Angelo Gaffo, Md1, Bhavisha Desai, Pharm D2, Abiola Oladapo, Phd2, Nana Kragh, Msc3, Lauren A. Do, Ms4, Madeline O’grady, Ma4, Naomi Schlesinger, Md5
Affiliation(s):
1. division Of Rheumatology And Clinical Immunology, University Of Alabama, Birmingham, Al, USA;
2. Sobi Inc., Waltham, Ma, USA;
3. Sobi, Stockholm, Sweden;
4.stratevi, Boston, Ma, Usa; 5university Of Utah, Salt Lake, Ut, USA
Background: Uncontrolled gout (UG) is classified as elevated serum uric acid (sUA) levels and persistent symptoms despite treatment with urate lowering therapy.1,2 While the overall burden of UG is recognized, there is limited research addressing the impact of clinical symptoms on health-related quality of life (HRQOL) and daily functioning.
Objectives: To evaluate the impact of elevated sUA levels or tophi on HRQOL and daily functioning in patients with UG.
Methods: A cross-sectional web-based survey was conducted among patients with a physician-confirmed diagnosis of UG, defined as adults (≥18 years) with a history of symptomatic gout (≥2 gout flares within 12 months or presence of ≥1 gout tophus, or current diagnosis of symptomatic chronic gouty arthritis) and currently taking oral urate-lowering therapy or treated with pegloticase in the past 18 months.
Collected data included demographics, clinical characteristics, treatment details, and patientreported outcomes (activities of daily living [ADLs], 12-item Short Form Survey [SF12v2], Work Productivity and Activity Impairment [WPAI]). ADL burden was rated on a fivepoint Likert scale (i.e., not at all, a little bit, somewhat, quite a bit, very much).
The SF12v2 questionnaire (0-100; higher values indicting better HRQOL) assesses physical and mental HRQOL. WPAI scores (0–100%) reflect impairment, where higher values indicate greater impact. Two separate subgroup analyses were conducted: 1) history of tophi (history vs no history of tophi) and 2) the most recent sUA level (≥6 mg/dL vs <6 mg/dL). Unadjusted differences between subgroups were tested using Wilcoxon rank-sum tests for continuous variables and chi-square or Fisher’s exact tests for categorical variables.
Results: Among the 100 patients included in the tophi analysis, 35% had a history of tophi. The mean age was 56.7 years (standard deviation [SD]=13.8) for those with tophi and 53.0 years (SD=12.8) for those with no history. The majority were male (62.9% vs. 63.1%) and White (42.9% vs 49.2%). Across the SF-12v2 subdomains, patients with tophi history reported lower general health (mean 35.2 vs 39.7; p=.044) and mental health (39.8 vs 43.9; p=.050) scores than those without tophi. Patients with tophi experienced greater emotional burden, with more reporting that UG impacts feelings of frustration (34.3% vs 16.9%; p=.004) and irritability (45.7% vs 24.6%; p=.002). Differences in WPAI measures were not statistically significant between both subgroups. The sUA analysis included 94 patients, the majority of whom (76.6%) had sUA levels ≥6 mg/dL. The mean age was 53.4 years (SD=14.0) and 59.6 years (SD=9.0) for those with sUA ≥6 mg/dl and <6 mg/dl, respectively. The majority were male (66.7% vs 54.6%) and White (47.2% vs 54.6%). Patients with sUA ≥6 mg/dL experienced significantly higher rates of gout flares (83.3% vs 59.1%; p=.017) and lower scores across the SF-12v2 physical (36.0 vs 39.8; p=.008) and mental (41.5 vs 47.3; p=.009) health domains. Those with sUA ≥6 mg/dL experienced greater emotional burden, reporting increased frustration (26.4% vs 13.6%; p=.013) and irritability (40.3% vs 9.1%; p=.002) associated with UG. Patients with sUA ≥6 mg/dL also showed greater impairment in work productivity (58.3% vs 40.8%; p=.073) and ability to perform daily activities (64.3% vs 51.4%; p=.017).
Conclusion: Despite treatment with ULTs, patients with UG experience reduced HRQOL and greater work/activity impairment, worsened by tophi or high sUA, highlighting the need for personalized, escalated therapy.
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