Characteristic | Pegloticase Biweekly, n = 85 | Pegloticase Monthly, n = 84 | Placebo, n = 43 |
---|---|---|---|
Demographics | |||
Age, mean yrs | 56.3 | 54.5 | 55.4 |
Male sex, n (%) | 68 (80) | 69 (82) | 36 (84) |
White race/ethnicity, n (%) | 54 (64) | 59 (70) | 30 (70) |
Body mass index, mean kg/m2 | 33 | 33 | 32 |
Allopurinol | |||
Contraindication, n (%) | 69 (81) | 67 (80) | 38 (88) |
Ineffective, n (%) | 16 (19) | 17 (20) | 5 (12) |
Gout-related characteristics | |||
Duration, mean yrs | 15 | 16 | 13 |
Acute flares in prior 12 mo, mean* | 6.5 | 6.4 | 6.8 |
Baseline tophi present, n (%) | 62 (73) | 64 (76) | 29 (67) |
Chronic synovitis or arthropathy, n (%) | 50 (59) | 47 (56) | 26 (61) |
HAQ-DI, mean | 1.10 | 1.21 | 1.24 |
Plasma uric acid, mean, mg/dl | 9.8 | 9.9 | 9.2 |
Baseline comorbid conditions, n (%) | |||
One or more cardiovascular conditions or risk factors** | 72 (85) | 71 (85) | 35 (81) |
Hypertension | 62 (73) | 60 (74) | 31 (72) |
Dyslipidemia | 42 (49) | 41 (49) | 20 (46) |
Diabetes mellitus | 24 (38) | 18 (21) | 8 (19) |
Cardiac arrhythmia | 19 (22) | 8 (9) | 7 (16) |
Coronary artery disease | 14 (16) | 16 (19) | 9 (21) |
Cardiac failure/LVD | 12 (14) | 8 (9) | 6 (14) |
Peripheral vascular disease | 7 (8) | 6 (7) | 3 (7) |
Cerebrovascular disease | 4 (5) | 3 (4) | 1 (2) |
Obesity, BMI ≥ 30 kg/m2 | 50 (59) | 55 (65) | 24 (59) |
Osteoarthritis | 29 (34) | 23 (27) | 16 (37) |
Chronic kidney disease*** | 26 (30) | 25 (30) | 9 (21) |
Sleep apnea | 8 (9) | 9 (11) | 6 (14) |
Venous thromboembolic disease | 3 (3) | 2 (2) | 2 (5) |
↵* Self-reported.
↵** Includes any of the following: hypertension, dyslipidemia, diabetes, cardiac arrhythmias, coronary artery disease, cardiac failure, left ventricular dysfunction, peripheral vascular disease, or cerebrovascular disease.
↵*** Chronic kidney disease was defined as creatinine clearance < 60 ml/min calculated with the Cockcroft-Gault formula29. BMI: body mass index; LVD: left ventricular dysfunction; HAQ-DI: Health Assessment Questionnaire Disability Index.