title: Reduction of fatigue in Sjögren syndrome with rituximab: results of a randomised, double-blind, placebo-controlled pilot study.
abstract: 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.
authors.affiliation: Academic Unit of Musculoskeletal Disease, University of Leeds, Leeds, UK.
authors.forename: S
authors.initials: S
authors.lastname: Dass
authors.forename: S J
authors.initials: SJ
authors.lastname: Bowman
authors.forename: E M
authors.initials: EM
authors.lastname: Vital
authors.forename: K
authors.initials: K
authors.lastname: Ikeda
authors.forename: C T
authors.initials: CT
authors.lastname: Pease
authors.forename: J
authors.initials: J
authors.lastname: Hamburger
authors.forename: A
authors.initials: A
authors.lastname: Richards
authors.forename: S
authors.initials: S
authors.lastname: Rauz
authors.forename: P
authors.initials: P
authors.lastname: Emery
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010865:Pilot Projects; D011788:Quality of Life; D000069283:Rituximab; D012720:Severity of Illness Index; D012859:Sjogren's Syndrome / Q000150:complications* / Q000188:drug therapy* / Q000276:immunology; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D000069283:Rituximab