title: Long-term outcome of patients with active ankylosing spondylitis with etanercept-sustained efficacy and safety after seven years.
abstract: BACKGROUND
  Data from clinical studies on the long-term efficacy and safety of anti-tumor necrosis factor (TNF)-α therapy in patients with ankylosing spondylitis (AS) are scarce. This is the first report on continuous treatment with the TNFα fusion protein etanercept over seven years (y).
  
  
  METHODS
  Overall, 26 patients with active AS were initially treated with etanercept 2 × 25 mg s.c./week with no concomitant disease modifying anti-rheumatic drugs (DMARDs) or steroids. The clinical response was assessed by standardized parameters. The primary outcome was the proportion of patients in the Spondyloarthritis International Society (ASAS) partial remission at seven years. AS disease activity scores (ASDAS) for status and improvement were compared to conventional outcome measures.
  
  
  RESULTS
  Overall, 21/26 patients (81%) completed two years of treatment and 16/26 patients (62%) completed seven years. In the completer analysis, 31% patients were in ASAS partial remission at seven years, while 44% patients showed an ASDAS inactive disease status. Mean Bath AS activity index (BASDAI) scores, which were elevated at baseline (6.3 ± 0.9), showed constant improvement and remained low: 3.1 ± 2.5 at two years and 2.5 ± 2.2 at seven years, while ASDAS also improved (3.9 ± 0.7 at baseline, 1.8 ± 0.9 at two years, 1.6 ± 0.8 at seven years), all P <0.001. From the 10 dropouts, only 5 patients discontinued treatment due to adverse events. Patients who completed the study had lower baseline Bath AS function index (BASFI) scores vs. patients who discontinued. No other clinical parameter at baseline could predict any long-term outcome.
  
  
  CONCLUSIONS
  This study confirms the clinical efficacy and safety of etanercept in patients with active AS over seven years of continuous treatment. After seven years, more than half of the initially treated patients remained on anti-TNF therapy, and one-third were in partial remission.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01289743
authors.forename: Xenofon
authors.initials: X
authors.lastname: Baraliakos
authors.forename: Hildrun
authors.initials: H
authors.lastname: Haibel
authors.forename: Claudia
authors.initials: C
authors.lastname: Fritz
authors.forename: Joachim
authors.initials: J
authors.lastname: Listing
authors.forename: Frank
authors.initials: F
authors.lastname: Heldmann
authors.forename: Juergen
authors.initials: J
authors.lastname: Braun
authors.forename: Joachim
authors.initials: J
authors.lastname: Sieper
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D018450:Disease Progression; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D008297:Male; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D012074:Remission Induction; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D013995:Time; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept