symphony: results at 12 months. daclizumab low dose csa mmf steroids b 50–100 ng/ml low dose srl d...
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SYMPHONY: Results at 12 Months
N
Kidney function
(Mean GFR mL/min)
Acute rejection
(BPAR, %)
Graft
survival (%)
Patient
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 399 56.7* 37.2* 89‡ 97¶
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.
DaclizumabLow dose CsAMMFSteroids
B50–100 ng/ml
Low dose SRLD MMF
Steroids
Daclizumab4-8 ng/ml
Low dose TACMMFSteroids
Daclizumab3-7 ng/ml
C
150-300 ng/ml for 3 months100-200 ng/ml thereafter
Normal dose CsAMMFSteroids
A
SYMPHONY Study Design
Tx 6 mo 12 mo
Adapted from Ekberg H. ATC 2007.
Renal Function-calculated GFR at month 12 (Cockcroft-Gault)
ITTITT GFR (ml/min)GFR (ml/min)
nn medianmedian meanmean SDSD
Normal-dose CsANormal-dose CsA 390390 57.057.0 57.157.1 25.1 25.1
Low-dose CsALow-dose CsA 399399 61.061.0 59.459.4 25.125.1
Low-dose TACLow-dose TAC 401401 66.266.2 65.465.4 27.027.0
Low-dose SRLLow-dose SRL 399399 57.557.5 56.756.7 26.926.9
p<0.0001
p=0.0011
p<0.0001
Adapted from Ekberg H. ATC 2007.
Biopsy Proven Acute Rejection (ITT, Excluding Borderline)P
roba
bilit
y of
acu
te r
ejec
tion
Time (months)
25.8% Normal-dose CsA
24.0% Low-dose CsA
12.3% Low-dose TAC
37.2% Low-dose SRL
0.5
0.4
0.3
0.2
0.1
0.0
0 2 4 6 8 10 12
Adapted from Ekberg H. ATC 2007.
Graft and Patient Survival
p=0.0147p=0.0143
89%
93% 94%
89%
70
80
90
100
12 months post-Tx
Gra
ft s
urvi
val (
%)
70
80
90
100
12 months post-Tx
Pat
ient
sur
viva
l (%
)
p = NS
96%98% 97% 97%
Low-dose TAC Low-dose SRLNormal-dose CsA Low-dose CsA
Adapted from Ekberg H. ATC 2007.
Results at 12 months post-Tx
Calculated GFR(Cockcroft-Gault)
0102030405060708090
100
GF
R (
Co
ckc
roft
Gau
lt)
(ml/m
in)
P<0.0001
P=0.0011
P<0.0001
57 5965
57
Biopsy Proven Acute Rejection
(ITT, Excluding Borderline)
26%24%
12%
37%
P<0.0001
P<0.0001
0
10
20
30
40
50
BP
AR
(%
of
pat
ien
ts)
Low-dose TAC Low-dose SRLNormal-dose CsA Low-dose CsA
Adapted from Ekberg H. ATC 2007.