TOTOWA, N.J., Sept. 22, 2016 /PRNewswire/ -- BiologicTx® released positive three-year clinical outcomes data of patients treated with desensitization therapy resulting in a successful transplant at the Desensitization And Transplant Antibodies (DATA) Course in Orlando, Florida on Thursday, September 22nd and Friday, September 23rd, 2016.
BiologicTx® has partnered with 34 transplant programs in the United States. Since April 2011, when BiologicTx began clinical operations, transplant centers collaborating with BiologicTx have started desensitization of 421 transplant candidates. In all 421 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
Three hundred sixty-one patients have completed desensitizing therapy as part of the collaboration. Of these 361 patients, 111 have reached transplant, achieving an effective transplant rate of 30.7%. The median time to transplant was 7.5 months (range 9 days to 41 months) following start of IVIg desensitization. Sixty-three percent of transplanted patients received 1-6 monthly doses of IVIg prior to transplant. Eighty-six 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 (32%), physician did not continue the IVIg therapy (16%), patient choice (9%), noncompliance (4%), loss of intravenous access (65%), medical issues (that included 3 deaths) unrelated to IVIg administration (10%), and issues with insurance coverage (4%). Adverse events related to IVIg administration occurred in 13% of the discontinued patients reporting hypertension, headache, thrombocytopenia, hemolytic anemia, low platelets and chest tightness. Currently, 60 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 (5%) of patients have experienced antibody mediated rejection (AMR) episodes to date. All AMR occurred in the first year post-transplant. Overall, only two patients have experienced acute cellular rejection. In comparison to other desensitization program results, the AMR rate of 5% 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 85 patients. Five patients have experienced allograft failure (6%). One, two, and three-year survival was 96%, 94%, and 90%, respectively. Two transplants failed immediately during transplant (primary non-function) while the other three cases experienced chronic alloantibody mediated rejection (CAMR). Death with a functioning graft occurred in three 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).
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 create more uniform desensitization guidelines for sensitized patients. Our encouraging results suggest that more centers should try to advance patients with pre-formed antibodies on the deceased donor waiting list to transplant by utilizing our proven desensitization approach. To review the whitepaper in its entirety, please click here.
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.
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