title: Etanercept 50 mg once weekly is as effective as 25 mg twice weekly in patients with ankylosing spondylitis.
abstract: OBJECTIVE
  To compare the efficacy, pharmacokinetics and safety of etanercept 50 mg once weekly with 25 mg twice weekly and placebo in patients with ankylosing spondylitis.
  
  
  METHODS
  A 12-week, double-blind, placebo-controlled study compared the effects of etanercept 50 mg once weekly, etanercept 25 mg twice weekly and placebo in 356 patients with active ankylosing spondylitis (3:3:1 randomisation, respectively). The primary end point was the proportion of patients achieving a response at week 12 based on the Assessment in Ankylosing Spondylitis Working Group criteria (ASAS 20). The pharmacokinetics of etanercept 50 mg once weekly and 25 mg twice weekly were analysed.
  
  
  RESULTS
  Baseline characteristics and disease activity were similar among the three groups: etanercept 50 mg once weekly, etanercept 25 mg twice weekly and placebo. The percentage of patients discontinuing therapy was 9.0%, 9.3% and 13.7% for the three respective groups. ASAS 20 response at 12 weeks was achieved by 74.2% of patients with etanercept 50 mg once weekly and 71.3% of those with etanercept 25 mg twice weekly, both significantly higher than the percentage of patients taking placebo (37.3%, p<0.001). Percentages of patients with ASAS 5/6 response (70.3%, 72.0% and 27.5%, respectively; p<0.001) and those with ASAS 40 response (58.1%, 53.3% and 21.6%, respectively; p<0.001) followed a similar pattern. Significant improvement (p<0.05) was seen in measures of disease activity, back pain, morning stiffness and C reactive protein levels as early as 2 weeks. Serum etanercept exposure was similar between the etanercept groups. Incidence of treatment-emergent adverse events, including infections, was similar among all three groups, and no unexpected safety issues were identified.
  
  
  CONCLUSIONS
  Patients with ankylosing spondylitis can expect a comparable significant improvement in clinical outcomes with similar safety when treated with etanercept 50 mg once weekly or with 25 mg twice weekly.
authors.affiliation: University Hospital Maastricht, Maastricht, The Netherlands.
authors.forename: D
authors.initials: D
authors.lastname: van der Heijde
authors.forename: J C
authors.initials: JC
authors.lastname: Da Silva
authors.forename: M
authors.initials: M
authors.lastname: Dougados
authors.forename: P
authors.initials: P
authors.lastname: Geher
authors.forename: I
authors.initials: I
authors.lastname: van der Horst-Bruinsma
authors.forename: X
authors.initials: X
authors.lastname: Juanola
authors.forename: I
authors.initials: I
authors.lastname: Olivieri
authors.forename: F
authors.initials: F
authors.lastname: Raeman
authors.forename: L
authors.initials: L
authors.lastname: Settas
authors.forename: J
authors.initials: J
authors.lastname: Sieper
authors.forename: J
authors.initials: J
authors.lastname: Szechinski
authors.forename: D
authors.initials: D
authors.lastname: Walker
authors.forename: M-P
authors.initials: MP
authors.lastname: Boussuge
authors.forename: J S
authors.initials: JS
authors.lastname: Wajdula
authors.forename: L
authors.initials: L
authors.lastname: Paolozzi
authors.forename: S
authors.initials: S
authors.lastname: Fatenejad
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D008297:Male; D008875:Middle Aged; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage* / Q000097:blood; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000097:blood / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept