Table 1.

Baseline characteristics of the pooled population from the 2 randomized controlled trials.

CharacteristicPegloticase Biweekly, n = 85Pegloticase Monthly, n = 84Placebo, n = 43
Demographics
  Age, mean yrs56.354.555.4
  Male sex, n (%)68 (80)69 (82)36 (84)
  White race/ethnicity, n (%)54 (64)59 (70)30 (70)
  Body mass index, mean kg/m2333332
Allopurinol
  Contraindication, n (%)69 (81)67 (80)38 (88)
  Ineffective, n (%)16 (19)17 (20)5 (12)
Gout-related characteristics
  Duration, mean yrs151613
  Acute flares in prior 12 mo, mean*6.56.46.8
  Baseline tophi present, n (%)62 (73)64 (76)29 (67)
  Chronic synovitis or arthropathy, n (%)50 (59)47 (56)26 (61)
  HAQ-DI, mean1.101.211.24
  Plasma uric acid, mean, mg/dl9.89.99.2
Baseline comorbid conditions, n (%)
  One or more cardiovascular conditions or risk factors**72 (85)71 (85)35 (81)
    Hypertension62 (73)60 (74)31 (72)
    Dyslipidemia42 (49)41 (49)20 (46)
    Diabetes mellitus24 (38)18 (21)8 (19)
    Cardiac arrhythmia19 (22)8 (9)7 (16)
    Coronary artery disease14 (16)16 (19)9 (21)
    Cardiac failure/LVD12 (14)8 (9)6 (14)
    Peripheral vascular disease7 (8)6 (7)3 (7)
    Cerebrovascular disease4 (5)3 (4)1 (2)
  Obesity, BMI ≥ 30 kg/m250 (59)55 (65)24 (59)
  Osteoarthritis29 (34)23 (27)16 (37)
  Chronic kidney disease***26 (30)25 (30)9 (21)
  Sleep apnea8 (9)9 (11)6 (14)
  Venous thromboembolic disease3 (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.