TY - JOUR T1 - Reduction of fatigue in Sjögren syndrome with rituximab: results of a randomised, double-blind, placebo-controlled pilot study JF - Annals of the Rheumatic Diseases JO - Ann Rheum Dis SP - 1541 LP - 1544 DO - 10.1136/ard.2007.083865 VL - 67 IS - 11 AU - S Dass AU - S J Bowman AU - E M Vital AU - K Ikeda AU - C T Pease AU - J Hamburger AU - A Richards AU - S Rauz AU - P Emery Y1 - 2008/11/01 UR - http://ard.bmj.com/content/67/11/1541.abstract N2 - 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. ER -