title: Nonsteroidal antiinflammatory drug intake according to the Assessment of SpondyloArthritis International Society Score in clinical trials evaluating tumor necrosis factor blockers: example of etanercept in advanced ankylosing spondylitis.
abstract: OBJECTIVE
  To evaluate the interest of the Assessment of SpondyloArthritis international Society (ASAS) nonsteroidal antiinflammatory drug (NSAID) score as a quality indicator and a potential outcome measure in clinical studies.
  
  
  METHODS
  We used data from patients with active, advanced, axial ankylosing spondylitis refractory to NSAIDs. The study design was a 12-week, randomized, placebo-controlled period followed by a 12-week open-label extension. The ASAS-NSAID score was collected during 3 periods of interest (i.e., the 12 weeks preceding baseline, the 12 weeks of the placebo-controlled trial, and the 12 weeks of the open-label trial).
  
  
  RESULTS
  For the 82 enrolled patients, the mean ± SD ASAS-NSAID score at baseline was similar between the 2 groups: 93 ± 76 and 74 ± 54 in the etanercept and placebo groups, respectively. There was no significant change in the ASAS-NSAID score during the first part of the trial, as recommended by the protocol. There was a statistically significant decrease in the ASAS-NSAID score during the second part of the trial with a relevant effect size (-0.56) in the placebo to etanercept group.
  
  
  CONCLUSIONS
  This study confirms the feasibility and simplicity of the ASAS-NSAID score and suggests that such a score be integrated in all studies in spondylarthritis either to check the quality of the observed data (i.e., intergroup baseline characteristics) or to evaluate the NSAID-sparing effect of other therapies.
authors: Paris-Descartes University, UPRES-EA 4058, AP-HP, Cochin Hospital, Paris 14, France. maxime.dougados@cch.aphp.fr
authors: Maxime
authors: M
authors: Dougados
authors: Jurgen
authors: J
authors: Braun
authors: Sandor
authors: S
authors: Szanto
authors: Bernard
authors: B
authors: Combe
authors: Pal
authors: P
authors: Geher
authors: Véronique
authors: V
authors: Leblanc
authors: Isabelle
authors: I
authors: Logeart
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D016903:Drug Monitoring / Q000379:methods*; D004363:Drug Utilization / Q000706:statistics & numerical data*; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D013167:Spondylitis, Ankylosing / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept