Urate-lowering therapy (ULT) is part of the routine care of patients with gout. According to the mainland gout diagnosis and treatment standards, the goal of uric acid-lowering therapy for gout patients is blood uric acid (SU) <360μmol/L, and long-term maintenance; If the patient has already developed tophi, chronic gouty arthritis, or frequent attacks of gouty arthritis, the goal of uric acid-lowering therapy is SU<300 μmol/L, until the tophi is completely dissolved and the symptoms of frequent arthritis attacks improve, the treatment goal can be changed to SU<360 μmol/L, and maintained for a long time.
At present, target treatment is the best management strategy for gout, and further clarification of efficacy predictors can help to judge the benefit of patients and optimize the treatment plan. Based on this, a post-hoc analysis was carried out by foreign scholars to analyze the decisive factors affecting the achievement of ULT treatment in gout patients. The findings were recently published in the journal Arthritis Rheumatol. (Impact Factor: 6.9).
Study design
The STOP Gout Trial (NCT02579096) is a multicenter, randomized, double-blind, efficacy clinical trial comparing febuxostat and allopurinol, and this study is a post-hoc analysis of this large clinical trial divided into three phases: Phase 1 (0-24w), Phase 2 (25-48w), and Phase III (49-72w).
Patients with a SU ≥ 6.8 mg/dl who met the 2015 ACR gout classification criteria were randomized to allopurinol or febuxostat and dose-titrated at weeks 0-24 and maintenance doses at 25-48 weeks.
The SU target is considered to be met if the participant has a mean SU <of 6.0 mg/dl or < 5 mg/dl at weeks 36, 42, and 48 if is present.
Pre-selection of possible determinants of treatment response, including sociodemographics, comorbidities, diuretic use, health-related quality of life (HRQoL), body mass index, and gout measurement.
The primary outcome was achievement during Phase II.
Findings:
Of the 764 patients included in the analysis, 98% were male, with a mean age of 62 years. At the time of enrollment, the mean serum uric acid was 8.6 mg/dl, the average duration of gout was nearly 10 years, 16% had tophi, and 38% of patients were in chronic kidney disease stage 3. Other common comorbidities included hypertension (77%), diabetes mellitus (34%), cardiovascular disease (27%), and obesity (68%, obesity: BMI ≥30 kg/m2).
1. The proportion of patients with SU in the allopurinol and febuxostat groups was similar
Of the participants, 618/764 (81%) had SU at stage II; Attainment patients were more likely to have no gout flare-up in stage 3 than non-compliant patients (62% vs. 49%; p=0.004）。 The allopurinol group (82.8%) and the nonbuxostat group (78.9%) achieved a similar proportion of SU targets (p=0.16).
Compared with patients who failed to meet the target after ULT treatment, the patients who met the target were older (mean age 63 vs. 59 years), more Caucasian (74% vs. 52%), had a higher EQ-5D-3L score (indicating a better health-related quality of life (HRQoL) (0.7 vs. 0.6), had lower gout severity (i.e., lower SU concentration at enrollment (mean 8.4 mg/dl vs. 9.1 mg/dl), and had a lower proportion of patients with tophi (13% vs. 28% ), and the duration of the disease was shorter (mean 9.4 years vs. 11.3 years) (Table 1).
Table 1 Baseline characteristics of the attainment and non-compliance groups in the second stage
注：SD，标准差；BMI，身体质量指数；EQ-5D-3L，EuroQol 5维3级；SU：血清尿酸；SU目标< 6mg /dl或< 5mg /dl（如果有痛风石）
2. Factors affecting the achievement of SU: age, education level, HRQoL, diuretics, and severity of the disease
In multivariate analysis, baseline characteristics of patients with higher attainment rates included older age (aOR 1.04: 95% CI 1.02, 1.07/year), higher education (aOR 2.02: 95% CI 1.10, 3.69: relative to high school education or less), and better HRQoL (aOR 1.17: 95% CI 1.07, 1.29/0.1 units EQ-5D-3L). Characteristics associated with lower compliance rates included higher SU concentrations at enrollment (aOR 0.83: 95% CI 0.72, 0.96/1 mg/dl), presence of tophi (aOR 0.29: 95% CI 0.17, 0.49), and use of diuretics (aOR 0.52: 95% CI 0.32, 0.87) (Figure 1). The multivariate model showed good discriminant power (C statistic 0.76). Comorbidities including chronic kidney disease, hypertension, diabetes mellitus, and cardiovascular disease are not relevant to the achievement of SU targets. In addition, in analyses that considered adherence, there was no significant change in the results.
Fig.1 Forest diagram of baseline factors influencing SU attainment
Conclusions of the study
The study showed that baseline factors that predicted SU achievement included sociodemographic factors, health-related quality of life, diuretics, and gout severity; Common comorbidities of gout, such as chronic kidney disease, diabetes, hypertension, obesity, and cardiovascular disease, are not associated with SU attainment.
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参考文献：Helget LN, O'Dell JR, Newcomb JA, et al. Determinants of Achieving Serum Urate Goal with Treat-to-Target Urate-Lowering Therapy in Gout. Arthritis Rheumatol. 2024 Apr; 76(4):638-646. doi: 10.1002/art.42731.
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