• S Dass, S J Bowman, E M Vital, K Ikeda, C T Pease, J Hamburger, A Richards, S Rauz, and P Emery.
• Academic Unit of Musculoskeletal Disease, University of Leeds, Leeds, UK.
• Ann. Rheum. Dis. 2008 Nov 1; 67 (11): 1541-4.

ObjectivePrimary 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.MethodsA 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.ResultsThere 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.ConclusionsThis is the first double blind study of rituximab in pSS to show benefit; further studies are justified.

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