دورية أكاديمية

Long-Term Outcomes after Conversion to a Belatacept-Based Immunosuppression in Kidney Transplant Recipients.

التفاصيل البيبلوغرافية
العنوان: Long-Term Outcomes after Conversion to a Belatacept-Based Immunosuppression in Kidney Transplant Recipients.
المؤلفون: Divard G; INSERM U970 PARCC, Pa`ris Institute for Transplantation and Organ Regeneration, Université Paris Cité, Paris, France.; Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France., Aubert O; INSERM U970 PARCC, Pa`ris Institute for Transplantation and Organ Regeneration, Université Paris Cité, Paris, France.; Kidney Transplant Department, Necker Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France., Debiais-Deschamp C; INSERM U970 PARCC, Pa`ris Institute for Transplantation and Organ Regeneration, Université Paris Cité, Paris, France.; Kidney Transplant Department, Necker Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France., Raynaud M; INSERM U970 PARCC, Pa`ris Institute for Transplantation and Organ Regeneration, Université Paris Cité, Paris, France., Goutaudier V; INSERM U970 PARCC, Pa`ris Institute for Transplantation and Organ Regeneration, Université Paris Cité, Paris, France., Sablik M; INSERM U970 PARCC, Pa`ris Institute for Transplantation and Organ Regeneration, Université Paris Cité, Paris, France., Sayeg C; Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France., Legendre C; INSERM U970 PARCC, Pa`ris Institute for Transplantation and Organ Regeneration, Université Paris Cité, Paris, France.; Kidney Transplant Department, Necker Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France., Obert J; INSERM U970 PARCC, Pa`ris Institute for Transplantation and Organ Regeneration, Université Paris Cité, Paris, France., Anglicheau D; Kidney Transplant Department, Necker Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.; Necker-Enfants Malades Institute, INSERM U1151, Université de Paris Cité, Paris, France., Lefaucheur C; INSERM U970 PARCC, Pa`ris Institute for Transplantation and Organ Regeneration, Université Paris Cité, Paris, France.; Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France., Loupy A; INSERM U970 PARCC, Pa`ris Institute for Transplantation and Organ Regeneration, Université Paris Cité, Paris, France.; Kidney Transplant Department, Necker Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.
المصدر: Clinical journal of the American Society of Nephrology : CJASN [Clin J Am Soc Nephrol] 2024 May 01; Vol. 19 (5), pp. 628-637. Date of Electronic Publication: 2024 Feb 22.
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't; Multicenter Study
اللغة: English
بيانات الدورية: Publisher: Wolters Kluwer Health Country of Publication: United States NLM ID: 101271570 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1555-905X (Electronic) Linking ISSN: 15559041 NLM ISO Abbreviation: Clin J Am Soc Nephrol Subsets: MEDLINE
أسماء مطبوعة: Publication: 2023- : Hagerstown, MD : Wolters Kluwer Health
Original Publication: Washington, D.C. : American Society of Nephrology, c2005-
مواضيع طبية MeSH: Kidney Transplantation*/adverse effects , Abatacept*/therapeutic use , Abatacept*/adverse effects , Immunosuppressive Agents*/therapeutic use , Immunosuppressive Agents*/adverse effects , Graft Rejection*/immunology , Graft Rejection*/prevention & control, Humans ; Male ; Female ; Middle Aged ; Prospective Studies ; Adult ; Graft Survival/drug effects ; Time Factors ; Aged ; Treatment Outcome ; Calcineurin Inhibitors/adverse effects ; Calcineurin Inhibitors/therapeutic use
مستخلص: Background: Conversion to a belatacept-based immunosuppression is currently used as a calcineurin inhibitor (CNI) avoidance strategy when the CNI-based standard-of-care immunosuppression is not tolerated after kidney transplantation. However, there is a lack of evidence on the long-term benefit and safety after conversion to belatacept.
Methods: We prospectively enrolled 311 kidney transplant recipients from 2007 to 2020 from two referral centers, converted from CNI to belatacept after transplant according to a prespecified protocol. Patients were matched at the time of conversion to patients maintained with CNIs, using optimal matching. The primary end point was death-censored allograft survival at 7 years. The secondary end points were patient survival, eGFR, and safety outcomes, including serious viral infections, immune-related complications, antibody-mediated rejection, T-cell-mediated rejection, de novo anti-HLA donor-specific antibody, de novo diabetes, cardiovascular events, and oncologic complications.
Results: A total of 243 patients converted to belatacept (belatacept group) were matched to 243 patients maintained on CNIs (CNI control group). All recipient, transplant, functional, histologic, and immunologic parameters were well balanced between the two groups with a standardized mean difference below 0.05. At 7 years post-conversion to belatacept, allograft survival was 78% compared with 63% in the CNI control group ( P < 0.001 for log-rank test). The safety outcomes showed a similar rate of patient death (28% in the belatacept group versus 36% in the CNI control group), active antibody-mediated rejection (6% versus 7%), T-cell-mediated rejection (4% versus 4%), major adverse cardiovascular events, and cancer occurrence (9% versus 11%). A significantly higher rate of de novo proteinuria was observed in the belatacept group as compared with the CNI control group (37% versus 21%, P < 0.001).
Conclusions: This real-world evidence study shows that conversion to belatacept post-transplant was associated with lower risk of graft failure and acceptable safety outcomes compared with patients maintained on CNIs.
Clinical Trial Registry Name and Registration Number: Long-term Outcomes after Conversion to Belatacept, NCT04733131 .
(Copyright © 2024 by the American Society of Nephrology.)
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معلومات مُعتمدة: H2020 EUTRAIN (No. 754995) H2020 European Research Council; RHU KTDInnov (17-RHUS-0010) Agence Nationale de la Recherche; IM103435 Bristol-Myers Squibb
سلسلة جزيئية: ClinicalTrials.gov NCT04733131
المشرفين على المادة: 7D0YB67S97 (Abatacept)
0 (Immunosuppressive Agents)
0 (Calcineurin Inhibitors)
تواريخ الأحداث: Date Created: 20240124 Date Completed: 20240508 Latest Revision: 20240618
رمز التحديث: 20240619
مُعرف محوري في PubMed: PMC11108246
DOI: 10.2215/CJN.0000000000000411
PMID: 38265815
قاعدة البيانات: MEDLINE
الوصف
تدمد:1555-905X
DOI:10.2215/CJN.0000000000000411