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Review
. 2021 Dec;51(6):1378-1385.
doi: 10.1016/j.semarthrit.2021.11.004. Epub 2021 Nov 15.

Serum urate as a proposed surrogate outcome measure in gout trials: From the OMERACT working group

Melanie Birger Morillon  1 , Robin Christensen  2 , Jasvinder A Singh  3 , Nicola Dalbeth  4 , Kenneth Saag  5 , William J Taylor  6 , Tuhina Neogi  7 , Martin A Kennedy  8 , Birthe M Pedersen  9 , Geraldine M McCarthy  10 , Beverley Shea  11 , Cesar Diaz-Torne  12 , Sara K Tedeschi  13 , Rebecca Grainger  14 , Abhishek Abhishek  15 , Angelo Gaffo  3 , Sabrina Mai Nielsen  2 , Alexander Noerup  2 , Lee S Simon  16 , Marissa Lassere  17 , Peter Tugwell  18 , Lisa K Stamp  19 , For The Omeract Gout Working Group  20
Affiliations
Review

Serum urate as a proposed surrogate outcome measure in gout trials: From the OMERACT working group

Melanie Birger Morillon et al. Semin Arthritis Rheum. 2021 Dec.

Abstract

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).

Keywords: Biomarker; Gout; OMERACT; Patient Research Partners; Serum urate; Surrogate.

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Conflict of interest statement

Declaration of Competing Interest MBM: No conflicts declared, RC: No conflicts declared, JAS: Has received consultant fees from Crealta/Horizon, Medisys, Fidia, PK Med, Two labs Inc., Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, MedIQ, Jupiter Life Science, UBM LLC, Trio Health, Medscape, WebMD, and Practice Point communications; and the National Institutes of Health and the American College of Rheumatology. JAS owns stock options in TPT Global Tech, Vaxart pharmaceuticals and Charlotte's Web Holdings, Inc. JAS previously owned stock options in Amarin, Viking and Moderna pharmaceuticals. JAS is on the speaker's bureau of Simply Speaking. JAS is a member of the executive of Outcomes Measures in Rheumatology (OMERACT), an organization that develops outcome measures in rheumatology and receives arms-length funding from 12 companies. JAS serves on the FDA Arthritis Advisory Committee. JAS is the chair of the Veterans Affairs Rheumatology Field Advisory Committee. JAS is the editor and the Criteria subcommittee. Director of the University of Alabama at Birmingham (UAB) Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis. JAS previously served as a member of the following committees: member, the American College of Rheumatology's (ACR) Annual Meeting Planning Committee (AMPC) and Quality of Care Committees, the Chair of the ACR Meet-the-Professor, Workshop and Study Group Subcommittee and the co-chair of the ACR Criteria and Response, ND: Reports consulting fees from AstraZeneca, Dyve BioSciences, Selecta, Horizon, and Arthrosi, speaker fees from Abbvie and Janssen, and research grants from Amgen and AstraZeneca, outside the submitted work. ORCID: 0000-0003-3485-0006, KS: Reports he is an Investigator for Horizon, Sobi, LG, Dyve and consulting fees from Horizon, WJT: No conflicts declared ORCID 0000-0001-6075-8479, TN: No conflicts declared. ORCID 000-002-9515-1711, MK: No conflicts declared ORCID 0000-0002-6445-8526, BMP: No conflicts declared, GMM: No conflicts declared, BJS: Is the senior Methodologist. ORCID 0000-0002-7686-2585, CDT: No conflicts declared. ORCID 0000-0001-6275-7699, SKT: No conflicts declared, RG: personal fees from Pfizer, Cornerstones, Jannsen, and Novartis. AA: No conflicts declared, ML: No conflicts declared, AG: No conflicts declared ORCID 0000-0001-7365-7212, LSS: Serves as a consultant to Horizon Therapeutics. He serves on the Executive of OMERACT and is Chair of the Finance Committee of OMERACT and Co-Chair of It's Business Advisory Committee., AN: No conflicts declared, SMN: No conflicts declared, ML: No conflicts declared, PT: No conflicts declared ORCID 00000-0001-5062-0556, LKS: No conflicts declared ORCID 0000-0003-0138-2912

Figures

Figure 4
Figure 4
Figure 1.
Figure 1.
Attendees at the OMERACT gout virtual special interest group meeting 2020.
Figure 2.
Figure 2.
Association between SU and number of flares per patient year (Adapted from Stamp et al[19] with permission from Elsvier Inc License number 5130431327480).
Figure 3.
Figure 3.
Study design [24]
See this image and copyright information in PMC

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