Background/Purpose: The ACR recommends a treat-to-target strategy in gout management, centered on the titration of urate lowering therapy (ULT) to a goal serum urate (SU) of < 6.0mg/dL. However, there is a paucity of data regarding improvements in health-related quality of life (HRQoL) when receiving a treat-to-target regimen for gout management. Using data from the recently completed multicenter, randomized, double-blind, STOP Gout Study (O’Dell JR et al. NEJM Evidence 2022), we examined changes in HRQoL accompanying ULT administered as part of a treat-to-target strategy.

Methods: Participants with gout and SU concentration ≥6.8 mg/dL were randomized 1:1 to receive allopurinol or febuxostat. ULT was titrated during weeks 0-24 (Phase 1) and maintained during weeks 25-48 (Phase 2), with escalation as necessary, to reach goal SU of < 6.0 mg/dL. Participants were observed on a stable ULT dose during weeks 49-72 (Phase 3). For this analysis, participants were considered non-responders to ULT (either allopurinol or febuxostat based on randomization) if they did not achieve a goal SU of < 6.0mg/dL in Phase 2 (mean levels at weeks 36, 42 and 48) despite maximal ULT dosing. The EQ-5D-3L and VR-12 (a Veteran’s Administration HRQoL outcome based of the SF-12) questionnaires were collected and compared at baseline, 24 weeks, and 48 weeks and differences were examined over these time points using a repeated measures ANOVA. Baseline HRQoL values were compared by responder status using a t-test. Associations of SU change between baseline and 48 weeks, and SU goal achievement at 48 weeks with change in HRQoL outcomes were examined using linear regression models.

Results: Of the 940 trial participants, 764 had SU response data available at week 48 and were included in this analysis; 618 (80.9%) of these achieved a target SU goal < 6.0 mg/dl. Participants deemed non-responders at 48 weeks reported lower HRQoL scores at baseline when compared to responders (p< 0.001). Improvements in both measures were similar between allopurinol and febuxostat treatment arms (p >0.7 for both HRQoL measures). From baseline to 48 weeks both EQ-5D-3L and VR-12 questionnaire scores improved significantly in all participants (p< 0.0001) (Table 1). Neither SU change nor responder status (achievement of SU goal) at 48 weeks were associated with changes in HRQoL (Table 2).

Conclusion: In this secondary analysis from a large, randomized double-blind, non-inferiority trial comparing the efficacy and safety of allopurinol and febuxostat in the management of gout, we have found that HRQoL outcome measures improved with treat-to-target ULT. Over this period of observation, SU change achieved was not associated with HRQoL improvement, suggesting that a longer follow up period may be needed to identify these associations and/or that HRQoL improvements may be more closely tied with other gout outcomes such as recurrent flare. Regardless, these findings demonstrate that patients receiving treat-to-target ULT experience significant HRQoL gains even early in the course of management, supporting current ACR practice guidelines.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/health-related-quality-of-life-improvements-resulting-from-a-treat-to-target-strategy-in-the-management-of-gout-post-hoc-analysis-of-a-multicenter-randomized-double-blind-non-inferiority-trial/