Reduction of fatigue in Sjögren syndrome with rituximab: results of a randomised, double-blind, placebo-controlled pilot study
- S Dass1,
- S J Bowman2,
- E M Vital1,
- K Ikeda1,
- C T Pease1,
- J Hamburger3,
- A Richards3,
- S Rauz4,
- P Emery1
- 1Academic Unit of Musculoskeletal Disease, University of Leeds, Leeds, UK
- 2Department of Rheumatology, Selly Oak Hospital, Birmingham, UK
- 3Department of Oral Medicine, Birmingham Dental Hospital and School, Birmingham, UK
- 4Academic Unit of Ophthalmology, University of Birmingham, Birmingham, UK
- P Emery, Academic Unit of Musculoskeletal Disease, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK;
- Accepted 28 January 2008
- Published Online First 14 February 2008
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.
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.