo plus Prednisone for the Initial Treatment of Polymyalgia Rheumatica: A Randomized Trial. Ann Intern Med 2007; 146: 631 -639.

2)Stagnaro S., Auscultatory Percussion of Rheumatic Diseases. X European Congress of Rheumatology. Moscow. 26 June-July, Proceedings, pg 175. 1983

3) Stagnaro S., Auscultatory Percussion Therapeutic Monitoring and Cerebral Dominance in Rheumatology. 2nd World Congress of Inflammation, Antirheumatics, analgesics, immunomodulators. Abstracts, A. Book 1, pg. 116, March 19-22, Montecarlo 1986 3)Stagnaro S., Polimialgia Reumatica Acuta Benigna Variante. Clin. Ter. 118, 193 [Medline]

4)Stagnaro S., Sindrome percusso-ascoltatoria di Iperfunzione del Sistema Reticolo-Istiocitario. Min. Med. 74, 479, 1983 [Medline]

5) Stagnaro S., Sindrome percusso-ascoltatoria autoimmune. Gazz. Med. It. 142, 555. 1983

6) Stagnaro S., Stagnaro-Neri M., Le Costituzioni Semeiotico- Biofisiche.Strumento clinico fondamentale per la prevenzione primaria e la definizione della Single Patient Based Medicine. Travel Factory, Roma, 2004. http://www.travelfactory.it

Conflict of Interest:

None declared

Submit a Comment/Letter

Summary for Patients

Adding Infliximab to the Treatment Regimen for Polymyalgia Rheumatica

The summary below is from the full report titled “Infliximab plus Prednisone or Placebo plus Prednisone for the Initial Treatment of Polymyalgia Rheumatica. A Randomized Trial.” It is in the 1 May 2007 issue of Annals of Internal Medicine (volume 146, pages 631-639). The authors are C. Salvarani, P.L. Macchioni, C. Manzini, G. Paolazzi, A. Trotta, P. Manganelli, M. Cimmino, R. Gerli, M.G. Catanoso, L. Boiardi, F. Cantini, C. Klersy, and G.G. Hunder.


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