Change in serum urate level with urate-lowering therapy initiation associates in the immediate term with patient-reported outcomes in people with gout.

To examine the associations of changes in serum urate (SU) with health-related quality of life (HRQOL) in gout. We used the first 6-months of data from four interventional trials and one observational, open-label study of urate-lowering therapy (ULT) use. HRQOL were assessed at baseline and every 3-months, and SU was measured monthly. Primary outcome measures were Short-form 36 physical and mental component summary scores, Health Assessment Questionnaire Disability Index (HAQ-DI), Sheehan Disability Scale (SDS), Patient Global Assessment, and pain scores in the last week. Linear mixed models for each outcome were adjusted as appropriate for current SU, change in urate in the last month, number of flare-affected days in the last month, baseline BMI, age, comorbidities, sex, ethnicity, trial/study and treatment combination, and tophi status (fixed effects); subject, and the trial/study month were random effects. Higher current SU correlated with reduced physical and mental HRQOL, and increased SDS and pain but not with HAQ-DI score. In the first 6-months of new/escalating ULT use, absolute change in SU levels associated with poorer outcomes on the HAQ-DI scale (β (95% CI) = 0.013 (0.007-0.019)) and poorer outcomes on SDS, SF-36 MCS, patient global and pain scales. Reduction of SU associated with poorer outcomes in all six measures. High SU levels were associated with poorer HRQOL, pain and Sheehan disability score. Recent SU level fluctuations are associated with poorer outcomes, primarily driven by a reduction in SU. Clinical emphasis on slow rather than fast SU reduction and the routine use of effective, anti-inflammatory medications at ULT initiation/escalation may avoid short-term poor outcomes.

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Copyright © 2022. Published by Elsevier Inc.

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Declaration of Competing Interests 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 has received institutional research support from Zimmer Biomet Holdings. JAS received food and beverage payments from Intuitive Surgical Inc./Philips Electronics North America. JAS owns stock options in TPT Global Tech, Vaxart pharmaceuticals, Atyu biopharma, Adaptimmune Therapeutics, GeoVax Labs, Pieris Pharmaceuticals, Enzolytics Inc., Seres Therapeutics, Tonix Pharmaceuticals Holding Corp., 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 8 companies. JAS is a member of the veterans Affairs Rheumatology Field Advisory Committee. JAS is the editor and the Director of the UAB Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis. JAS served as a member of 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 Criteria subcommittee. AMJ has received research support from Bristol Myers Squibb. JR, EC, and BN have no conflicts. Other authors (RT, SN, and TRM) declare no relevant conflicts. There are no non-financial competing interests for any of the other authors.