Clinical Outcomes and Donor-specific Antibody Rebound 5 y After Kidney Transplant Enabled by Imlifidase Desensitization
Background. Imlifidase is an IgG-cleaving endopeptidase conditionally approved in Europe for desensitization of highly sensitized patients before kidney transplantation. We present 5-y outcomes and donor-specific antibody (DSA) levels for clinical trial participants from a single site who received i...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer
2025-02-01
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| Series: | Transplantation Direct |
| Online Access: | http://journals.lww.com/transplantationdirect/fulltext/10.1097/TXD.0000000000001752 |
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| author | Ian S. Jaffe, BS Anna Runström, MSc Vasishta S. Tatapudi, MD Elaina P. Weldon, MSN, ACNP-BC Cecilia L. Deterville, MS Rebecca A. Dieter, PharmD Robert A. Montgomery, MD, DPhil Bonnie E. Lonze, MD, PhD Massimo Mangiola, PhD |
| author_facet | Ian S. Jaffe, BS Anna Runström, MSc Vasishta S. Tatapudi, MD Elaina P. Weldon, MSN, ACNP-BC Cecilia L. Deterville, MS Rebecca A. Dieter, PharmD Robert A. Montgomery, MD, DPhil Bonnie E. Lonze, MD, PhD Massimo Mangiola, PhD |
| author_sort | Ian S. Jaffe, BS |
| collection | DOAJ |
| description | Background. Imlifidase is an IgG-cleaving endopeptidase conditionally approved in Europe for desensitization of highly sensitized patients before kidney transplantation. We present 5-y outcomes and donor-specific antibody (DSA) levels for clinical trial participants from a single site who received imlifidase for desensitization before incompatible transplantation (NCT02790437).
Methods. Imlifidase was administered up to 24 h before living or deceased donor kidney transplantation. DSAs were monitored before transplantation, at days 7 and 28, and at 5 y posttransplant.
Results. At 5 y, 7 of 8 participants were alive. One of these 7 had suboptimal graft function secondary to donor-derived disease but remained dialysis independent. Three participants had antibody-mediated rejection (AMR), which occurred in the first 30 d in all cases and was successfully treated. No new episodes of suspected or biopsy-proven AMR occurred after 30 d posttransplant. Seven participants had DSA rebound. DSAs commonly persisted 5 y posttransplant, although they were generally lower strength compared with pre-imlifidase. Dilution studies of sensitized serum enabled the identification of lower AMR risk phenotypes for persisting DSAs. Severe and/or opportunistic infections were not observed at greater than expected frequency.
Conclusions. Five-year outcomes of imlifidase-enabled incompatible transplants are overall favorable. DSA rebound is common, but antibody strength lessens in the long term, and longitudinally persisting DSAs did not lead to premature graft failure. |
| format | Article |
| id | doaj-art-eed2a22b335848ec92ede2d5263cc6bf |
| institution | Kabale University |
| issn | 2373-8731 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Wolters Kluwer |
| record_format | Article |
| series | Transplantation Direct |
| spelling | doaj-art-eed2a22b335848ec92ede2d5263cc6bf2025-01-24T09:21:00ZengWolters KluwerTransplantation Direct2373-87312025-02-01112e175210.1097/TXD.0000000000001752202502000-00003Clinical Outcomes and Donor-specific Antibody Rebound 5 y After Kidney Transplant Enabled by Imlifidase DesensitizationIan S. Jaffe, BS0Anna Runström, MSc1Vasishta S. Tatapudi, MD2Elaina P. Weldon, MSN, ACNP-BC3Cecilia L. Deterville, MS4Rebecca A. Dieter, PharmD5Robert A. Montgomery, MD, DPhil6Bonnie E. Lonze, MD, PhD7Massimo Mangiola, PhD81 Department of Surgery, New York University Grossman School of Medicine, New York, NY.3 Hansa Biopharma, Lund, Sweden.2 New York University Langone Transplant Institute, New York, NY.1 Department of Surgery, New York University Grossman School of Medicine, New York, NY.1 Department of Surgery, New York University Grossman School of Medicine, New York, NY.1 Department of Surgery, New York University Grossman School of Medicine, New York, NY.1 Department of Surgery, New York University Grossman School of Medicine, New York, NY.1 Department of Surgery, New York University Grossman School of Medicine, New York, NY.2 New York University Langone Transplant Institute, New York, NY.Background. Imlifidase is an IgG-cleaving endopeptidase conditionally approved in Europe for desensitization of highly sensitized patients before kidney transplantation. We present 5-y outcomes and donor-specific antibody (DSA) levels for clinical trial participants from a single site who received imlifidase for desensitization before incompatible transplantation (NCT02790437). Methods. Imlifidase was administered up to 24 h before living or deceased donor kidney transplantation. DSAs were monitored before transplantation, at days 7 and 28, and at 5 y posttransplant. Results. At 5 y, 7 of 8 participants were alive. One of these 7 had suboptimal graft function secondary to donor-derived disease but remained dialysis independent. Three participants had antibody-mediated rejection (AMR), which occurred in the first 30 d in all cases and was successfully treated. No new episodes of suspected or biopsy-proven AMR occurred after 30 d posttransplant. Seven participants had DSA rebound. DSAs commonly persisted 5 y posttransplant, although they were generally lower strength compared with pre-imlifidase. Dilution studies of sensitized serum enabled the identification of lower AMR risk phenotypes for persisting DSAs. Severe and/or opportunistic infections were not observed at greater than expected frequency. Conclusions. Five-year outcomes of imlifidase-enabled incompatible transplants are overall favorable. DSA rebound is common, but antibody strength lessens in the long term, and longitudinally persisting DSAs did not lead to premature graft failure.http://journals.lww.com/transplantationdirect/fulltext/10.1097/TXD.0000000000001752 |
| spellingShingle | Ian S. Jaffe, BS Anna Runström, MSc Vasishta S. Tatapudi, MD Elaina P. Weldon, MSN, ACNP-BC Cecilia L. Deterville, MS Rebecca A. Dieter, PharmD Robert A. Montgomery, MD, DPhil Bonnie E. Lonze, MD, PhD Massimo Mangiola, PhD Clinical Outcomes and Donor-specific Antibody Rebound 5 y After Kidney Transplant Enabled by Imlifidase Desensitization Transplantation Direct |
| title | Clinical Outcomes and Donor-specific Antibody Rebound 5 y After Kidney Transplant Enabled by Imlifidase Desensitization |
| title_full | Clinical Outcomes and Donor-specific Antibody Rebound 5 y After Kidney Transplant Enabled by Imlifidase Desensitization |
| title_fullStr | Clinical Outcomes and Donor-specific Antibody Rebound 5 y After Kidney Transplant Enabled by Imlifidase Desensitization |
| title_full_unstemmed | Clinical Outcomes and Donor-specific Antibody Rebound 5 y After Kidney Transplant Enabled by Imlifidase Desensitization |
| title_short | Clinical Outcomes and Donor-specific Antibody Rebound 5 y After Kidney Transplant Enabled by Imlifidase Desensitization |
| title_sort | clinical outcomes and donor specific antibody rebound 5 y after kidney transplant enabled by imlifidase desensitization |
| url | http://journals.lww.com/transplantationdirect/fulltext/10.1097/TXD.0000000000001752 |
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