BiologicTx® Announces Discovery 2 Life™ Platform (D2L™) and Three-Year Transplant Clinical Outcomes at The World Transplant Congress
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Uniting transplant therapeutics, research and digital health, BiologicTx® released three-year outcomes of patients treated with desensitization therapy resulting in a successful transplant:
BiologicTx® has partnered with 26 renal transplant programs in
Kidney Transplant Success Rates of Highly HLA-Sensitized
Of the patients receiving desensitizing therapy, 51 have received a deceased donor transplant while two received a living donor transplant, achieving an effective transplant rate of 49.53%. The median time to transplant was 3.8 months (range 6 days to 17 months) following start of IVIg desensitization. In these 53 patients, 51 (96%) were desensitized using high dose IVIg alone. Of the remaining patients, 83 are currently being desensitized and are awaiting transplant. One hundred and seven patients were discontinued from the desensitization program. Of those who did not complete desensitization, the major reasons were the following: inadequate response to treatment (43%), patient choice or noncompliance (16%), medical complications unrelated to desensitization treatment (12%), adverse events from IVIg use (8%), loss of intravenous access (7%), issues with insurance coverage (5%), and other (9%).
Antibody Mediated Rejection Rates and Post-Transplant Outcomes
With the 53 patients transplanted to date, the median follow-up is 13 months (range 1-36 months). The 12-month rejection rate in those with >1 year of follow-up (n=29) was 6%. This is a significantly lower percentage than the 12-month rejection rate of 10%, as reported in the 2012 OPTN/SRTR Data Report. Looking at all 53 patients transplanted, three patients, or 6%, have experienced antibody mediated rejection (AMR) episodes to date. Two of these episodes occurred in the first month post-transplant and the third occurred at six months post-transplant. In the remaining 50 patients, only one patient has experienced acute cellular rejection. In comparison to other desensitization program results, the AMR rate of 6% is much lower than the average AMR rate of 26% reported across major high dose IVIg desensitization programs.
Graft survival post-transplant remains excellent during the follow-up period in this cohort of patients. Two patients have experienced allograft failure representing a current survival of 96% in which one patient's transplant failed immediately during transplant (primary non-function) and the other had chronic rejection without evidence of previous acute rejection. A third patient died post-transplant due to infection (sepsis). To date, the graft survival rate in this deceased donor transplant population receiving desensitization is significantly higher than other reports in transplant medical journals of 78-91%.
Summary
In all, the early results of desensitization with primarily intravenous immune globulin alone has led to many transplants. These transplant patients have had low rates of antibody mediated rejection supporting that sensitized patients can receive transplantation after IVIg therapy. These encouraging results suggest that more centers should try to advance patients on the deceased donor waiting list with antibodies to transplant by using desensitization.
"Our commitment to the transplant community and intense focus on the combination of therapeutics, research and digital health is becoming more evident with the release of our desensitization outcomes and expansion of our digital health platform. It is just the beginning," said
About BiologicTx®
BiologicTx is a national specialty pharmacy that joins the administration of therapeutics, research, and digital health to advance the practice of solid organ transplant and chronic specialties. BiologicTx is comprised of four operating segments:
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SOURCE BiologicTx
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