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
✍ Scribed by Maxime Dougados; Jurgen Braun; Sandor Szanto; Bernard Combe; Pal Geher; Véronique Leblanc; Isabelle Logeart
- Publisher
- Wiley (John Wiley & Sons)
- Year
- 2012
- Tongue
- English
- Weight
- 69 KB
- Volume
- 64
- Category
- Article
- ISSN
- 2151-464X
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✦ Synopsis
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.