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Pooled efficacy data from 3 studies
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Data from Study 1, 2, and 3 (n=265) were pooled and analyzed according to the plasma uric acid levels over time1
- 93% (246/265) of patients (pooled) enrolled in these clinical trials were pediatric1
- 98% (261/265) of enrolled patients were evaluable: 77% (200/261) of patients were nonhyperuricemic (<8 mg/dL) at baseline and 23% (61/261) of patients were hyperuricemic (≥8 mg/dL) at baseline1
In 3 clinical trials, ELITEK® (rasburicase) IV Infusion maintained normal uric acid levels in 100% of evaluable patients by Day 41
Evaluable patients maintaining normal uric acid levels (≤6.5 mg/dL for patients <13 years of age or ≤7.5 mg/dL for patients ≥13 years of age) 4 days post-initiation of ELITEK1
- Of the 261 evaluable patients in Study 1, 2, and 3 (pooled)1:
- Normal uric acid levels were maintained by 92% (240/261) of patients after 4 hours, 93% (245/261) after 24 hours, 97% (254/261) after 48 hours, and 99% (260/261) after 72 hours
- For patients with hyperuricemia (≥8 mg/dL) at baseline (61/261), uric acid levels were maintained by 72% (44/61) after 4 hours, 80% (49/61) after 24 hours, 92% (56/61) after 48 hours, and 98% (60/61) after 72 hours
- Maintenance was defined as uric acid levels ≤6.5 mg/dL (patients <13 years of age) or ≤7.5 mg/dL (patients ≥13 years of age) without the need for allopurinol or other agents1
In Study 1, pediatric patients receiving ELITEK experienced a more rapid decline vs allopurinol (P<0.0001) and maintained normal uric acid levels throughout treatment1,2
Mean (± SE) plasma uric acid concentrations over time for all patients2
Primary endpoint
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The uric acid AUC0-96 hr was significantly lower in the ELITEK group (128 ± SE 14 mg hr/dL) vs the allopurinol group (328 ± SE 26 mg hr/dL)1
All but 1 patient in the ELITEK arm had reduction and maintenance of uric acid levels to within or below the normal range during the treatment.1
The incidence of renal dysfunction was similar in the 2 study arms; 1 patient in the allopurinol arm developed acute renal failure.1
The recommended dose of ELITEK is 0.2 mg/kg as a 30-minute IV infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than 1 course is not recommended.1
In Study 2, ELITEK maintained normal uric acid levels in 99% of patients receiving 0.15 mg/kg/day by Day 21
Pediatric patients maintaining normal uric acid levels (≤6.5 mg/dL for patients <13 years of age or ≤7.5 mg/dL for patients ≥13 years of age) 2 days post-initiation of ELITEK without the need for allopurinol or other agents1
Primary endpoint
- The proportion of patients with maintenance of normal uric acid levels (≤6.5 mg/dL for patients <13 years of age or ≤7.5 mg/dL for patients ≥13 years of age) at 48 hours in Study 2 was 99% (106/107)1
The recommended dose of ELITEK is 0.2 mg/kg as a 30-minute IV infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than 1 course is not recommended.1
In Study 3, ELITEK maintained normal uric acid levels in 92% of patients receiving 0.15 mg/kg/day and 95% of patients receiving 0.2 mg/kg/day by Day 21
Pediatric patients maintaining normal uric acid levels (≤6.5 mg/dL for patients <13 years of age or ≤7.5 mg/dL for patients ≥13 years of age) 2 days post-initiation of ELITEK without the need for allopurinol or other agents1
Primary endpoint
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The proportion of patients with maintenance of normal uric acid levels (≤6.5 mg/dL for patients <13 years of age or ≤7.5 mg/dL for patients ≥13 years of age) at 48 hours in Study 3 was 92% in the 0.15 mg/kg group (n=12) and 95% in the 0.2 mg/kg group (n=119)1
The recommended dose of ELITEK is 0.2 mg/kg as a 30-minute IV infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than 1 course is not recommended.1
References: 1. ELITEK [prescribing information]. NJ: sanofi-aventis U.S. LLC. 2. Goldman SC, Holcenberg JS, Finklestein JZ, et al. A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis. Blood. 2001;97:2998-3003.
