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ABSTRACT: Objectives
To evaluate different methods of reporting response to treatment or disease status for their ability to discriminate between active therapy and placebo, or to reflect structural progression or patient satisfaction with treatment using an exploratory analysis of the Abatacept in Inadequate Responders to Methotrexate (AIM) trial.Methods
424 active (abatacept approximately 10 mg/kg) and 214 placebo-treated patients with rheumatoid arthritis (RA) were evaluated.Method
of reporting included: (1) response (American College of Rheumatology (ACR) criteria) versus state (disease activity score in 28 joints (DAS28) criteria); (2) stringency (ACR20 vs 50 vs 70; moderate disease activity state (MDAS; DAS28 <5.1) vs low disease activity state (LDAS; DAS28 Conclusions
The optimal method for reporting a measure of disease activity may differ depending on the outcome of interest. Time to onset and sustainability can be important factors when evaluating treatment response and disease status in patients with RA.
SUBMITTER: Dougados M
PROVIDER: S-EPMC2651483 | biostudies-literature | 2009 Apr
REPOSITORIES: biostudies-literature
Dougados M M Schmidely N N Le Bars M M Lafosse C C Schiff M M Smolen J S JS Aletaha D D van Riel P P Wells G G
Annals of the rheumatic diseases 20081211 4
<h4>Objectives</h4>To evaluate different methods of reporting response to treatment or disease status for their ability to discriminate between active therapy and placebo, or to reflect structural progression or patient satisfaction with treatment using an exploratory analysis of the Abatacept in Inadequate Responders to Methotrexate (AIM) trial.<h4>Methods</h4>424 active (abatacept approximately 10 mg/kg) and 214 placebo-treated patients with rheumatoid arthritis (RA) were evaluated.<h4>Method< ...[more]