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Editorial
. 2023 Jun 28:36:11244.
doi: 10.3389/ti.2023.11244. eCollection 2023.

Imlifidase for Kidney Transplantation of Highly Sensitized Patients With a Positive Crossmatch: The French Consensus Guidelines

Lionel Couzi  1   2 , Paolo Malvezzi  3 , Lucile Amrouche  4 , Dany Anglicheau  4 , Gilles Blancho  5 , Sophie Caillard  6 , Marine Freist  7 , Gwenda Line Guidicelli  8 , Nassim Kamar  9 , Carmen Lefaucheur  10 , Christophe Mariat  11 , Alice Koenig  12 , Johan Noble  3 , Olivier Thaunat  12 , Antoine Thierry  13 , Jean-Luc Taupin  10 , Dominique Bertrand  14
Affiliations
Editorial

Imlifidase for Kidney Transplantation of Highly Sensitized Patients With a Positive Crossmatch: The French Consensus Guidelines

Lionel Couzi et al. Transpl Int. .

Abstract

Imlifidase recently received early access authorization for highly sensitized adult kidney transplant candidates with a positive crossmatch against an ABO-compatible deceased donor. These French consensus guidelines have been generated by an expert working group, in order to homogenize patient selection, associated treatments and follow-up. This initiative is part of an international effort to analyze properly the benefits and tolerance of this new costly treatment in real-life. Eligible patients must meet the following screening criteria: cPRA ≥ 98%, ≤ 65-year of age, ≥ 3 years on the waiting list, and a low risk of biopsy-related complications. The final decision to use Imlifidase will be based on the two following criteria. First, the results of a virtual crossmatch on recent serum, which shall show a MFI for the immunodominant donor-specific antibodies (DSA) > 6,000 but the value of which does not exceed 5,000 after 1:10 dilution. Second, the post-Imlifidase complement-dependent cytotoxicity crossmatch must be negative. Patients treated with Imlifidase will receive an immunosuppressive regimen based on steroids, rATG, high dose IVIg, rituximab, tacrolimus and mycophenolic acid. Frequent post-transplant testing for DSA and systematic surveillance kidney biopsies are highly recommended to monitor post-transplant DSA rebound and subclinical rejection.

Keywords: desensitization; highly sensitized patients; imlifidase; kidney transplantation; positive crossmatch.

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Conflict of interest statement

LC has received lecture fees from Astellas, Chiesi, Novartis, Sandoz, Ostuka, GSK, Biotest, and participated on advisory boards for Biotest, Hansa, and Novartis. LA, DA, GG, CL, AK, J-LT, JN, and DB participated on advisory boards for Hansa. NK has received speakers fees from, and participated on advisory boards for Astellas, AstraZeneca, Biotest, CSL Behring, Chiesi, ExeViR, Hansa, Merck Sharp and Dohme, Glasgow Smith Kline, Novartis Pharma, Sanofi, Sandoz, and Takeda. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
The place of Imlifidase among the available strategies for highly sensitized patient transplantation. Adapted from Mamode et al. [13].
FIGURE 2
FIGURE 2
Access to a kidney transplantation according to cPRA in a French region including more 3,096 candidates listed between July 2009 and December 2015. Patients with a cPRA > 85% were included in the national priority program. These data were kindly given by D. Bertrand and collaborators who conducted this retrospective analysis in four transplant centers (Amiens, Caen, Lille, Rouen).
FIGURE 3
FIGURE 3
French criteria for selecting highly sensitized patients eligible to Imlifidase, permitted DSA and the timeline of crossmatches. cPRA, calculated panel reactive antibody; DSA, donor-specific antibody; MFI, mean fluorescence intensity.
FIGURE 4
FIGURE 4
The French consensus guidelines for therapies associated with Imlifidase in highly sensitized patients transplanted with a positive crossmatch. H, hour; rATG, rabbit antithymocyte globulin; IVIg, intravenous immunoglobulin.
FIGURE 5
FIGURE 5
The French consensus guidelines for monitoring and follow-up of patients transplanted with Imlifidase. AMR, antibody-mediated rejection.
See this image and copyright information in PMC

Comment in

References

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