RESEARCH - Reduction of fatigue in Sjogren's syndrome with rituximab

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Ann Rheum Dis. 2008 Nov;67(11):1541-4. Epub 2008 Feb 14.

Reduction of fatigue in Sjögren syndrome with rituximab: results of a

randomised, double-blind, placebo-controlled pilot study.

Dass S, Bowman SJ, Vital EM, Ikeda K, Pease CT, Hamburger J, s

A, Rauz S, Emery P.

Academic Unit of Musculoskeletal Disease, University of Leeds, Leeds, UK.

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.

PMID: 18276741

http://www.ncbi.nlm.nih.gov/pubmed/18276741

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