BiologicTx® Announces Positive Four-Year Transplant Success Rates

Results Demonstrate Continued Deceased Donor Desensitization Success

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Jul 01, 2015, 03:39 ET

TOTOWA, N.J., July 1, 2015 /PRNewswire/ -- BiologicTx^® released four-year outcomes of patients treated with desensitization therapy resulting in a successful transplant:

BiologicTx^® has partnered with 31 transplant programs in the United States. Since April 2011, when BiologicTx began clinical operations, transplant centers collaborating with BiologicTx have started desensitization of 367 transplant candidates. In all 367 patients, the primary therapeutic modality was IVIg 2g/kg per month (split dose) infused through BiologicTx therapeutic services in an outpatient setting.

Transplant Success Rates of Highly HLA-Sensitized

Two hundred sixty-nine patients have completed desensitizing therapy as part of the collaboration. Of these 269 patients, 85 have reached transplant, achieving an effective transplant rate of 31.5%. The median time to transplant was 3.9 months (range 4 days to 23 months) following start of IVIg desensitization. Seventy-two percent of transplanted patients received 1-6 monthly doses of IVIg prior to transplant. Eighty-five percent of all transplanted recipients were desensitized using high dose IVIg alone. Of those who did not complete desensitization, the major reasons were the following: inadequate response to treatment (37%), patient choice or noncompliance (12%), medical complications (that included 3 deaths) unrelated to desensitization treatment (17%), loss of intravenous access (5%), and issues with insurance coverage (3%). Adverse events related to IVIg administration occurred in 10% of the discontinued patients reporting hypertension, headache, thrombocytopenia, hemolytic anemia, low platelets and chest tightness. Currently, 105 patients are still undergoing desensitization therapy and are awaiting transplant.

Antibody Mediated Rejection Rates and Post-Transplant Outcomes

In all of the transplanted patients, four (4.7%) have experienced antibody mediated rejection (AMR) episodes to date. All AMR occurred in the first year post-transplant. Overall, only one patient has experienced acute cellular rejection (0.1%). In comparison to other desensitization program results, the AMR rate of 4.7% is much lower than the average AMR rate (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. Three patients have experienced allograft failure (current survival 96.5%). One transplant failed immediately during transplant (primary non-function) while the other two had chronic rejection. Death with a functioning graft occurred in two patients due to infection (Sepsis). To date, the graft survival rate in this deceased donor transplant population receiving desensitization is better than other reports (78-91% survival).

Summary

Based on this large cohort we are now able to show that desensitization with IVIg can allow patients to reach transplant with a low risk of AMR and excellent allograft function post-transplant. By using one protocol in a large number of patients we feel that we have strong evidence to build desensitization guidelines. Our encouraging results suggest that more centers should try to advance patients on the deceased donor waiting list with antibodies to transplant by using our proven desensitization approach. To review the whitepaper in its entirety, please click here.

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: BiologicTx Pharmacy and Therapeutic Services; BiologicTx Clinical Trials^™, which designs, sponsors, and aggregates clinical data, assisting in the publication of multicenter studies; BiologicTx Sequence^™, a digital health platform, including clinical intelligence and data integration, supporting clinicians and patients in achieving optimal outcomes; and BiologicTx Paired Donation^™, which offers an advanced software matching system, MatchGrid, and clinical decision intelligence to transplant centers. For more information, visit us at: www.BiologicTx.com.