RESEARCH - Reduction of fatigue in Sjögren syndrome with rituximab

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Published Online First: 14 February 2008. doi:10.1136/ard.2007.083865

ls of the Rheumatic Diseases 2008;67:1541-1544

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CLINICAL AND EPIDEMIOLOGICAL RESEARCH

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

randomised, double-blind, placebo-controlled pilot study

S Dass 1, S J Bowman 2, E M Vital 1, K Ikeda 1, C T Pease 1, J

Hamburger 3, A s 3, S Rauz 4, P Emery 1

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

2 Department of Rheumatology, Selly Oak Hospital, Birmingham, UK

3 Department of Oral Medicine, Birmingham Dental Hospital and School,

Birmingham, UK

4 Academic Unit of Ophthalmology, University of Birmingham, Birmingham, 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.

http://ard.bmj.com/cgi/content/abstract/67/11/1541?etoc

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