Adding Infliximab to the Treatment Regimen for Polymyalgia Rheumatica

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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.

What is the problem and what is known about it so far?

Polymyalgia rheumatica (PMR) is a disease in which inflammation occurs throughout the body. Symptoms include weight loss; fever; muscle pain; aching of the neck, shoulder, and hip; and morning stiffness. The cause of PMR is unknown. It occurs most often in persons older than 50 years of age and increasingly often with advancing age. Polymyalgia rheumatica responds well to treatment with steroids, such as prednisone. However, patients usually need to stay on steroids for 1 to 2 years, and symptoms sometimes return (relapse) when steroid treatment is stopped. Patients can develop side effects from steroids, so we need better ways to treat PMR to decrease relapse and the amount of steroids needed to treat the disease. Infliximab is a drug that interacts with the immune system. A report suggested that infliximab decreased the amount of steroids needed in 4 patients with PMR who developed side effects from steroid treatment.

Why did the researchers do this particular study?

To find out whether treatment with infliximab improved outcomes for people with PMR.

Who was studied?

The researchers studied 51 patients with newly diagnosed PMR that were being treated with the steroid prednisone.

How was the study done?

The researchers assigned patients at random to receive an intravenous dose of either infliximab or a placebo (a substance that looked like infliximab but contained no active ingredient) at the start of the study and then after 2, 6, 14, and 22 weeks. All patients followed a schedule to slowly decrease the steroid dose from 15 mg to 0 mg over 16 weeks. If symptoms returned, they would need to increase the steroid dose and start to decrease the amount they received all over again. The researchers collected information on whether patients' symptoms returned (relapse) and on steroid dose over the course of the study.

What did the researchers find?

Infliximab did not seem to offer a large benefit in terms of preventing relapse of symptoms or in reducing the amount of steroids required for treatment of PMR.

What were the limitations of the study?

The study was small and lasted only 22 weeks, so the researchers could not rule out a small benefit of infliximab or a benefit if used for a longer period. Also, the study was too small to provide good information on the side effects of infliximab.

What are the implications of the study?

Infliximab is unlikely to result in large benefits when added to prednisone for patients with newly diagnosed PMR.