Safety and efficacy of tixagevimab/cilgavimab for pre-exposure prophylaxis in kidney transplant recipients: a multicenter retrospective cohort study.

Kidney transplant Monoclonal antibodies Prophylaxis SARS-CoV-2

Journal

Journal of nephrology
ISSN: 1724-6059
Titre abrégé: J Nephrol
Pays: Italy
ID NLM: 9012268

Informations de publication

Date de publication:
23 May 2024
Historique:
received: 18 04 2023
accepted: 05 01 2024
medline: 23 5 2024
pubmed: 23 5 2024
entrez: 23 5 2024
Statut: aheadofprint

Résumé

Immunocompromised patients show an impaired vaccine response and remain at high risk of severe COVID-19, despite vaccination. Neutralizing monoclonal antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been developed for prophylaxis and treatment. The combination tixagevimab/cilgavimab (AZD7442) has been authorized for emergency use as pre-exposure prophylaxis for COVID-19, but data on safety and efficacy in kidney transplant recipients during the Omicron period are limited. We conducted a multicenter retrospective cohort study including 253 kidney transplant recipients, of whom 98 were treated with tixagevimab/cilgavimab 150 mg/150 mg and 155 who received only four doses of the BNT162b2 mRNA vaccine. Only 13.3% of patients developed SARS-CoV-2 infection after the administration of tixagevimab/cilgavimab; in comparison, 34.2% of patients had been infected after the fourth dose of vaccine (p = 0.00013). Most infected patients in the AZD7442 group remained asymptomatic (92.3% vs 54.7%), 7.7% had mild symptoms and none had severe disease, need for hospitalization or died, while in the control group, 9.4% of patients had moderate or severe disease (p = 0.04). Using Kaplan-Meier curves we demonstrated that the controls presented early infection compared to the AZD7442 group (p = 0.000014). No changes in eGFR or proteinuria, assessed before and after the administration, were observed. In conclusion, our study showed that tixagevimab/cilgavimab 150/150 mg is effective and safe in preventing infection and severe disease when administered to patients with weak or no response to COVID-19 vaccine.

Sections du résumé

BACKGROUND BACKGROUND
Immunocompromised patients show an impaired vaccine response and remain at high risk of severe COVID-19, despite vaccination. Neutralizing monoclonal antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been developed for prophylaxis and treatment. The combination tixagevimab/cilgavimab (AZD7442) has been authorized for emergency use as pre-exposure prophylaxis for COVID-19, but data on safety and efficacy in kidney transplant recipients during the Omicron period are limited.
METHODS METHODS
We conducted a multicenter retrospective cohort study including 253 kidney transplant recipients, of whom 98 were treated with tixagevimab/cilgavimab 150 mg/150 mg and 155 who received only four doses of the BNT162b2 mRNA vaccine.
RESULTS RESULTS
Only 13.3% of patients developed SARS-CoV-2 infection after the administration of tixagevimab/cilgavimab; in comparison, 34.2% of patients had been infected after the fourth dose of vaccine (p = 0.00013). Most infected patients in the AZD7442 group remained asymptomatic (92.3% vs 54.7%), 7.7% had mild symptoms and none had severe disease, need for hospitalization or died, while in the control group, 9.4% of patients had moderate or severe disease (p = 0.04). Using Kaplan-Meier curves we demonstrated that the controls presented early infection compared to the AZD7442 group (p = 0.000014). No changes in eGFR or proteinuria, assessed before and after the administration, were observed.
CONCLUSIONS CONCLUSIONS
In conclusion, our study showed that tixagevimab/cilgavimab 150/150 mg is effective and safe in preventing infection and severe disease when administered to patients with weak or no response to COVID-19 vaccine.

Identifiants

pubmed: 38780697
doi: 10.1007/s40620-024-01889-9
pii: 10.1007/s40620-024-01889-9
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s).

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Auteurs

Simona Simone (S)

Nephrology, Dialysis and Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.

Virginia Pronzo (V)

Nephrology, Dialysis and Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.

Francesco Pesce (F)

Nephrology, Dialysis and Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.

Davide Fiore Bavaro (DF)

Department of Biomedical Sciences and Human Oncology, Clinic of Infectious Diseases, University of Bari Aldo Moro, Bari, Italy.

Barbara Infante (B)

Renal Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.

Silvia Mercuri (S)

Renal Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.

Annalisa Schirinzi (A)

Clinic Pathology Unit, University Hospital of Bari, Bari, Italy.

Antonella Panaro (A)

Nephrology, Dialysis and Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.

Eleonora Conte (E)

Nephrology, Dialysis and Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.

Alessandra Belati (A)

Department of Biomedical Sciences and Human Oncology, Clinic of Infectious Diseases, University of Bari Aldo Moro, Bari, Italy.

Dario Troise (D)

Renal Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.

Paola Pontrelli (P)

Nephrology, Dialysis and Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.

Francesca Conserva (F)

Nephrology, Dialysis and Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.

Pasquale Gallo (P)

Nephrology, Dialysis and Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy.

Maddalena Panico (M)

Renal Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.

Marco Spilotros (M)

Urology, Andrology and Kidney Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari "Aldo Moro", 70124, Bari, Italy.

Giuseppe Lucarelli (G)

Urology, Andrology and Kidney Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari "Aldo Moro", 70124, Bari, Italy.

Annalisa Saracino (A)

Department of Biomedical Sciences and Human Oncology, Clinic of Infectious Diseases, University of Bari Aldo Moro, Bari, Italy.

Giovanni Stallone (G)

Renal Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.

Francesca Di Serio (F)

Clinic Pathology Unit, University Hospital of Bari, Bari, Italy.

Pasquale Ditonno (P)

Urology, Andrology and Kidney Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari "Aldo Moro", 70124, Bari, Italy.

Loreto Gesualdo (L)

Nephrology, Dialysis and Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy. loreto.gesualdo@uniba.it.

Classifications MeSH