BiologicTx® Announces Discovery 2 Life(TM) Platform (D2L(TM)) and Three-Year Transplant Clinical Outcomes at The World Transplant Congress
TOTOWA, N.J., July 28, 2014 /PRNewswire/ — BiologicTx(®) announced their Discovery 2 Life((TM)) (D2L((TM))), a leading digital health platform designed to guide and support hospitals, clinicians and patients throughout the organ transplant continuum. D2L supports aspects of the organ transplant process, including organization of data associated with enrolling a transplant candidate into a desensitization therapeutic program, donor data management (including identifying optimal donors from a paired donation pool), management of post-transplant therapies including immunosuppressive, antiviral, and rejection medications. From a single data source, all key information is organized and available to all physicians involved, histocompatibility laboratories, pharmacists and nurses.
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 the United States. Since April 2011, when BiologicTx began clinical operations, transplant centers collaborating with BiologicTx have started desensitization of 243 transplant candidates. In all 243 patients, the primary therapeutic modality was IVIg 2g/kg per month (split dose) infused through BiologicTx therapeutic services in an outpatient setting.
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%.
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.
Sal Rafanelli, RPh, CEO and Co-Founder of BiologicTx(®), stated “BiologicTx was founded on the principles of making a difference in the lives of the transplant patient. Our goal is to provide an outstanding service that produces extraordinary results. Our concepts in outpatient care combined with our digital health platform has proven just that. We are very pleased with our overall results and will strive to refine our corporate goals to maintain continued success for this patient population.”
“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 Darrin Carrico, President and Co-Founder at BiologicTx(®).
Todd Krasinsky, RN, Chief Development Officer and Co-Founder of BiologicTx(®) added, “We are extremely pleased with our outcome data and encourage other programs to participate. Our stringent clinical pathways and protocols were developed for proper patient selection which is what explains the success and why our results are favorable.”
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: BiologicTx Pharmacy and Therapeutic Services; BiologicTx Clinical Trials((TM)), which designs, sponsors, and aggregates clinical data, assisting in the publication of multicenter studies; BiologicTx Sequence((TM)), a digital health platform, including clinical intelligence and data integration, supporting clinicians and patients in achieving optimal outcomes; and BiologicTx Paired Donation((TM)), which offers an advanced software matching system, MatchGrid, and clinical decision intelligence to transplant centers. For more information, visit us at: www.BiologicTx.com.
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