- Three-year overall allograft survival was 84% in crossmatch positive patients treated with imlifidase.
- In patients with a cPRA of ≥99.9%, three-year allograft survival was 92%
-
Data published in an article accepted by the
American Journal of Transplantation
As reported in the article, which has been accepted for publication in the
"We are extremely pleased with these data that support the growing evidence base behind imlifidase", said
The rate of acute antibody-mediated rejection ("AMR") was 28% within the first month (n=11) following transplant, with four additional AMRs occurring between 2 and 6 months bringing the rate up to 38%. Few AMRs were reported beyond the first 6 months and only one patient recorded with an early AMR had an AMR during the follow-up period. All AMRs were treated with standard therapies and no graft losses were attributed to AMRs.
In the subset of patients deemed most highly sensitized and unlikely to be transplanted (n=13) with a calculated panel reactivity ("CPRA") of ≥99.9%, graft survival was 92% and kidney function improved over time with a mean eGFR of 60 mL/min/1.73m2 at three years. As expected, there was a high rate of AMR in this group (38%; n=5) within the first 14 days, with two further AMRs occurring between 5 and 6 months from transplantation. However, all these AMRs were treated with no graft losses attributed to the AMRs.
The frequency or severity of early AMR was not substantially different from what is expected and reported in highly sensitized candidates receiving incompatible kidneys. Overall, data from this study indicate that the incidence of AMR after imlifidsase is comparable to other desensitization protocols and manageable in this high-risk population and the long-term safety profile has indicated no increase in the rates of infection or malignancy.
Currently, around 10-30% of patients on transplant waiting lists are highly sensitized.[2] Highly sensitized patients are less likely to be offered a transplant, spend much longer on waiting lists, and have a higher chance of dying whilst waiting for a suitable donor.[3] There are approximately 80,000 kidney patients on transplant waiting lists across the
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Notes to Editors
About Idefirix® (imlifidase)
Imlifidase is an enzyme derived from the bacterium Streptococcus pyogenes, with the ability to specifically target and cleave (or break) all classes of immunoglobulin G (IgG) antibodies.[5]
IgG antibodies targeted specifically at the transplanted kidney are known as preformed Human Leukocyte Antigens (HLAs) or donor-specific antibodies (DSAs).[6] Highly sensitized patients have high levels of these preformed antibodies that can bind to the donor organ damaging the transplant.4 Once they are inactivated with Idefirix®, there is a window of opportunity for the transplant to take place. By the time the body starts renewing the depleted antibodies, the patient will be taking immunosuppressive therapy to continue to reduce the risk of organ rejection.
The efficacy and safety of Idefirix® as a pre-transplant treatment to reduce donor-specific IgG was studied in four phase 2 open-label, single-arm, six-month clinical trials.6,[7],[8],[9]
Idefirix® was granted conditional European Marketing Authorization from the European Medicine's Agency (EMA) in
About kidney failure
Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient's kidney function is less than 15%.4 ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide.9 A kidney transplant is the treatment of choice for suitable patients with ESRD because it offers improved survival and quality of life benefits compared to long-term dialysis. There are approximately 80,000 kidney patients on transplant waiting lists across the
Full product information can be accessed via the initial Summary of Product Characteristics found here
About
References
[1] Kjellman C, et al. Am J Transplantation 2021; ahead of publication
[2] ESOT Transplantation Learning Journey Highlights 15-17 November 2020-pg 25. Available at https://new.esot.org/wp-content/uploads/2021/01/TLJ20Report-.pd Last accessed:
[3] Keith D et al. Clin J Am Soc Nephrol 2016; 11: 684-693.
[4] Newsletter Transplant 2020. Available at: https://www.edqm.eu/en/news/newsletter-transplant-2020-now-available. Last accessed:
[5]
[6] Jordan SC, et al. N Engl J Med 2017; 377(5):442-453.
[7] Lorant T, et al. Am J Transplant 2018;18(11):2752-2762
[8] Winstedt L, et al. PLoS One 2015; 10(7): e0132011
[9]
[10]
https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-announces-long-term-follow-up-data-demonstrating-3-year-graft-survival-of-84--after-,c3383097
https://mb.cision.com/Main/1219/3383097/1443499.pdf
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