title: Effects of rituximab therapy on quality of life in patients with primary Sjögren's syndrome.
abstract: OBJECTIVE
  To assess the efficacy of the anti-CD20 antibody rituximab in improving physical function and health-related quality of life (HRQoL) in patients with active primary Sjögren's syndrome (pSS), as well as the duration and sources of HRQoL improvements.
  
  
  METHODS
  Sixteen patients with pSS received rituximab infusions (375 mg/m2) at weeks 0 and 1 and were followed up for 36 weeks. All patients fulfilled 2002 American-European Consensus Group criteria for pSS and had active disease defined as scores >50 mm on two of four 100-mm visual analogue scales (VAS) evaluating global disease activity, fatigue, pain, and dryness. Standardised evaluations including the Short Form 36 Health Survey (SF-36) were conducted. SF-36 score changes from baseline to weeks 12, 24, and 36 were assessed.
  
  
  RESULTS
  Baseline mean SF-36 scores were considerably decreased, compared to the general same-age population. Role-physical (14.1 ± 27.4), role-emotional (12.5 ± 29.9), vitality (26.2 ± 14.3), and general health (32.6 ± 11.2) were the dimensions with the worst scores. Twelve weeks after rituximab, the mental component summary score was improved in 15 patients (mean improvement, 31.2 ± 36.4, p=0.001) and the physical component summary score in 14 patients (mean improvement, 16.9 ± 26.2, p=0.049). Further improvements occurred from week 12 to week 24, and most of the gains were sustained at week 36. Improvements in the physical and mental component summary scores failed to correlate with improvements in the VAS scores.
  
  
  CONCLUSIONS
  Substantial alterations in HRQoL were noted in patients with pSS. Rituximab infusions without corticosteroid therapy produced meaningful improvements in HRQoL. Controlled studies of rituximab are needed.
authors.affiliation: Rheumatology Unit,CHU Brest, France. valerie.devauchelle-pensec@chu-brest.fr
authors.forename: Valérie
authors.initials: V
authors.lastname: Devauchelle-Pensec
authors.forename: Johanne
authors.initials: J
authors.lastname: Morvan
authors.forename: Anne-Christine
authors.initials: AC
authors.lastname: Rat
authors.forename: Sandrine
authors.initials: S
authors.lastname: Jousse-Joulin
authors.forename: Yan
authors.initials: Y
authors.lastname: Pennec
authors.forename: Jaques-Olivier
authors.initials: JO
authors.lastname: Pers
authors.forename: Christophe
authors.initials: C
authors.lastname: Jamin
authors.forename: Yves
authors.initials: Y
authors.lastname: Renaudineau
authors.forename: Isabelle
authors.initials: I
authors.lastname: Quintin-Roué
authors.forename: Beatrice
authors.initials: B
authors.lastname: Cochener
authors.forename: Pierre
authors.initials: P
authors.lastname: Youinou
authors.forename: Alain
authors.initials: A
authors.lastname: Saraux
mesh_terms: D000293:Adolescent; D000328:Adult; D058846:Antibodies, Monoclonal, Murine-Derived / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain; D011788:Quality of Life; D000069283:Rituximab; D012720:Severity of Illness Index; D012859:Sjogren's Syndrome / Q000188:drug therapy* / Q000503:physiopathology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents; D000069283:Rituximab