Impact analysis of SARS-CoV-2 vaccination in patients treated with monoclonal antibodies: A monocentric experience.

COVID-19 Monoclonal antibody SARS-CoV-2 Vaccination Virological clearance

Journal

International immunopharmacology
ISSN: 1878-1705
Titre abrégé: Int Immunopharmacol
Pays: Netherlands
ID NLM: 100965259

Informations de publication

Date de publication:
11 Sep 2024
Historique:
received: 05 06 2024
revised: 03 08 2024
accepted: 03 09 2024
medline: 13 9 2024
pubmed: 13 9 2024
entrez: 12 9 2024
Statut: aheadofprint

Résumé

Since the discovery of SARS-CoV-2, no treatment has been able to completely eradicate the virus. The study aimed to evaluate the virological and clinical impact of the vaccination in SARS-CoV-2 infected patients treated with monoclonal antibodies (mAbs). This single-centre, observational, retrospective, real-life study was performed on SARS-CoV-2 symptomatic outpatients and inpatients treated with mAbs from March 2021 to November 2022 includes 726 patients. Each patient received available mAbs (bamlanivimab-etesevimab or casirivimab-indevimab or sotrovimab or tixagevimab-cilgavimab) according to the circulating virus strains. Age, comorbidities, vaccination status, death rates, duration of virological clearance, average length of stay, risk factors, and hospitalization or ICU admission were recorded. Of 726 patients with complete data analyzed (median age 64), 516 outpatients and 210 inpatients were included. Vaccination status was known for all participants: 74.4 % and 51.7 % were vaccinated against SARS-CoV-2 among inpatients and outpatients, respectively. A shorter duration of virological clearance was observed in the vaccinated group, with a median of 16 days (IQR 15-17), compared to 19 days (IQR 18-21) in the unvaccinated group [HR 1.21; p < 0.032]. Multivariate analysis of virological clearance also showed statistical significance with tixagevimab cilgavimab 300 mg/300 mg (HR 2.73, p value < 0.001). No significant difference was found in worsening [OR 1,29; p = 0.57] and mortality [OR 0.65; p = 0.81] rates between vaccinated and unvaccinated patients treated with mAbs. Key findings include a shorter duration of virological clearance in vaccinated outpatients but no significant differences in worsening or mortality rates between vaccinated and unvaccinated patients treated with mAbs. The study suggests a potential synergistic role of mAbs in accelerating virological clearance in vaccinated patients with mild to moderate COVID-19, with differing effects in hospitalized patients. Therefore, it is essential to implement health surveillance in high-risk patients with comorbidities in order to identify early any variants that might otherwise escape neutralizing antibodies.

Sections du résumé

BACKGROUND BACKGROUND
Since the discovery of SARS-CoV-2, no treatment has been able to completely eradicate the virus. The study aimed to evaluate the virological and clinical impact of the vaccination in SARS-CoV-2 infected patients treated with monoclonal antibodies (mAbs).
METHODS METHODS
This single-centre, observational, retrospective, real-life study was performed on SARS-CoV-2 symptomatic outpatients and inpatients treated with mAbs from March 2021 to November 2022 includes 726 patients. Each patient received available mAbs (bamlanivimab-etesevimab or casirivimab-indevimab or sotrovimab or tixagevimab-cilgavimab) according to the circulating virus strains. Age, comorbidities, vaccination status, death rates, duration of virological clearance, average length of stay, risk factors, and hospitalization or ICU admission were recorded.
RESULTS RESULTS
Of 726 patients with complete data analyzed (median age 64), 516 outpatients and 210 inpatients were included. Vaccination status was known for all participants: 74.4 % and 51.7 % were vaccinated against SARS-CoV-2 among inpatients and outpatients, respectively. A shorter duration of virological clearance was observed in the vaccinated group, with a median of 16 days (IQR 15-17), compared to 19 days (IQR 18-21) in the unvaccinated group [HR 1.21; p < 0.032]. Multivariate analysis of virological clearance also showed statistical significance with tixagevimab cilgavimab 300 mg/300 mg (HR 2.73, p value < 0.001). No significant difference was found in worsening [OR 1,29; p = 0.57] and mortality [OR 0.65; p = 0.81] rates between vaccinated and unvaccinated patients treated with mAbs.
CONCLUSIONS CONCLUSIONS
Key findings include a shorter duration of virological clearance in vaccinated outpatients but no significant differences in worsening or mortality rates between vaccinated and unvaccinated patients treated with mAbs. The study suggests a potential synergistic role of mAbs in accelerating virological clearance in vaccinated patients with mild to moderate COVID-19, with differing effects in hospitalized patients. Therefore, it is essential to implement health surveillance in high-risk patients with comorbidities in order to identify early any variants that might otherwise escape neutralizing antibodies.

Identifiants

pubmed: 39265354
pii: S1567-5769(24)01622-9
doi: 10.1016/j.intimp.2024.113101
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

113101

Informations de copyright

Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Nicola Perrotta (N)

Department of Physiology and Pharmacology "V. Erspamer" University of Rome, Sapienza, Italy; Pharmacy Unit, Policlinico Umberto I Hospital, Sapienza University of Rome, Italy. Electronic address: nicola.perrotta@uniroma1.it.

Luigi Angelo Fiorito (L)

Department of Physiology and Pharmacology "V. Erspamer" University of Rome, Sapienza, Italy; Pharmacy Unit, Policlinico Umberto I Hospital, Sapienza University of Rome, Italy. Electronic address: luigiangelo.fiorito@uniroma1.it.

Cristiana Leanza (C)

Department of Public Health and Infectious Diseases, Policlinico Umberto I Hospital, Sapienza University of Rome, Italy. Electronic address: cristiana.leanza@uniroma1.it.

Silvia Di Bari (S)

Department of Infectious and Tropical Diseases, Sant'Andrea Hospital University of Rome Sapienza, Italy. Electronic address: silvia1724dibari@gmail.com.

Gianfranco Casini (G)

Pharmacy Unit, Policlinico Umberto I Hospital, Sapienza University of Rome, Italy. Electronic address: g.casini@policlinicoumberto1.it.

Rossella Gentile (R)

Department of Physiology and Pharmacology "V. Erspamer" University of Rome, Sapienza, Italy; Pharmacy Unit, Policlinico Umberto I Hospital, Sapienza University of Rome, Italy. Electronic address: gentilerossella930@gmail.com.

Roberta Vescovo (R)

Pharmacy Unit, Policlinico Umberto I Hospital, Sapienza University of Rome, Italy. Electronic address: vescovoroberta96@gmail.com.

Alfonso Piciocchi (A)

Biostatistics Unit, GIMEMA Foundation, Rome, Italy. Electronic address: a.piciocchi@gimema.it.

Camilla Ajassa (C)

Department of Public Health and Infectious Diseases, Policlinico Umberto I Hospital, Sapienza University of Rome, Italy. Electronic address: camilla.ajassa@uniroma1.it.

Giancarlo Iaiani (G)

Department of Public Health and Infectious Diseases, Policlinico Umberto I Hospital, Sapienza University of Rome, Italy. Electronic address: giancarlo.iaiani@uniroma1.it.

Enrica Maria Proli (E)

Pharmacy Unit, Policlinico Umberto I Hospital, Sapienza University of Rome, Italy. Electronic address: e.proli@policlinicoumberto1.it.

Gianluca Russo (G)

Department of Public Health and Infectious Diseases, Policlinico Umberto I Hospital, Sapienza University of Rome, Italy. Electronic address: gianluca.russo@uniroma1.it.

Classifications MeSH