Table 1.
Demographic and baseline disease characteristics (intent-to-treat population)
| ALLO alone (n=206) | Lesinurad 200 mg+ALLO (n=204) | Lesinurad 400 mg+ALLO (n=200) | Total (n=610) | |
|---|---|---|---|---|
| Sex (n (%)) | ||||
| Male | 196 (95.1) | 197 (96.6) | 194 (97.0) | 587 (96.2) |
| Female | 10 (4.9) | 7 (3.4) | 6 (3.0) | 23 (3.8) |
| Race (n (%)) | ||||
| White | 155 (75.2) | 167 (81.9) | 160 (80.0) | 482 (79.0) |
| Black or African-American | 22 (10.7) | 15 (7.4) | 21 (10.5) | 58 (9.5) |
| Asian | 14 (6.8) | 10 (4.9) | 9 (4.5) | 33 (5.4) |
| Native Hawaiian or other Pacific Islander | 5 (2.4) | 3 (1.5) | 2 (1.0) | 10 (1.6) |
| American-Indian or Alaska Native | 1 (0.5) | 1 (0.5) | 0 | 2 (0.3) |
| Other | 8 (3.9) | 4 (2.0) | 6 (3.0) | 18 (3.0) |
| Missing | 0 | 0 | 1 (0.5) | 1 (0.2) |
| Age (years) | ||||
| Mean (SD) | 51.4 (10.56) | 51.0 (11.11) | 51.3 (11.08) | 51.2 (10.90) |
| Min, max | 21, 80 | 21, 82 | 18, 80 | 18, 82 |
| BMI (kg/m2) | ||||
| Mean (SD) | 33.87 (6.19) | 34.67 (6.43) | 33.81 (6.68) | 34.12 (6.44) |
| Min, max | 21.91, 56.27 | 22.55, 55.63 | 22.76, 69.36 | 21.91, 69.36 |
| Duration since gout diagnosis (years) | ||||
| Mean (SD) | 11.31 (9.38) | 12.25 (9.75) | 11.02 (8.59) | 11.53 (9.26) |
| Min, max | 0.2, 53.0 | 0.5, 45.0 | 0.0, 47.4 | 0.0, 53.0 |
| Presence of tophi at screening (n (%)) | ||||
| Yes | 48 (23.3) | 49 (24.0) | 47 (23.5) | 144 (23.6) |
| No | 158 (76.7) | 155 (76.0) | 153 (76.5) | 466 (76.4) |
| Presence of ≥1 target tophus at baseline (n (%)) | ||||
| Yes | 33 (16.0) | 35 (17.2) | 29 (14.5) | 97 (15.9) |
| No | 173 (84.0) | 169 (82.8) | 171 (85.5) | 513 (84.1) |
| No. of target tophi at baseline | ||||
| n | 33 | 35 | 29 | 97 |
| Mean (SD) | 2.2 (1.36) | 2.0 (1.34) | 2.5 (1.53) | 2.2 (1.40) |
| Min, max | 1, 5 | 1, 5 | 1, 5 | 1, 5 |
| No. of gout flares in the past 12 months | ||||
| Mean (SD) | 5.8 (4.92) | 6.7 (7.01) | 6.1 (5.65) | 6.2 (5.93) |
| Min, max | 2, 30 | 2, 50 | 2, 48 | 2, 50 |
| Renal function at baseline (mL/min) (n (%)) | ||||
| eCrCl ≥90 | 72 (35.0) | 80 (39.2) | 85 (42.5) | 237 (38.9) |
| eCrCl <90 | 133 (64.6) | 124 (60.8) | 114 (57.0) | 371 (60.8) |
| eCrCl ≥60 | 165 (80.1) | 175 (85.8) | 170 (85.0) | 510 (83.6) |
| eCrCl <60 | 40 (19.4) | 29 (14.2) | 29 (14.5) | 98 (16.1) |
| CV risk factors (n (%)) | ||||
| Hypertension | 141 (68.4) | 131 (64.2) | 121 (60.5) | 393 (64.4) |
| Hyperlipidaemia | 76 (36.9) | 86 (42.2) | 93 (46.5) | 255 (41.8) |
| Type 2 diabetes | 28 (13.6) | 31 (15.2) | 26 (13.0) | 85 (13.9) |
| History of kidney stones (n (%)) | 28 (13.6) | 23 (11.3) | 18 (9.0) | 69 (11.3) |
| Baseline thiazide/thiazide-like diuretic use (n (%)) | 37 (18.0) | 43 (21.1) | 35 (17.5) | 115 (18.9) |
| sUA at baseline (mg/dL) (µmol/L) | ||||
| Mean (SD) | 7.0 (1.3) (416 (75)) | 6.8 (1.1) (407 (66)) | 6.9 (1.2) (410 (71)) | 6.9 (1.2) (410 (71)) |
| Min, max | 3.4, 11.3 (202, 672) | 4.0, 11.3 (238, 672) | 3.8, 11.0 (226, 654) | 3.4, 11.3 (202, 672) |
| sUA category at baseline (n (%)) | ||||
| <8.0 mg/dL (<476 µmol/L) | 162 (78.6) | 177 (86.8) | 164 (82.0) | 503 (82.5) |
| ≥8.0 mg/dL (≥476 µmol/L) | 44 (21.4) | 27 (13.2) | 36 (18.0) | 107 (17.5) |
| Type of gout flare prophylaxis at baseline (n (%)) | ||||
| Colchicine | 159 (77.2) | 181 (88.7) | 167 (83.5) | 507 (83.1) |
| NSAID | 51 (24.8) | 23 (11.3) | 36 (18.0) | 110 (18.0) |
| Both | 8 (3.9) | 4 (2.0) | 3 (1.5) | 15 (2.5) |
| Other or missing | 4 (1.9) | 4 (2.0) | 0 | 8 (1.3) |
| Allopurinol dose at baseline (mg/day) | ||||
| Mean (SD) | 308.7 (69.29) | 313.5 (78.33) | 314.8 (77.62) | 312.3 (75.08) |
| Min, max | 200, 600 | 200, 900 | 200, 900 | 200, 900 |
ALLO, allopurinol; BMI, body mass index; CV, cardiovascular; eCrCl, estimated creatinine clearance; NSAID, non-steroidal anti-inflammatory drug; sUA, serum uric acid.