title: Treatment of primary Sjögren syndrome with rituximab: a randomized trial.
abstract: BACKGROUND
  Primary Sjögren syndrome (pSS) is an autoimmune disorder characterized by ocular and oral dryness or systemic manifestations.
  
  
  OBJECTIVE
  To evaluate efficacy and harms of rituximab in adults with recent-onset or systemic pSS.
  
  
  METHODS
  Randomized, placebo-controlled, parallel-group trial conducted between March 2008 and January 2011. Study personnel (except pharmacists), investigators, and patients were blinded to treatment group. (ClinicalTrials.gov: NCT00740948).
  
  
  METHODS
  14 university hospitals in France.
  
  
  METHODS
  120 patients with scores of 50 mm or greater on at least 2 of 4 visual analogue scales (VASs) (global disease, pain, fatigue, and dryness) and recent-onset (< 10 years) biologically active or systemic pSS.
  
  
  METHODS
  Randomization (1:1 ratio) to rituximab (1 g at weeks 0 and 2) or placebo.
  
  
  METHODS
  Primary end point was improvement of at least 30 mm in 2 of 4 VASs by week 24.
  
  
  RESULTS
  No significant difference between groups in the primary end point was found (difference, 1.0% [95% CI, -16.7% to 18.7%]). The proportion of patients with at least 30-mm decreases in at least two of the four VAS scores was higher in the rituximab group at week 6 (22.4% vs. 9.1%; P = 0.036). An improvement of at least 30 mm in VAS fatigue score was more common with rituximab at weeks 6 (P < 0.001) and 16 (P = 0.012), and improvement in fatigue from baseline to week 24 was greater with rituximab. Adverse events were similar between groups except for a higher rate of infusion reactions with rituximab.
  
  
  CONCLUSIONS
  Low disease activity at baseline and a primary outcome that may have been insensitive to detect clinically important changes.
  
  
  CONCLUSIONS
  Rituximab did not alleviate symptoms or disease activity in patients with pSS at week 24, although it alleviated some symptoms at earlier time points.
authors.forename: Valérie
authors.initials: V
authors.lastname: Devauchelle-Pensec
authors.forename: Xavier
authors.initials: X
authors.lastname: Mariette
authors.forename: Sandrine
authors.initials: S
authors.lastname: Jousse-Joulin
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Berthelot
authors.forename: Aleth
authors.initials: A
authors.lastname: Perdriger
authors.forename: Xavier
authors.initials: X
authors.lastname: Puéchal
authors.forename: Véronique
authors.initials: V
authors.lastname: Le Guern
authors.forename: Jean
authors.initials: J
authors.lastname: Sibilia
authors.forename: Jacques-Eric
authors.initials: JE
authors.lastname: Gottenberg
authors.forename: Laurent
authors.initials: L
authors.lastname: Chiche
authors.forename: Eric
authors.initials: E
authors.lastname: Hachulla
authors.forename: Pierre Yves
authors.initials: PY
authors.lastname: Hatron
authors.forename: Vincent
authors.initials: V
authors.lastname: Goeb
authors.forename: Gilles
authors.initials: G
authors.lastname: Hayem
authors.forename: Jacques
authors.initials: J
authors.lastname: Morel
authors.forename: Charles
authors.initials: C
authors.lastname: Zarnitsky
authors.forename: Jean Jacques
authors.initials: JJ
authors.lastname: Dubost
authors.forename: Jacques Olivier
authors.initials: JO
authors.lastname: Pers
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Nowak
authors.forename: Alain
authors.initials: A
authors.lastname: Saraux
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects* / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects* / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D000069283:Rituximab; D012859:Sjogren's Syndrome / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D007155:Immunologic Factors; D000069283:Rituximab