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.

• Authors: Maxime Dougados, Jurgen Braun, Sandor Szanto, Bernard Combe, Pal Geher, Véronique Leblanc, Isabelle Logeart
• Journal: Arthritis care & research (Arthritis Care Res (Hoboken)) Vol. 64 Issue 2 Pg. 290-4 (Feb 2012) ISSN: 2151-4658 [Electronic] United States
• PMID: 22006544 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 by the American College of Rheumatology.

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Immunoglobulin G
• Receptors, Tumor Necrosis Factor
• Etanercept

Topics

• Anti-Inflammatory Agents, Non-Steroidal (therapeutic use)
• Drug Administration Schedule
• Drug Monitoring (methods)
• Drug Utilization (statistics & numerical data)
• Etanercept
• Female
• Humans
• Immunoglobulin G (therapeutic use)
• Male
• Middle Aged
• Receptors, Tumor Necrosis Factor (therapeutic use)
• Spondylitis, Ankylosing (drug therapy, physiopathology)