Variable | C/DE (n = 93) | DE/DE (n = 90) | P valuesa | ||||
---|---|---|---|---|---|---|---|
CrCL <30 ml/min (n = 14) | CrCL ≥30 to <60 ml/min (n = 31) | CrCL ≥60 ml/min (n = 48) | CrCL <30 ml/min (n = 10) | CrCL ≥30 to<60 ml/min (n = 40) | CrCL ≥60 ml/min (n = 40) | ||
Change in serum urate (mg/dl), mean (SE) | |||||||
Baseline to month 12 | -0.67 (0.67) | -0.05 (0.33) | -0.25 (0.26) | -1.49 (0.47) | -2.27 (0.29) | -1.06 (0.24) | 0.04 |
Baseline to month 24 | -2.23 (0.88) | -1.41 (0.36) | -1.10 (0.25) | -2.47 (0.68) | -2.35 (0.28) | -0.86 (0.27) | 0.15 |
Month 12 to month 24 | -1.42 (0.45) | -1.51 (0.41) | -0.87 (0.25) | -1.20 (0.29) | 0.01 (0.17) | 0.34 (0.23) | 0.82 |
Serum urate <6 mg/dl, % | |||||||
Month 12 | 13% | 25% | 49% | 57% | 86% | 86% | 0.50 |
Month 24 | 57% | 68% | 72% | 71% | 82% | 79% | 0.93 |
Mean (SE) serum urate | |||||||
Baseline | 8.25 (0.41) | 7.10 (0.29) | 6.82 (0.21) | 8.02 (0.46) | 7.63 (0.26) | 6.52 (0.20) | <0.001b |
Month 12 | 7.38 (0.57) | 7.13 (0.32) | 6.37 (0.24) | 5.91 (0.59) | 5.25 (0.12) | 5.34 (0.19) | 0.20 |
Month 24 | 5.93 (0.71) | 5.72 (0.25) | 5.62 (0.19) | 5.21 (0.30) | 5.27 (0.18) | 5.61 (0.25) | 0.46 |
Percentage change in serum urate from baseline, mean (SE) | |||||||
Baseline to month 12 | -6.2 (7.2) | 1.6 (4.9) | -1.9 (3.4) | -20.2 (6.0) | -27.5 (2.9) | -15.0 (3.5) | 0.08 |
Baseline to month 24 | -25.5 (8.5) | -16.6 (4.8) | -13.9 (3.2) | -30.0 (5.8) | -29.1 (2.8) | -11.8 (4.1) | 0.14 |
Month 12 to month 24 | -19.4 (5.4) | -17.9 (4.6) | -10.1 (3.5) | -2.4 (5.4) | 0.87 (3.2) | 7.75 (4.6) | 0.99 |
Percentage with at least one flare in preceding month | |||||||
Baseline | 50% | 38.7% | 56.3% | 40.0% | 32.5% | 42.5% | 0.17b |
Month 12 | 37.5% | 12.5% | 39% | 14.3% | 34.3% | 32.1% | 0.10 |
Month 24 | 14.3% | 13.6% | 20.5% | 0.0% | 15.2% | 3.4% | 0.30 |
Allopurinol dose (mg/day) to achieve target SU at month 24, mean (range) | 262.5 (150–500) | 389.3 (250–650) | 439.3 (300–800) | 350.0 (250–600) | 396.3 (200–700) | 491.3 (300–900) | 0.002b |
Number of participants requiring >300 mg/day to achieve target SU at month 24 | 1/4 (25%) | 9/14 (64.3%) | 20/28 (71.4%) | 1/5 (20%) | 16/27 (59.3%) | 19/23 (82.6%) | 0.013 |
Percentage of individuals receiving anti-inflammatory prophylaxis | |||||||
Baseline | 35.7% | 48.4% | 52.1% | 40.0% | 60.0% | 57.5% | 0.30b |
Month 12 | 37.5% | 29.2% | 29.3% | 71.4% | 34.3% | 14.3% | 0.15 |
Month 24 | 14.3% | 18.2% | 15.4% | 57.1% | 9.1% | 10.3% | 0.16 |
HAQ mean (SE) change | |||||||
Baseline to month 12 | -0.10 (0.19) | 0.10 (0.15) | -0.14 (0.09) | 0.47 (0.28) | 0.06 (0.12) | -0.13 (0.11) | 0.25 |
Baseline to month 24 | -0.09 (0.21) | 0.14 (0.11) | -0.32 (0.07) | -0.19 (0.30) | -0.05 (0.11) | -0.20 (0.12) | 0.67 |
Month 12 to month 24 | 0.10 (0.04) | -0.09 (0.18) | -0.22 (0.08) | -0.72 (0.35) | -0.05 (0.13) | -0.05 (0.11) | 0.04 |
Pain VAS mean (SE) change | |||||||
Baseline to month 12 | -0.25 (0.90) | 1.04 (0.51) | -0.02 (0.40) | 0.43 (0.61) | 0.17 (0.40) | -0.43 (0.54) | 0.57 |
Baseline to month 24 | -1.15 (1.3) | 0.27 (0.62) | -1.10 (0.35) | -0.50 (1.36) | -0.64 (0.37) | -1.28 (0.53) | 0.56 |
Month 12 to month 24 | -0.71 (0.71) | -0.52 (0.84) | -1.03 (0.37) | -0.60 (0.87) | -0.67 (0.34) | -0.78 (0.57) | 0.93 |
SJC mean (SE) change | |||||||
Baseline to month 12 | -2.88 (1.84) | -0.04 (1.05) | -0.07 (0.72) | 0.86 (1.6) | -1.17 (0.89) | 0.17 (0.53) | 0.19 |
Baseline to month 24 | -2.14 (1.39) | -2.86 (1.65) | -1.26 (0.73) | -0.67 (0.67) | -1.85 (0.93) | -0.24 (0.27) | 0.99 |
Month 12 to month 24 | 1.23 (1.16) | -2.91 (2.24) | -1.34 (0.98) | 0 (0) | -0.52 (0.42) | -0.37 (0.59) | 0.57 |
TJC mean (SE) change | |||||||
Baseline to month 12 | 2.13 (3.56) | 0.04 (1.33) | -2.83 (1.07) | -0.57 (0.62) | -1.57 (0.90) | 1.18 (1.42) | 0.04 |
Baseline to month 24 | -2.57 (1.97) | -1.73 (1.49) | -2.08 (0.88) | -0.50 (0.34) | -0.42 (1.54) | -0.97 (0.50) | 0.97 |
Month 12 to month 24 | -5.0 (3.0) | -2.57 (1.83) | 0.65 (0.55) | -0.20 (0.20) | 1.18 (1.32) | -1.96 (1.37) | 0.02 |