title: Etanercept in Sjögren's syndrome: a twelve-week randomized, double-blind, placebo-controlled pilot clinical trial.
abstract: OBJECTIVE
  To assess the safety and potential efficacy of etanercept in the treatment of Sjögren's syndrome (SS).
  
  
  METHODS
  This pilot study was a 12-week randomized, double-blind, placebo-controlled trial of etanercept, with 14 subjects in each group. Patients received 25 mg of etanercept or placebo (vehicle) by twice-weekly subcutaneous injection. Patients met the American-European Consensus Group criteria for SS. The primary outcome required at least 20% improvement from baseline values for at least 2 of the following 3 domains: subjective or objective measures of dry mouth, subjective or objective measures of dry eyes, and IgG level or erythrocyte sedimentation rate (ESR).
  
  
  RESULTS
  Of the 14 patients taking etanercept, 11 had primary SS and 3 had SS secondary to rheumatoid arthritis. Baseline measures did not differ between the 2 groups. Three etanercept-treated patients and 1 placebo-treated patient did not complete the trial. Five etanercept-treated patients and 3 placebo-treated patients showed improvement from baseline in the primary outcome variable at 12 weeks, but the difference was not statistically significant. There were no significant differences between the groups for changes in subjective measures of oral or ocular symptoms (by visual analog scale), the IgG level, Schirmer I test result, van Bijsterveld score, or salivary flow. At 12 weeks, the ESR had decreased in the etanercept group compared with baseline (P = 0.004); however, the mean reduction was only 18.6%.
  
  
  CONCLUSIONS
  We found no evidence to suggest that treatment with etanercept at a dosage of 25 mg twice weekly for 12 weeks was clinically efficacious in SS. A larger trial will be necessary to definitively address the efficacy of etanercept in the treatment of SS.
authors.affiliation: National Institutes of Health, Bethesda, Maryland, USA. sankarv@uthscsa.edu
authors.forename: Vidya
authors.initials: V
authors.lastname: Sankar
authors.forename: Michael T
authors.initials: MT
authors.lastname: Brennan
authors.forename: Marc R
authors.initials: MR
authors.lastname: Kok
authors.forename: Rose Anne
authors.initials: RA
authors.lastname: Leakan
authors.forename: Janine A
authors.initials: JA
authors.lastname: Smith
authors.forename: Joan
authors.initials: J
authors.lastname: Manny
authors.forename: Bruce J
authors.initials: BJ
authors.lastname: Baum
authors.forename: Stanley R
authors.initials: SR
authors.lastname: Pillemer
mesh_terms: D001172:Arthritis, Rheumatoid / Q000150:complications; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010919:Placebos; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D012859:Sjogren's Syndrome / Q000188:drug therapy* / Q000209:etiology; D017211:Treatment Failure
chemical_list: D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D010919:Placebos; D018124:Receptors, Tumor Necrosis Factor; D011993:Recombinant Fusion Proteins; D000068800:Etanercept