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.

Conclusion: 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.

Trial registration: ClinicalTrials.gov NCT00420238.

Copyright © 2012 by the American College of Rheumatology.