TRANSBIO Study: Clinical Evaluation of Immunobiogram, a Novel In Vitro Diagnostic Immunoassay to Guide Adjustment of Immunosuppressive Therapy in Kidney Transplantation
1Consorci Mar Parc de Salut, Barcelona, Spain, 2La Paz Hospital, Madrid, Spain, 3Wroclaw Medical University, Wroclaw, Poland, 4Massachusetts General Hospital, Boston, MA, 5Vall d’Hebron Hospital, Barcelona, Spain, 6Puerta de Hierro Mahadahonda Hospital, Madrid, Spain, 7University Hospital Essen, University Duisburg-Essen, Essen, Germany, 8Rigshospitalet, Copenhagen, Denmark, 912 de Octubre Hospital, Madrid, Spain, 10Biohope Scientific Solutions for Human Health SL, Madrid, Spain
Meeting: 2020 American Transplant Congress
Abstract number: 203
Keywords: Immunosuppression, Kidney transplantation, Monitoring, Multicenter studies
Session Information
Session Name: Biomarkers, Immune Assessment and Clinical Outcomes II
Session Type: Oral Abstract Session
Date: Saturday, May 30, 2020
Session Time: 3:15pm-4:45pm
Presentation Time: 4:03pm-4:15pm
Location: Virtual
*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 16, 2025.« Back to 2020 American Transplant Congress