SYMPHONY Results at 12 Months SYMPHONY Study Design






- Slides: 6

SYMPHONY: Results at 12 Months

SYMPHONY Study Design 150 -300 ng/ml for 3 months 100 -200 ng/ml thereafter A Normal dose Cs. A MMF Steroids 50– 100 ng/ml Daclizumab Low dose Cs. A MMF Steroids 3 -7 ng/ml Daclizumab Low dose TAC MMF Steroids 4 -8 ng/ml Daclizumab Low dose SRL MMF Steroids B C D Tx Adapted from Ekberg H. ATC 2007. 6 mo 12 mo

Renal Function-calculated GFR at month 12 (Cockcroft-Gault) ITT Normal-dose Cs. A GFR (ml/min) n median mean SD 390 57. 1 25. 1 p<0. 0001 Low-dose Cs. A 399 61. 0 59. 4 25. 1 Low-dose TAC 401 66. 2 65. 4 27. 0 p=0. 0011 p<0. 0001 Low-dose SRL Adapted from Ekberg H. ATC 2007. 399 57. 5 56. 7 26. 9

Probability of acute rejection Biopsy Proven Acute Rejection (ITT, Excluding Borderline) 0. 5 37. 2% Low-dose SRL 0. 3 25. 8% Normal-dose Cs. A 0. 2 24. 0% Low-dose Cs. A 0. 1 12. 3% Low-dose TAC 0. 4 0. 0 0 2 4 6 8 Time (months) Adapted from Ekberg H. ATC 2007. 10 12

Graft and Patient Survival p = NS p=0. 0143 p=0. 0147 93% 94% 90 89% 80 100 Patient survival (%) Graft survival (%) 100 96% 98% 97% 90 80 70 70 12 months post-Tx Normal-dose Cs. A Adapted from Ekberg H. ATC 2007. Low-dose Cs. A 12 months post-Tx Low-dose TAC Low-dose SRL

Results at 12 months post-Tx 100 90 80 70 60 50 40 30 20 10 0 P<0. 0001 57 59 50 P<0. 0001 40 P<0. 0001 65 57 Calculated GFR (Cockcroft-Gault) BPAR (% of patients) GFR (Cockcroft Gault) (ml/min) P=0. 0011 30 26% 37% 24% 20 12% 10 0 Biopsy Proven Acute Rejection (ITT, Excluding Borderline) Normal-dose Cs. A Low-dose Cs. A Adapted from Ekberg H. ATC 2007. Low-dose TAC Low-dose SRL
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12 Months 12 Brothers There are 12 months