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Does Rituximab Help Patients With Primary Sjögren Syndrome? FREE

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The full report is titled “Treatment of Primary Sjögren Syndrome With Rituximab. A Randomized Trial.” It is in the 18 February 2014 issue of Annals of Internal Medicine (volume 160, pages 233-242). The authors are V. Devauchelle-Pensec, X. Mariette, S. Jousse-Joulin, J.M. Berthelot, A. Perdriger, X. Puéchal, V. Le Guern, J. Sibilia, J.E. Gottenberg, L. Chiche, E. Hachulla, P.Y. Hatron, V. Goeb, G. Hayem, J. Morel, C. Zarnitsky, J.J. Dubost, J.O. Pers, E. Nowak, and A. Saraux.

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Ann Intern Med. 2014;160(4):I-11. doi:10.7326/P14-9005
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What is the problem and what is known about it so far?

The Sjögren syndrome is an autoimmune disorder that usually affects women aged 40 to 50 years. It occurs when white blood cells attack the salivary and tear glands, reducing tear and saliva production. The cause is unknown. The main symptoms are dry eyes and dry mouth, and fatigue and joint pain may also occur. Current treatment focuses on relieving symptoms and includes drugs to increase saliva production and minor surgery to relieve dry eyes. Two small clinical trials have tested the effects of rituximab for treating primary Sjögren syndrome (pSS). People with pSS do not have other autoimmune disorders. Rituximab is a drug that is used to restore normal functioning of the immune system. The results of the trials were unclear, but they suggested that rituximab might reduce symptoms and disease activity.

Why did the researchers do this particular study?

To find out whether rituximab is effective and safe for treating pSS.

Who was studied?

120 patients aged 18 to 80 years with pSS. All patients were taking nonsteroidal anti-inflammatory drugs, such as ibuprofen or acetaminophen, but not drugs that suppressed the immune system.

How was the study done?

Researchers recruited patients from 14 university hospitals in France between March 2008 and January 2011. Patients received infusions of rituximab (1 g) or placebo at the beginning of the trial and at week 2. (A course of rituximab is generally given once every 6 months, consisting of 2 infusions given 2 weeks apart.) Researchers measured changes in overall disease activity, pain, fatigue, and dryness at weeks 6, 16, and 24 using visual analogue scales (VASs). A VAS consists of a 100-mm line on which patients mark symptom intensity from low to high. The primary outcome was an improvement of at least 30 mm in at least 2 of the 4 VAS scores at week 24 compared with the start of the trial.

What did the researchers find?

Sixty-three patients received rituximab, and 57 received placebo. At week 24, the researchers compared the 2 groups and found no significant difference in the primary outcome: 23% of patients in the rituximab group had decreases of at least 30 mm in at least 2 of the 4 VAS symptom scores compared with 22% in the placebo group. Patients in the rituximab group reported a greater reduction in fatigue at week 24.

Rituximab alleviated some symptoms at earlier time points. In particular, at week 6, a significantly greater number of the patients in the rituximab group had decreases of at least 30 mm in at least 2 of the VAS symptom scores (22% for rituximab vs. 9% for placebo). Infusion reactions were significantly more common in the rituximab group.

What were the limitations of the study?

The primary outcome may not have detected important changes in patient symptoms and disease activity.

What are the implications of the study?

Rituximab did not provide lasting benefit for patients with pSS.





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