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

Maxime Dougados, Jurgen Braun, S. Szántó, Bernard Combe, P. Géher, Véronique Leblanc, Isabelle Logeart

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)290-294
Number of pages5
JournalArthritis Care and Research
Volume64
Issue number2
DOIs
Publication statusPublished - Feb 2012

Fingerprint

Ankylosing Spondylitis
Anti-Inflammatory Agents
Tumor Necrosis Factor-alpha
Clinical Trials
Pharmaceutical Preparations
Placebos
Spondylarthritis
Feasibility Studies
Non-Steroidal Anti-Inflammatory Agents
Etanercept
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Rheumatology
  • Medicine(all)

Cite this

@article{baa194e83b9f4f63b09bd40bb9f397d8,
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 = "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.",
author = "Maxime Dougados and Jurgen Braun and S. Sz{\'a}nt{\'o} and Bernard Combe and P. G{\'e}her and V{\'e}ronique Leblanc and Isabelle Logeart",
year = "2012",
month = "2",
doi = "10.1002/acr.20671",
language = "English",
volume = "64",
pages = "290--294",
journal = "Arthritis and Rheumatology",
issn = "2326-5191",
publisher = "John Wiley and Sons Ltd",
number = "2",

}

TY - JOUR

T1 - Nonsteroidal antiinflammatory drug intake according to the assessment of spondyloarthritis international society score in clinical trials evaluating tumor necrosis factor blockers

T2 - Example of etanercept in advanced ankylosing spondylitis

AU - Dougados, Maxime

AU - Braun, Jurgen

AU - Szántó, S.

AU - Combe, Bernard

AU - Géher, P.

AU - Leblanc, Véronique

AU - Logeart, Isabelle

PY - 2012/2

Y1 - 2012/2

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84858029602&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84858029602&partnerID=8YFLogxK

U2 - 10.1002/acr.20671

DO - 10.1002/acr.20671

M3 - Article

C2 - 22006544

AN - SCOPUS:84858029602

VL - 64

SP - 290

EP - 294

JO - Arthritis and Rheumatology

JF - Arthritis and Rheumatology

SN - 2326-5191

IS - 2

ER -