Reduction of fatigue in Sjögren syndrome with rituximab: results of a randomised, double-blind, placebo-controlled pilot study
Annals of the rheumatic diseases, 2008•ard.bmj.com
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 …
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 …
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 (p<0.001) in contrast to the placebo group (p = 0.147). There was a significant difference between the groups at 6 months in the social functioning score of SF-36 (p = 0.01) and a trend to significant difference in the mental health domain score of SF-36 (p = 0.06). There was one episode of serum sickness in the rituximab treated group.
Conclusions
This is the first double blind study of rituximab in pSS to show benefit; further studies are justified.
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