Area under the plasma uric acid curves from the first study drug dose through 96 h (AUC0-96 mg/dL · hr)
Patient group number of patients (rasburicase: allopurinol) . | Rasburicase mean AUC ± SD . | Allopurinol mean AUC ± SD . | Pvalues† . | AUC ratios‡ (95% CI)2-154 . |
---|---|---|---|---|
Total patients (27:25) | 128 ± 70 | 329 ± 129 | < .0001 | 2.6 (2.0-3.4) |
Leukemia (20:19) | 141 ± 75 | 361 ± 129 | < .0001 | 2.6 (1.9-3.5) |
Lymphoma (7:6) | 92 ± 41 | 224 ± 55 | .005 | 2.4 (1.6-4.0) |
Hyperuricemic (10:9) | 162 ± 87 | 440 ± 121 | .0007 | 2.7 (1.9-4.4) |
Normouricemic (17:16) | 108 ± 51 | 266 ± 85 | < .0001 | 2.5 (1.9-3.3) |
Burkitt*(5:4) | 90 ± 42 | 348 ± 200 | .02 | 3.9 (1.2-9.0) |
Patient group number of patients (rasburicase: allopurinol) . | Rasburicase mean AUC ± SD . | Allopurinol mean AUC ± SD . | Pvalues† . | AUC ratios‡ (95% CI)2-154 . |
---|---|---|---|---|
Total patients (27:25) | 128 ± 70 | 329 ± 129 | < .0001 | 2.6 (2.0-3.4) |
Leukemia (20:19) | 141 ± 75 | 361 ± 129 | < .0001 | 2.6 (1.9-3.5) |
Lymphoma (7:6) | 92 ± 41 | 224 ± 55 | .005 | 2.4 (1.6-4.0) |
Hyperuricemic (10:9) | 162 ± 87 | 440 ± 121 | .0007 | 2.7 (1.9-4.4) |
Normouricemic (17:16) | 108 ± 51 | 266 ± 85 | < .0001 | 2.5 (1.9-3.3) |
Burkitt*(5:4) | 90 ± 42 | 348 ± 200 | .02 | 3.9 (1.2-9.0) |
Burkitt includes children with mature B-cell leukemia, or ≥ stage III Burkitt lymphoma, or ≥ stage III small noncleaved-cell lymphoma.
The two mean AUCs were compared by two-sided Wilcoxon two-sample tests.
Allopurinol mean AUC/rasburicase mean AUC = mean fold decrease in uric acid exposure for patients receiving rasburicase.
95% confidence intervals on the ratios of the two mean uric acid AUC (0-96 h) using the Fieller theorem.19