What is the Best Induction Immunosuppression Regimen in Kidney Transplantation? Richard Borrows: Queen Elizabeth Hospital Birmingham
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1 What is the Best Induction Immunosuppression Regimen in Kidney Transplantation? Richard Borrows: Queen Elizabeth Hospital Birmingham
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3 SYMPHONY Study Ekberg et al. NEJM 2008
4 Excluded: DCD kidneys; CIT>30hours; PRA>20%; positive cross match; retransplantwhere 1 st graft lost to AR within first year All received MMF and steroid Basiliximab to all except standard dose Cyclosporine
5 SYMPHONY Study: Acute Rejection
6 SYMPHONY Study
7 SYMPHONY Study
8 SYMPHONY Study
9 SYMPHONY Study Anti CD25 mab Tacrolimus MMF Steroid
10
11 Alternative Induction Agents Alternative CNI or CNI avoidance MMF or AZA? Steroids or Steroid Avoidance?
12 1. Induction or no induction and which agent?
13 Anti CD25 mab induction meta analysis: acute rejection Adu et al. BMJ 2003
14 Anti CD25 mabinduction meta analysis: Graft Failure Adu et al. BMJ 2003
15 Another Anti CD25 mab induction meta analysis: 24 Studies Anti CD25mAb versus Placebo Death Censored Graft Failure at 1 year (24 studies) Reduced Overall Graft failure Reduced Death No difference Webster AC et al. Transplantation 2004; Webster AC et al. Cochrane Review 2010
16 Another Anti CD25 mab induction meta analysis: 24 Studies Anti CD25mAb versus Placebo Death Censored Graft Failure at 1 year (24 studies) Reduced Overall Graft failure Reduced Death No difference BPAR within 1 st year Reduced Malignancy within 6 months CMV disease within 1 st year Decreased Decreased Webster AC et al. Transplantation 2004; Webster AC et al. Cochrane Review 2010
17 Is there a further advantage with ALG induction over anti CD25 mab: meta analysis ALG versus Anti CD25mAb in allcomers BPAR within 1 st year 30% reduction Death Censored Graft Failure No difference Overall Graft failure No difference Death No difference Malignancy Increased CMV disease within 1 st year Increased Webster AC et al. Transplantation 2004; Webster AC et al. Cochrane Review 2010
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19 Anti CD25 versus ALG in High Immune Risk Settings: Noel et al. JASN 2009 Current PRA>30% Peak PRA>50% 2 nd Transplant with 1 st lost to Acute Rejection 3 rd or 4 th Transplant (Cytotoxic cross match negative) Thymoglobulin versus Daclizumab Tacrolimus MMF Steroid
20 Anti CD25 versus ALG in High Immune Risk Settings: Noel et al. JASN 2009
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22 Anti CD25 mabinduction meta analysis: Do we need it in low immune risk settings Anti CD25mAb versus placebo (11 studies) BPAR within 1 st year 32% reduction Death Censored Graft Failure No difference Overall Graft failure No difference Death No difference Malignancy No difference CMV disease within 1 st year No difference Webster AC et al. Cochrane Review 2010
23 Alemtuzumab( Campath ; anti CD52 mab) Morgan et al. Transplantation 2012
24 Alemtuzumab( Campath ) Morgan et al. Transplantation 2012
25 Alemtuzumab( Campath ) Morgan et al. Transplantation 2012
26 Alemtuzumab( Campath ) Morgan et al. Transplantation 2012
27 Alemtuzumab( Campath ) Morgan et al. Transplantation 2012
28 Alemtuzumab( Campath ) Morgan et al. Transplantation 2012
29 Alemtuzumab( Campath ) Morgan et al. Transplantation 2012
30 Alemtuzumab( Campath ) Morgan et al. Transplantation 2012
31 Alemtuzumab( Campath ) Morgan et al. Transplantation 2012
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33
34
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36
37
38 INTAC Study Hanawayet al. NEJM 2011
39 INTAC Study Excluded: ECD and DCD kidneys; CIT>36 hours; positive cross match; fully matched live donor First Transplant and Peak or Current PRA<20% and Not Black Race Not low risk!
40 INTAC Study Rejection Graft Failure Death
41 INTAC Study: Adverse Events
42 INTAC Study
43 INTAC Study Increased rates of late biopsyproven acute rejection: 8% vs 2% (p=0.03)
44 INTAC Study: Lymphocyte repopulation
45 Alemtuzumab compared with alternative contemporary induction regimens LaMattina et al. Transplant International 2012 UW experience Campath(n=632; ) Basiliximab(n=690; low risk ) ATG (n=125; high risk ) Campath vs Other Overall Graft Survival Decreased 1 st Deceased Donor Graft Survival Decreased Repeat Deceased Donor Graft Survival Decreased 1 st Live Donor Graft Survival Decreased Antibody Associated Rejection Increased Overall Infection Increased CMV infection Increased Death due to Infection Increased Patient Survival Same
46 Alemtuzumab compared with alternative contemporary induction regimens LaMattina et al. Transplant International 2012 UW experience Campath(n=632; ) Basiliximab(n=690; low risk ) ATG (n=125; high risk ) Campath vs Other Overall Graft Survival Decreased 1 st Deceased Donor Graft Survival Decreased Repeat Deceased Donor Graft Survival Decreased 1 st Live Donor Graft Survival Decreased Antibody Associated Rejection Increased Overall Infection Increased CMV infection Increased Death due to Infection Increased Patient Survival Same
47 Rituximab(anti CD20 mab) Rituximab versus Daclizumab Tacrolimus; MMF; Induction MP only Clatworthy. NEJM 2009
48 Rituximab(anti CD20) Rituximab versus Placebo Tacrolimus; MMF; Steroid Transplantation 2009
49 2. Choice of CNI Tacrolimus versus Ciclosporin
50 Tacrolimus versus Ciclosporin meta analysis: Acute rejection Webster et al. BMJ 2005
51 Tacrolimus versus Ciclosporin meta analysis: Death censored graft failure
52 Tacrolimus versus Ciclosporin meta analysis: Death censored graft failure Meta-regression p=0.04
53 Tacrolimus versus Ciclosporin meta analysis: Death censored graft failure Meta-regression p=0.04
54 SYMPHONY Study
55 SYMPHONY Study vs vs
56 3. Can we avoid CNIsaltogether de novo?
57 CNI versus mtori meta analysis: Overall graft failure Sharif et al JASN 2011
58 CNI versus new agents meta analysis: Overall graft failure CP 690,550 Tazocitinib Belatacept Tofacitinib Sharif et al JASN 2011
59 4. Alternative adjunctive antimetabolites Azathioprine versus Mycophenolate
60 Meta analysis: Mycophenolate versus Azathioprine 3143 patients 19 studies CNI: Neoral or Tacrolimus MMF versus Azathioprine Transplantation 2009 MMF vs Azathioprine Acute Rejection Decreased (0.62[95%CI: ]) Overall Graft Failure Decreased (0.76[95%CI: ]) Mortality No difference Transplant Function No difference Infection No difference CMV No difference Anaemia No difference Leucopaemia No difference Malignancy No difference Diarrhoea Increased
61 5. Steroid avoidance
62 Steroid avoidance or withdrawal: a meta analysis 34 RCTs (n=5637 patients) Knight and Morris. Transplantation 2010 Acute Rejection
63
64 However... Hypercholesterolaemia NODAT
65 N=397 Exclusions Rejection or dialysis in first 7 days; n=5 (five!) Current PRA>25% CIT>36 hours 55% live donor Ann Surgery 2008
66 Early corticosteroid withdrawal (Day 7) versus 5mg prednisolone maintainance Woodleet al. Ann Surgery 2008 Biopsy confirmed Moderate/Severe Acute Rejection Graft Failure Death No difference No difference No difference
67 Metabolic complications through 5 years
68 Metabolic complications through 5 years Hypolipidaemic Agent commencement and ongoing therapy Lower (50% vs 67%; p=0.04) NODAT No difference (21.5 vs 21%) Insulin requirement Lower (3.7 vs 11.6%; p=0.05) Bone Complications Lower (5% vs 11%; p=0.04) Cataract No difference Weight Gain (median) Less (5.1 vs 7.7kg)
69
70 Acute rejection Biopsy confirmed Rejection For cause Biopsies Biopsiesshowing Chronic Allograft Nephropathy Increased Increased Increased Risk Factors for Graft Loss Acute Rejection RR: 5.0; 95% CI: ; p=0.003 CAN RR: 41; 95% CI: ; p<0.001
71 In Summary
72 So what is the best induction immunosuppression regimen? 1] Anti CD25 mab induction reduces rejection and graft failure 2] ATG and Campath further reduce rejection but not graft failure, and an increase in toxicity 3] The spectre of late rejection and antibody-associated rejection remains with Campath 4] Further data on Rituximab required 5] Tacrolimus reduces rejection compared with Ciclosporin 6] This may not translate into a clinically relevant reduction in graft survival in low dose setting 7] CNI avoidance with mtori is fraught 8] Newer Agents improve graft survival and may herald breakthrough of true CNI avoidance 9] MMF reduces rejection and graft failure compared with Azathioprine 10] Steroid avoidance is associated with increased rates of rejection 11] Metabolic complications of 5mg prednisolone are slight / manageable
73
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