Serum Urate as a Proposed Surrogate Outcome Measure in Gout Trials: From the OMERACT Working Group.

Melanie Birger Morillon,Robin Christensen,Jasvinder A Singh,Nicola Dalbeth,Kenneth Saag,William J Taylor,Tuhina Neogi,Martin A Kennedy, Birthe M Pedersen,Geraldine M McCarthy,Beverley Shea,Cesar Diaz-Torne,Sara K Tedeschi,Rebecca Grainger,Abhishek Abhishek,Angelo Gaffo,Sabrina Mai Nielsen, Alexander Noerup,Lee S Simon,Marissa Lassere,Peter Tugwell,Lisa K Stamp, For The Omeract Gout Working Group

Seminars in arthritis and rheumatism（2021）

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摘要

Serum urate (SU) is the most common primary efficacy outcome in trials of urate-lowering therapies for gout. Despite this, it is not formally considered a validated surrogate outcome. In this paper we will outline the definitions of biomarkers and surrogate outcome measures, respectively as well as the available frameworks and challenges in the assessment of the validity of serum urate as a surrogate in gout (i.e. a reasonable replacement for gout symptoms).

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关键词

Biomarker,Gout,OMERACT,Patient Research Partners,Serum urate,Surrogate

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