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1 Transplant Webinar Series: Ep. 9 Bio for Post-Transplant Immune Injury Future Webinars Link to register: All Content 215 Immucor, Inc. Handouts Program-Handouts.aspx All Content 215 Immucor, Inc. 1
2 Continuing Education ABHI, ASCLS/P.A.C.E., Florida and California Credits 1. Contact Hour or.15 continuing education credits (CECs) awarded Each attendee must register to receive CE credits at: Registration deadline is 12 October 218 Certificates will be sent via only to those who have registered by 26 October 218 All Content 215 Immucor, Inc. Presentation Recording Session will be recorded and posted to Immucor s LEARN site. Access information will be sent to each registrant when the recording becomes available CE credits will be issued to anyone who listens to the recording within one year of the original presentation date (today). To access Learn go to: learn.immucor.com All Content 215 Immucor, Inc. learn.immucor.com All Content 215 Immucor, Inc. 2
3 Questions? You are all muted Q&A following session - Type in questions All Content 215 Immucor, Inc. Course content is for information and illustration purposes only. Immucor makes no representation or warranties about the accuracy or reliability of the information presented and this information is not to be used for clinical or maintenance evaluations. The opinions contained in this presentation are those of the presenter and do not necessarily reflect those of Immucor. All Content 215 Immucor, Inc. Immune monitoring after kidney transplantation Maarten Naesens Maarten 52 nd Naesens, MD PhD ERA-EDTA meeting University of Leuven, Belgium London, May 215 3
4 Scoping Paper Work Programme : Personalised Medicine is one of the five research areas within Priority 1 The paradigm of personalized medicine PREDICT DIAGNOSE WAIT PREVENT TREAT 4
5 The paradigm of personalized medicine PREDICT DIAGNOSE PREVENT TREAT Personalized medicine builds on data and s Traditional medicine All patients same treatment Personalized medicine Predictive Data / Bio treatment X, not Y treatment Y, not X All patients Patients with confirmed disease Low risk for disease High risk for disease Low risk / good High risk / bad Non-invasive diagnostic Predictive Low disease probability High disease probability treatment X, not Y treatment Y, not X Non-invasive diagnostic Invasive diagnostic Start treatment X Start treatment Y No disease confirmation Disease confirmation Safety Pharmacodynamic / response Monitoring - Disease activity - Pharmacokinetics (exposure) Naesens & Anglicheau J Am Soc Nephrol 218 5
6 All patients Patients with confirmed disease Low risk for disease High risk for disease Low risk / good High risk / bad Non-invasive diagnostic Non-invasive diagnostic Predictive Low disease probability High disease probability treatment X, not Y treatment Y, not X Non-invasive diagnostic Invasive diagnostic Start treatment X Start treatment Y No disease confirmation Disease confirmation Safety Pharmacodynamic / response Monitoring - Disease activity - Pharmacokinetics (exposure) Naesens & Anglicheau J Am Soc Nephrol 218 All patients Patients with confirmed disease Low risk for disease High risk for disease Low risk / good High risk / bad Non-invasive diagnostic Predictive Low disease probability High disease probability treatment X, not Y treatment Y, not X Non-invasive diagnostic Invasive diagnostic Invasive diagnostic Start treatment X Start treatment Y No disease confirmation Disease confirmation Safety Pharmacodynamic / response Monitoring - Disease activity - Pharmacokinetics (exposure) Naesens & Anglicheau J Am Soc Nephrol 218 All patients Patients with confirmed disease Low risk for disease High risk for disease Low risk / good High risk / bad Non-invasive diagnostic Predictive Low disease probability High disease probability treatment X, not Y treatment Y, not X Non-invasive diagnostic Invasive diagnostic Start treatment X Start treatment Y No disease confirmation Disease confirmation Safety Pharmacodynamic / response Monitoring - Disease activity - Pharmacokinetics (exposure) Naesens & Anglicheau J Am Soc Nephrol 218 6
7 All patients Patients with confirmed disease Low risk for disease High risk for disease Low risk / good High risk / bad Non-invasive diagnostic Predictive Predictive Low disease probability High disease probability treatment X, not Y treatment Y, not X Non-invasive diagnostic Invasive diagnostic Start treatment X Start treatment Y No disease confirmation Disease confirmation Safety Pharmacodynamic / response Monitoring - Disease activity - Pharmacokinetics (exposure) Naesens & Anglicheau J Am Soc Nephrol 218 All patients Patients with confirmed disease Low risk for disease High risk for disease Low risk / good High risk / bad Non-invasive diagnostic Predictive Low disease probability High disease probability treatment X, not Y treatment Y, not X Non-invasive diagnostic Invasive diagnostic Start treatment X Start treatment Y No disease confirmation Disease confirmation Safety, pharmacodynamic, monitoring Safety Pharmacodynamic / response Monitoring - Disease activity - Pharmacokinetics (exposure) Naesens & Anglicheau J Am Soc Nephrol 218 All patients Patients with confirmed disease Low risk for disease High risk for disease Low risk / good High risk / bad Non-invasive diagnostic Non-invasive diagnostic Low disease probability High disease probability Predictive Predictive treatment X, not Y treatment Y, not X Non-invasive diagnostic Invasive diagnostic Invasive diagnostic Start treatment X Start treatment Y No disease confirmation Disease confirmation Safety Pharmacodynamic / response Safety, pharmacodynamic, monitoring Monitoring - Disease activity - Pharmacokinetics (exposure) 7
8 Non-invasive diagnostic PERSONALIZED MEDICINE Predictive Invasive diagnostic Safety, pharmacodynamic, monitoring KIDNEY TRANSPLANTATION Risk Diagnostic Predictive 8
9 Risk We have several widely used susceptibility/risk s in kidney transplantation Number of HLA mismatches Pretransplant PRA% Pretransplant DSA De novo DSA occurrence Success story of HLA genotyping and antibody profiling TRANSPLANTATION MEDICINE = FRONTRUNNER IN PERSONALIZED MEDICINE More personalization in allocation (AM program) leads to better outcome *AM = Eurotransplant Acceptable Mismatch program Heidt et al Kidney Int 218 9
10 More personalization in allocation (AM* program) leads to better outcome *AM = Eurotransplant Acceptable Mismatch program Heidt et al Kidney Int 218 More personalization in allocation: a role of high-resolution sequencing? Low resolution Acceptable MM at the antigen level High/allelic resolution Acceptable MM at the epitope level More personalization in allocation: a role of high-resolution sequencing? Low resolution Acceptable MM at the antigen level High/allelic resolution Acceptable MM at the epitope level 1
11 New risk s in the pipeline for kidney transplantation? Epitope mismatch load 1 Genetic assessment for ahus recurrence Urinary or serum supar for FSGS recurrence 2 FSGS recurrence panel 3 PLA2R and THSD7A antibodies for recurrence of membranous glomerulopathy 4,5 Donor-reactive T-cell response 6 Risk 1 Wiebe et al Transplantation 216; 2 Franco Palacios et al Transplantation 213; 3 Delville et al Sci Transl Med 214; 4 Sprangers et al Transplant Rev 213; 5 Tomas et al J Clin Invest 216; 6 Gandolfini et al Plos One 218 Risk Risk Diagnostic 11
12 We have several widely used diagnostic s in kidney transplantation Non-invasive: Serum creatinine/egfr Proteinuria Polyomavirus PCR Urinary mrna Urinary mirna Urinary protein Blood mrna Non-invasive diagnostic in the pipeline for kidney transplantation Specificty for acute rejection (%) Urinary mrna Sensitivity for acute rejection (%) mrna Perforin Granzyme B PI-9 CD13 FOXP3 CXCL1 NKG2D TIM3 Granulysin Multigene signature Naesens and Anglicheau, J Am Soc Nephrol 218 Non-invasive diagnostic in the pipeline for kidney transplantation Specificty for acute rejection (%) Urinary mrna Sensitivity for acute rejection (%) mrna Perforin Granzyme B PI-9 CD13 FOXP3 CXCL1 NKG2D TIM3 Granulysin Multigene signature Naesens and Anglicheau, J Am Soc Nephrol
13 Non-invasive diagnostic in the pipeline for kidney transplantation 1 Urinary proteins Specificty for acute rejection (%) Sensitivity for acute rejection (%) Proteins CXCL9 CXCL1 Fractalkine Naesens and Anglicheau, J Am Soc Nephrol 218 Non-invasive diagnostic in the pipeline for kidney transplantation 1 Blood mrna Specificty for acute rejection (%) Sensitivity for acute rejection (%) mrna Granzyme B Perforin FasL HLA-DRA Multigene signature Naesens and Anglicheau, J Am Soc Nephrol 218 Non-invasive diagnostic in the pipeline for kidney transplantation Specificty for acute rejection (%) Blood mrna Sensitivity for acute rejection (%) Trugraf ksort mrna Granzyme B Perforin FasL HLA-DRA Multigene signature Naesens and Anglicheau, J Am Soc Nephrol
14 The TruGraf assay needs further validation 2 peripheral blood mrna gene-set - early-access clinical programs started - large interventional trials ongoing - prospective, randomized, multi-center clinical trial ongoing Kurian et al Am J Transplant 214 CTOT-8 study yields a novel 57-gene marker for subclinical rejection 57-gene marker Diagnostic accuracy for subclinical TCMR Training set (N=53): NPV: 88% PPV: 61% Validation set (N=138): NPV: 78-8% Sens: 48% PPV: 47-51% Friedewald et al Am J Transplant 218 The ksort assay needs further validation 17 gene-set with published validation in case-control setting Roedder et al PLOS Med
15 We have several widely used diagnostic s in kidney transplantation Non-invasive: Serum creatinine/egfr Proteinuria Polyomavirus PCR Clinical value of novel? We have several widely used diagnostic s in kidney transplantation Non-invasive: Serum creatinine/egfr Proteinuria Polyomavirus PCR Clinical value of novel? Invasive: Histology of protocol biopsies Histology of for-cause (indication) biopsies Currently used diagnostic s don t capture subclinical injury Creatinine Proteinuria Diagnostic threshold Subclinical Acute dysfunction acute rejection Chronic dysfunction Time BX for cause I-BX I-BX I-BX Nankivell et al. NEJM 23 Lerut et al. Transplantation 27 Naesens et al. JASN 29 Ters et al. AJT
16 Currently used diagnostic s don t capture subclinical injury Creatinine Proteinuria Treatment Diagnostic threshold Subclinical Acute dysfunction acute rejection Acute pathology Chronic dysfunction BX for cause Time Nankivell et al. NEJM 23 Lerut et al. Transplantation 27 Naesens et al. JASN 29 Ters et al. AJT 213 Currently used diagnostic s don t capture subclinical injury Creatinine Proteinuria Treatment Diagnostic threshold Subclinical Acute dysfunction acute rejection Acute pathology BX for cause Protocol BX P-BX P-BX P-BX P-BX Chronic pathology Time Nankivell et al. NEJM 23 Lerut et al. Transplantation 27 Naesens et al. JASN 29 Ters et al. AJT 213 Immune injury in kidney transplant biopsies is defined according to the Banff classification Haas et al. Am J Transplant
17 Kidney transplant histology is problematic as a diagnostic Shinstock, Sapir-Pichhadze, Naesens et al Am J Transplant 218 Innovative diagnostic s for transplant injury are being developed Haas et al. Banff 217 paper - Am J Transplant 218 Invasive diagnostic in the pipeline for kidney transplantation From MMDx website: 17
18 Intrarenal NK cell mrna signatures accurately reflect ABMR disease activity ABMR vs NR 1 8 * NK cells total Activated NK cells Resting NK cells 1 Total NK cells 6 4 *** *** * * Sensitivity% 5 2 1/23/45/6 1/23/45/6 1/23/45/6 Microcirculation inflammation AUC =.98 P = 1.1E % - Specificity% Yazdani, Callemeyn et al Kidney Int In press Intrarenal NK cell mrna signatures accurately reflect ABMR disease activity and graft outcome 1 1 NK cells + Graft survival (%) 5 Low NK cells+ 196 High NK cells+ 86 Log-rank P = 1.7E-3 HR = 3.6 [ ] Low NK cells+ High NK cells Days after biopsy Sensitivity% 5 AUC =.74 P = 2.2E % - Specificity% Graft failure 1-year post-biopsy Yazdani, Callemeyn et al Kidney Int In press Risk Diagnostic 18
19 Risk Diagnostic egfr at 1 year is associated with graft outcome, and is a fair prognostic marker 1 MRDR egfr at 1 year and graft failure >7 ml/min ROC for graft failure 5 year after biopsy according to 1 year MDRD egfr 1 Graft survival (%) log-rank P< Time after biopsy (years) 6-7 ml/min 5-6 ml/min 4-5 ml/min 3-4 ml/min 2-3 ml/min <2 ml/min Sensitivity % AUC=.77 p< % - Specificity% Naesens et al (Unpublished) Proteinuria is a risk factor for graft failure but a poor prognostic marker B Percent survival No. at risk Biopsy time points (N=1335) log-rank P < Time after biopsy (years) Proteinuria <.3 g/24h.3-1. g/24h g/24h >3. g/24h C True Positive Fraction (%) Biopsy time points (N=1335) AUC=.66 (95% CI ) P < Naesens M et al J Am Soc Nephrol
20 The CADI score is a bad prognostic marker, despite the association with graft failure All biopsies: ROC for 5y graft loss 1 Graft survival (%) CADI score in indication biopsy log-rank P< Time after biopsy (years) N=1335 indication biopsies Naesens et al (Unpublished) CADI CADI 1 CADI 2-3 CADI 4-5 CADI 6-7 CADI 8-9 CADI >9 Sensitivity % Sensitivity % % - Specificity% AUC=.65 p<.1 Late biopsies: ROC for 5y graft loss (>1y) 1 2 AUC=.76 p< % - Specificity% We lack good prognostic s in kidney transplantation egfr Proteinuria Histology have on itself insufficient prognostic capacity We do not identify those the patients that need treatment Several prognostic are independent risk factors for graft failure Hazard ratio (95% CI) for kidney graft loss Proteinuria.3-1. vs. <.3 g/24h vs. <.3 g/24h >3. vs. <.3 g/24h egfr microcirc. inflammation IFTA 3-45 vs. >45 ml/min/m vs. >45 ml/min/m2 <15 vs. >45 ml/min/m2 g+ptc 2 vs. <2 Banff grade 1 vs. Banff grade 2-3 vs. model? Decide who to treat Transplant glomerulopathy GNF PVAN Banff grade 1 vs. Banff grade 2-3 vs. Present vs. absent Present vs. absent From Naesens et al J Am Soc Nephrol 215 2
21 Mathematical integration allows estimating individual Loupy et al under review Mathematical integration allows estimating individual Loupy et al under review in the pipeline for kidney transplantation Edmonton ABMR molecular score 1 Edmonton classifier for graft loss 2 GOCAR 13-geneset 3 1 Loupy et al JASN 213; 2 Einecke et al J Clin Invest 21; 3 O Connell Lancet
22 Molecular ABMR score predicts graft failure better than histology of ABMR INTERCOM STUDY (multicenter) ABMR Score - Histology - ABMR Score - Histology + ABMR Score + Histology + ABMR Score + Histology - ABMR score for graft loss: Sensitivity = 75% Specificity = 81% PPV = 48% NPV = 93% Halloran et al Am J Transplant 213 ROC AUC=.81 Molecular Risk score predicts graft outcome better than histology or proteinuria Low risk score Survival probability High risk score AUC=.83 Time after biopsy Einecke et al J Clin Invest 21 Risk score for graft loss: Early biopsies: Late biopsies: Sensitivity = 1% Sensitivity = 83% Specificity = 41% Specificity = 63% PPV = 5% PPV = 47% NPV = 1% NPV = 9% GoCAR score predicts CADI better than clinical and pathological parameters O Connell, Zhang et al Lancet
23 GoCAR score predicts graft outcome with reasonable accuracy O Connell, Zhang et al Lancet 216 GoCAR score for graft loss: PPV =? NPV =? ROC AUC=.84 Risk Diagnostic Risk Diagnostic Predictive 23
24 test = risk for graft failure Predictive test = success of therapy Patients with confirmed disease Low risk / good High risk / bad Naesens & Anglicheau J Am Soc Nephrol 218 test = risk for graft failure Predictive test = success of therapy Patients with confirmed disease Low risk / good High risk / bad Predictive Predictive treatment X, not Y treatment Y, not X Naesens & Anglicheau J Am Soc Nephrol 218 Start treatment X Start treatment Y test = risk for graft failure Predictive test = success of therapy Patients with confirmed disease Low risk / good High risk / bad Predictive Predictive treatment X, not Y treatment Y, not X Naesens & Anglicheau J Am Soc Nephrol 218 Start treatment X Start treatment Y 24
25 Non-invasive diagnostic Invasive diagnostic Safety, pharmacodynamic, monitoring Predictive 18/9/218 PERSONALIZED MEDICINE KIDNEY TRANSPLANTATION Thank you! Questions? You are all muted Q&A following session - Type in questions All Content 215 Immucor, Inc. 25
26 We like you! Like us on social media! All Content 215 Immucor, Inc. Questions? You are all muted Q&A following session - Type in questions All Content 215 Immucor, Inc. Continuing Education ABHI, ASCLS/P.A.C.E., Florida and California Credits 1. Contact Hour or.15 continuing education credits (CECs) awarded Each attendee must register to receive CE credits at: Registration deadline is 12 October 218 Certificates will be sent via only to those who have registered by 26 October 218 All Content 215 Immucor, Inc. 26
27 Future Webinars Link to register: All Content 215 Immucor, Inc. Thank you! All Content 215 Immucor, Inc. 27
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