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Reduction of fatigue in Sjögren's syndrome with rituximab: results of a randomised, double-blind, placebo controlled pilot study
  1. Shouvik Dass (shouvikdass{at}yahoo.co.uk)
  1. Academic Section of Musculoskeletal Disease, University of Leeds, United Kingdom
    1. Simon J Bowman (s.j.bowman{at}bham.ac.uk)
    1. Department of Rheumatology, Selly Oak Hospital, United Kingdom
      1. Edward M Vital (e.m.j.vital{at}leeds.ac.uk)
      1. Academic Section of Musculoskeletal Disease, University of Leeds, United Kingdom
        1. Kei Ikeda (ikekei0513{at}gmail.com)
        1. Academic Section of Musculoskeletal Disease, University of Leeds, United Kingdom
          1. Colin T Pease (colin.pease{at}leedsth.nhs.uk)
          1. Academic Section of Musculoskeletal Disease, University of Leeds, United Kingdom
            1. John Hamburger (j.hamburger{at}bham.ac.uk)
            1. Department of Oral Medicine, Birmingham Dental Hospital & School, United Kingdom
              1. Andrea Richards (andrea.richards{at}sbpct.nhs.uk)
              1. Department of Oral Medicine, Birmingham Dental Hospital & School, United Kingdom
                1. Saaeha Rauz (s.rauz{at}bham.ac.uk)
                1. Academic Unit of Ophthalmology, University of Birmingham, United Kingdom
                  1. Paul Emery (p.emery{at}leeds.ac.uk)
                  1. Academic Section of Musculoskeletal Disease, University of Leeds, United Kingdom

                    Abstract

                    Objective: Primary Sjögren’s 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: 17 patients with pSS and a score on fatigue visual analogue scale (VAS) >50 were randomised to receive either 2 infusions of rituximab 1g 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.

                    • Sjögren's syndrome
                    • b-cells
                    • fatigue
                    • rituximab

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