Reduction of fatigue in Sjogren syndrome with rituximab: results of a randomised, double-blind, placebo-controlled pilot study
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- 14 February 2008
- journal article
- research article
- Published by BMJ in Annals Of The Rheumatic Diseases
- Vol. 67 (11), 1541-1544
- https://doi.org/10.1136/ard.2007.083865
Abstract
Objective: Primary Sjögren syndrome (pSS) causes significant systemic symptoms including fatigue as well as glandular dysfunction. There are currently no effective systemic therapies; however, open label series have suggested that rituximab may be beneficial for systemic and glandular manifestations. Therefore, we performed a double blind, placebo-controlled, randomised pilot study of the efficacy of rituximab in reducing fatigue in pSS. Methods: A total of 17 patients with pSS and a score on fatigue visual analogue scale (VAS) >50 were randomised to receive either 2 infusions of rituximab 1 g or placebo; patients also received oral and intravenous steroids. Outcome measures included: the proportion of patients with >20% reduction in fatigue VAS, changes in pSS related symptoms, health related quality of life and immunological parameters of pSS. These were measured 6 months after therapy. Results: There was significant improvement from baseline in fatigue VAS in the rituximab group (pConclusions: This is the first double blind study of rituximab in pSS to show benefit; further studies are justified.Keywords
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