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Reduction of fatigue in Sjögren syndrome with rituximab: results of a randomised, double-blind, placebo-controlled pilot study
  1. S Dass1,
  2. S J Bowman2,
  3. E M Vital1,
  4. K Ikeda1,
  5. C T Pease1,
  6. J Hamburger3,
  7. A Richards3,
  8. S Rauz4,
  9. P Emery1
  1. 1
    Academic Unit of Musculoskeletal Disease, University of Leeds, Leeds, UK
  2. 2
    Department of Rheumatology, Selly Oak Hospital, Birmingham, UK
  3. 3
    Department of Oral Medicine, Birmingham Dental Hospital and School, Birmingham, UK
  4. 4
    Academic Unit of Ophthalmology, University of Birmingham, Birmingham, UK
  1. P Emery, Academic Unit of Musculoskeletal Disease, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK; p.emery{at}


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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  • Funding: Roche UK provided study drug and an educational support grant to cover the costs of blood tests performed during this study.

  • Competing interests: None declared.

  • Ethics approval: The protocol was approved by the local ethics committees and all patients gave written, informed consent.