IMMUNOBIOGRAM® (IMBG) CLINICAL STUDIES IN KIDNEY TRANSPLANTATION

The most important challenge in Kidney Transplantation is to achieve the long-term survival of the transplanted organ, as 50% of patients will suffered a graft loss in the next 10 years following transplantation.  To avoid the risk of graft rejection, patients require long term treatment with immunosuppressive drugs (IMS) but this treatment can also cause severe adverse events. Currently IMS regimens are established empirically, based only on guidelines, monitoring of IMS plasmatic levels and side effects. The current strategy may lead to either under-immunosuppression (resulting in rejections) or over-immunosuppression (resulting in side effects).

50% of patients in Kidney Transplantation

will suffer a graft loss in the next 10 years following transplantation

Immunobiogram ® (IMBG) is a first-in-class pharmacodynamic immunoassay that provides the sensitivity/resistance profile of each patient to a panel of IMS tested and has the potential to help clinicians to individualize IMS treatment adjustment.

IMBG has been tested for Kidney Transplantation (KT) in two clinical studies that belong to the TRANSBIO Project (Cellular BIOtechnology for prognosis and monitoring in renal TRANSplantation), supported by the European Union Horizon 2020 Programme for Research and Innovation as a SME instrument Phase 2 under grant agreement Nº 733248:

BH-PILOT 2015

BH-Pilot 2015  was a proof of concept clinical study performed in 2015-2016 in two important University Hospitals from Madrid. The study included 70 renal-transplanted patients at least 1 year after the transplant (immunosuppression maintenance period), and classified as high- immunological-risk, low-risk and standard based on their clinical and immunological characteristics.

TRANSBIO STUDY

TRANSBIO STUDY is an international, multicenter clinical study performed to confirm BH-Pilot 2015 results and to achieve the technical validation of the IMBG.  It was performed in nine major University Hospitals in Europe and USA with more than 200 patients recruited.

The study objectives were to evaluate IMBG robustness, the association with clinical prognoses and its consistency in Kidney Transplantation (KT).

The studies show these results:

  • IMBG provides an individualized patient response pattern to immunosuppressive medication. Sensitivity ranges can be determined in each patient for each of the drugs tested.

  • Significantly associated high-resistance patterns to IMS in IMBG have been observed in patients with a high- immunological- risk profile and who present worse clinical evolution.

  • Patients with a low- immunological-risk profile showed better sensitivity scores to IMS in IMBG compared with standard patients and high- immunological-risk patients.

  • Additionally, two scores allowed to summarize IMBG patient profile:

      • The Global IMBG Score (to all IMS tested) or the Prescribed IMBG Score (only for the IMS taken) in a 7 levels scale, from more sensitive (Se++) to more resistant (Re++).
  • Significant differences were found in both IMBG Scores between patients with Bad Clinical Evolution (with renal function deterioration and immunological markers/signs of graft rejection in previous 12-18 months) and Good Clinical Evolution. The Prescribed IMBG Score showed that each step forward in the scale towards resistance increase the probability of a bad prognosis for the patient in a significant way.

  • IMBG showed intra-subject and inter-time

PROGNOSIS

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