Session Name: Biomarkers, Immune Assessment and Clinical Outcomes II
Date: Saturday, May 30, 2020
Session Time: 3:15pm-4:45pm
Presentation Time: 4:03pm-4:15pm
*Purpose: Immunobiogram (IMBG) is a first-in-class blood-based pharmacodynamic immunoassay that provides the sensitivity/resistance profile of each patient’s lymphocytes to a panel of immunosuppressive drugs (IS). TRANSBIO is an international, multicenter clinical study to evaluate IMBG for robustness, association with clinical outcomes and intra-subject/inter-time consistency in Kidney Transplantation (KT).
*Methods: IMBG involves culture of PBMCs in a semi-solid 3D matrix, then submitted to immune stimulation. It reveals the capacity of an IS over a gradient to inhibit the activation of cells through dose-response curves, mathematically analyzed by a software using key curve parameters and finally translated into a resistance map. TRANSBIO study had 2 parts:
Part 1: IMBG of patients with Bad-Clinical-Evolution (BCE) (according to clinical outcomes and immune-biomarkers in previous 12-18 months) or Good-Clinical-Evolution (GCE) were compared. According to IS tested, each patient was classified as sensitive, resistant, partial-sensitive and normal responder. Two scores summarized the IMBG patient profile: for all IS tested (Global Score) or only for the IS taken (Prescribed Score, a 7-points scale from Sensitive++ to Resistant++).
Part 2: IMBG consistency was evaluated in stable patients by performing IMBG in triplicate at baseline and after one month.
*Results: Part 1 (n=103): A significant association between IMBG scores and bad prognoses was observed (p<0.05 and p=0.001 in Mann-Whitney U Test for the Global and Prescribed Scores respectively). In logistic regression analysis, the Prescribed IMBG Score was significantly associated with bad prognosis (OR 1.28, 95%CI 1.04-1.58, p=0.021). Therefore, each incremental step in this 7-point resistance scale implies a 28% increase in the probability of a bad prognosis for the patient.
Part 2 (n=61): IMBG showed intra-subject consistency (AOC variation less than 20% & CV 10%, ID50 variation less than 30% & CV 20%) and inter-time consistency (AOC variation less than 30%, ID50 slightly higher).
*Conclusions: IMBG measures the in vitro KT patient PBMCs sensitivity/resistance to IS. TRANSBIO study provides conclusive results about IMBG robustness, clinical prediction and consistency and may prove useful in guiding immunosuppression management.
To cite this abstract in AMA style:Pascual J, Jiménez C, Krajewska M, Kotton C, Seron D, Portolés J, Witzke O, Sorensen SS, Andrés A, Díez T, Ortega A, Portero I. TRANSBIO Study: Clinical Evaluation of Immunobiogram, a Novel In Vitro Diagnostic Immunoassay to Guide Adjustment of Immunosuppressive Therapy in Kidney Transplantation [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/transbio-study-clinical-evaluation-of-immunobiogram-a-novel-in-vitro-diagnostic-immunoassay-to-guide-adjustment-of-immunosuppressive-therapy-in-kidney-transplantation/. Accessed May 9, 2021.
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