Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients
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Safety, immunogenicity, pharmacokinetics, and efficacy of the IgG-degrading enzyme of Streptococcus pyogenes (IdeS [imlifidase]) were assessed in a single-center, open-label ascending-dose study in highly sensitized patients with chronic kidney disease. Eight patients with cytotoxic PRAs (median cytotoxic PRAs of 64%) at enrollment received 1 or 2 intravenous infusions of IdeS on consecutive days (0.12 mg/kg body weight ×2 [n = 3]; 0.25 mg/kg ×1 [n = 3], or 0.25 mg/kg ×2 [n = 2]). IgG degradation was observed in all subjects after IdeS treatment, with <1% plasma IgG remaining within 48 hours and remaining low up to 7 days. Mean fluorescence intensity values of HLA class I and II reactivity were substantially reduced in all patients, and C1q binding to anti-HLA was abolished. IdeS also cleaved the IgG-type B cell receptor on CD19 + memory B cells. Anti-IdeS antibodies developed 1 week after treatment, peaking at 2 weeks. A few hours after the second IdeS infusion, 1 patient received a deceased donor kidney offer. At enrollment, the patient had a positive serum crossmatch (HLA-B7), detected by complement-dependent cytotoxicity, flow cytometry, and multiplex bead assays. After IdeS infusion (0.12 mg/kg ×2) and when the HLA-incompatible donor (HLA-B7 + ) kidney was offered, the HLA antibody profile was negative. The kidney was transplanted successfully.
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Imlifidase is a IgG-degrading cysteine protease derived from Streptococcus pyogenes (IdeS), which specifically cleaves opsonizing IgG at the lower hinge region of the heavy chains, resulting in a F(ab')2 and a non-functioning dimeric Fc fragment.
“Imlifidase (Idefirix, Hansa Biopharma) is a IgG-degrading cysteine protease derived from Streptococcus pyogenes (IdeS), which specifically cleaves opsonizing IgG at the lower hinge region of the heavy chains, resulting in a F(ab’)2 and a non-functioning dimeric Fc fragment (82).”
From Immunomodulation in Administration of RAAV: Preclinical and Clinical Adjuvant Pharmacotherapies (2021) · cites this paper as [82]
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- Authors
- Lorant, T., Bengtsson, M., Eich, T., Eriksson, B.-M., Winstedt, L., Järnum, S., Stenberg, Y., Robertson, A.-K., Mosén, K., Björck, L., Bäckman, L., Larsson, E., Wood, K., Tufveson, G., & Kjellman, C.
- Affiliations
- Uppsala University (SE)
- Hansa Biopharma (Sweden) (SE)
- Lund University (SE)
- University of Oxford (GB)
- Corresponding author
- Kjellman, Christian
- ORCID
- Venue
- American Journal of Transplantation
- Publisher
- Elsevier BV
- Published
- 2018-11
- Volume
- 18
- Issue
- 11
- Pages
- 2752-2762
- ISSN
- 1600-6135 (ISSN-L)
- PMC
- PMC6221156
- OpenAlex
- W2789946756
- Cited by
- 108
- References
- 23
- Citations by year
- 2026: 11 · 2025: 11 · 2024: 18 · 2023: 14 · 2022: 18 · 2021: 12 · 2020: 12 · 2019: 11 · 2018: 1
- FWCI
- 7.69
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- American Journal of Transplantation (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Uppsala University Publications (Uppsala University) (submittedVersion, other-oa)
- Lund University Publications (Lund University) (submittedVersion)
- Topics
- Health Sciences › Medicine › Transplantation › Renal Transplantation Outcomes and Treatments
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Life Sciences › Immunology and Microbiology › Immunology › Complement system in diseases
- Keywords
- ide, imlifidase, HLA antibodies, chronic kidney disease, HLA sensitization, IgG degradation, complement-dependent cytotoxicity, HLA crossmatch, kidney transplantation, immunogenicity, pharmacokinetics
- MeSH terms
- Adult, Aged, Bacterial Proteins, Desensitization, Immunologic, Female, Follow-Up Studies, Graft Rejection, Graft Survival, Histocompatibility, HLA Antigens, Humans, Immunoglobulin G, Infusions, Intravenous, Isoantibodies, Male, Middle Aged, Prognosis, Risk Factors, Streptococcus pyogenes, Complement C1q, Kidney Transplantation, Renal Insufficiency, Chronic
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