Biweekly intravenous pegloticase therapy significantly improved pain, physical function and health-related quality of life in patients with refractory chronic gout in a recent study.
Researchers enrolled 212 patients (mean age, 55.4 years; 81.6% men) with refractory chronic gout (RCG) for two replicate 6-month, randomized controlled phase 3 trials. Patients had mean serum uric acid levels of 9.7 mg/dL, a mean of 9.8 flares in the preceding 18 months and were assigned to three groups. Patients received intravenous 8 mg pegloticase twice monthly (biweekly group, n=85), 8 mg pegloticase alternating with placebo (monthly group, n=84), or placebo (n=43).
Patients also completed Medical Outcomes Study Short Form-36 (SF-36), Health Assessment Questionnaire-Disability Index (HAQ-DI), patient global assessment of disease activity (PtGA), and pain by visual analog scale at baseline, weeks 12, 19, and 25. At the endpoint researchers combined values for all treatment groups from prespecified pooled analyses of patient-reported outcomes. One hundred fifty-seven patients completed treatment.
Baseline SF-36 physical component scores (PCS) were greater than 1.5 SD below US normative value (50) for the biweekly (35.2), monthly (33.3) and placebo (31.0) groups. At week 25 researchers found the mean changes from baseline in PtGA, HAQ-DI, pain, and PCS scores to be statistically significant, exceeding minimum clinically important differences (MCID) in the biweekly group compared with little to no improvement in the placebo group.
Statistically significant improvements greater than or equal to MCID also were reported in six of eight SF-36 domains (all P<.05) for the biweekly cohort, while the monthly pegloticase group showed significantly improved PtGA, HAQ-DI, PCS, and three SF-36 domains (all P<.05).
“Treatment with the FDA-approved schedule of biweekly pegloticase results in statistically significant and clinically meaningful improvements in pain, global assessment of disease activity, physical function, and [health-related quality of life] in patients with RCG,” investigators concluded.