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NEW YORK (Reuters Health) Nov 06 - Results of a pilot study suggest that rituximab may reduce fatigue in patients with Sjogren's syndrome and thus may improve quality of life, UK researchers report in the November issue of the Annals of the Rheumatic Diseases.
Dr. Paul Emery of Allerton Hospital, Leeds, and colleagues studied 17 patients with a fatigue score of more than 50 on a 100-mm visual analogue scale. They were randomized in a double-blind fashion to receive 2 infusions of rituximab 1 g or placebo. All patients also received oral and intravenous steroids.
At 6 months, 7 of the 8 patients receiving rituximab showed a greater than 20% improvement in the VAS for fatigue. This was true of only 5 of the 9 patients who had placebo.
Overall, there was a significant 36.8% improvement in fatigue VAS in the rituximab group compared to a non-significant 17.9% improvement in the placebo group. General health was also significantly improved in the active treatment group, but not in the placebo group.
There was also a significant difference in measures of social functioning and a trend towards improved mental health scoring in the rituximab group.
Commenting on the findings, Dr. Emery told Reuters Health that "this was the first randomized controlled trial in Sjogren's syndrome to show benefit, in particular a significant improvement in fatigue, a major issue for patients. This pilot study will now be followed by a more definitive study."
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