SYMPHONY: Results at 12 Months
N
Kidney
function
(Mean GFR
mL/min)
Acute rejection
Graft
Patient
(BPAR, %) survival (%) survival (%)
Normal-dose
cyclosporine
390
57.1*
25.8*
89†
96¶
Low-dose
cyclosporine
399
59.4**
24.0*
93¶
98¶
Low-dose tacrolimus 401
65.4
12.3
94
97¶
Low-dose sirolimus
56.7*
37.2*
89‡
97¶
399
†
‡
Low-dose tacrolimus vs. other regimens: *P<0.0001, **P<0.0011, P<0.0143, P<0.0147
non-significant
Adapted from Ekberg H. ATC 2007.
SYMPHONY Study Design
150-300 ng/ml for 3 months
100-200 ng/ml thereafter
A
Normal dose CsA
MMF
Steroids
50–100 ng/ml
Daclizumab
Low dose CsA
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 CsA
GFR (ml/min)
n
median
mean
SD
390
57.0
57.1
25.1
p<0.0001
Low-dose CsA
399
61.0
59.4
25.1
p=0.0011
Low-dose TAC
401
66.2
65.4
27.0
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 CsA
0.2
24.0%
Low-dose CsA
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
96%
93% 94%
89%
90
100
89%
80
Patient survival (%)
Graft survival (%)
100
98% 97%
97%
90
80
70
70
12 months post-Tx
Normal-dose CsA
Adapted from Ekberg H. ATC 2007.
Low-dose CsA
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
P<0.0001
65
57
BPAR (% of patients)
GFR (Cockcroft Gault) (ml/min)
P=0.0011
30
26%
37%
24%
20
12%
10
0
Calculated GFR
(Cockcroft-Gault)
Biopsy Proven Acute
Rejection
(ITT, Excluding Borderline)
Normal-dose CsA
Low-dose CsA
Adapted from Ekberg H. ATC 2007.
Low-dose TAC
Low-dose SRL