Serum urate as a proposed surrogate outcome measure in gout trials: From the OMERACT working group |
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| Affiliation: | 1. Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark;2. Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark;3. Department of Medicine, Svendborg, Odense University Hospital, Denmark;4. Birmingham Veterans Affairs (VA) Medical Center, University of Alabama at Birmingham, Birmingham, AL, USA;5. University of Auckland, New Zealand;6. Birmingham Veterans Affairs (VA) Medical Center, University of Alabama, Birmingham, AL, USA;7. University of Otago, Wellington, New Zealand;8. Rheumatology, Medicine, Boston Medical Center;9. OMERACT Patient Research Partner, Christchurch, New Zealand;10. OMERACT Patient Research Partner, Aarhus, Denmark;11. Division of Rheumatology, Mater Misericordiae University Hospital, Dublin, Ireland;12. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada;13. Rheumatology Department. Hospital de la Santa Creu i Sant Pau. Universitat Autònoma de Barcelona. Barcelona;14. Brigham and Women''s Hospital, Division of Rheumatology, Inflammation and Immunity, Boston, USA;15. Rehabilitation Teaching and Research Unit, Department of Medicine, University of Otago Wellington, Wellington, New Zealand;p. Academic Rheumatology, University of Nottingham, Nottingham, UK;q. SDG LLC, Cambridge, MA, USA;r. Department of Rheumatology, St George Hospital, University of NSW, Sydney, Australia;s. Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada;t. Department of Medicine, University of Otago, Christchurch, New Zealand |
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| 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). |
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