Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Preliminary Evidence of Good Safety Profile and Outcomes of Early Treatment With Tixagevimab/Cilgavimab Compared to Previously Employed Monoclonal Antibodies for COVID-19 in Immunocompromised Patients

Version 1 : Received: 17 January 2023 / Approved: 19 January 2023 / Online: 19 January 2023 (12:00:57 CET)

A peer-reviewed article of this Preprint also exists.

Lombardi, A.; Viero, G.; Villa, S.; Biscarini, S.; Palomba, E.; Azzarà, C.; Iannotti, N.; Mariani, B.; Genovese, C.; Tomasello, M.; Tonizzo, A.; Fava, M.; Valzano, A.G.; Morlacchi, L.C.; Donato, M.F.; Castellano, G.; Cassin, R.; Carrabba, M.; Muscatello, A.; Gori, A.; Bandera, A. Preliminary Evidence of Good Safety Profile and Outcomes of Early Treatment with Tixagevimab/Cilgavimab Compared to Previously Employed Monoclonal Antibodies for COVID-19 in Immunocompromised Patients. Biomedicines 2023, 11, 1540. Lombardi, A.; Viero, G.; Villa, S.; Biscarini, S.; Palomba, E.; Azzarà, C.; Iannotti, N.; Mariani, B.; Genovese, C.; Tomasello, M.; Tonizzo, A.; Fava, M.; Valzano, A.G.; Morlacchi, L.C.; Donato, M.F.; Castellano, G.; Cassin, R.; Carrabba, M.; Muscatello, A.; Gori, A.; Bandera, A. Preliminary Evidence of Good Safety Profile and Outcomes of Early Treatment with Tixagevimab/Cilgavimab Compared to Previously Employed Monoclonal Antibodies for COVID-19 in Immunocompromised Patients. Biomedicines 2023, 11, 1540.

Abstract

Objectives: Monoclonal antibodies (mAbs) have proven to be a valuable tool against COVID-19, mostly among subjects with risk factors for progression to severe illness. Tixagevimab/cilgavimab (TIX/CIL), a combination of two Fc-modified human monoclonal antibodies, has been recently approved to be employed as early treatment. Methods: Two groups of immunocompromised patients exposed to different early treatments (i.e., TIX/CIL vs. other mAbs [casirivimab/imdevimab, bamlanivimab/etesevimab, sotrovimab]) were compared in terms of clinical outcomes (hospitalization and mortality within 14 days from administration) and time to the negativity of nasal swabs. We used either Pearson’s chi-square or Fisher’s exact test for categorical variables, whereas the Wilcoxon rank–sum test was employed for continuous ones. Kaplan–Meier curves were produced to compare the time to nasopharyngeal swab negativity. Results: Early treatment with TIX/CIL was administered to 19 immunocompromised patients, while 89 patients received other mAbs. Most of them were solid organ transplant recipients or suffering from hematologic or solid malignancies. Overall, no significant difference was observed between the two groups in terms of clinical outcomes. In the TIX/CIL group, one patient (1/19, 5.3%), who was admitted to the emergency room within the first 14 days from treatment and was hospitalised due to COVID-19 progression, died. Regarding the time to nasal swab negativity, no significant difference (p=0.088) emerged. Conclusions: Early treatment of SARS-CoV-2 infection with TIX/CIL shows favourable outcomes in a small group of immunocompromised patients, reporting no significant difference when compared to similar patients treated with other mAbs.

Keywords

monoclonal antibodies; tixagevimab/cilgavimab; immunocompromised

Subject

Medicine and Pharmacology, Pharmacology and Toxicology

Comments (0)

We encourage comments and feedback from a broad range of readers. See criteria for comments and our Diversity statement.

Leave a public comment
Send a private comment to the author(s)
* All users must log in before leaving a comment
Views 0
Downloads 0
Comments 0
Metrics 0


×
Alerts
Notify me about updates to this article or when a peer-reviewed version is published.
We use cookies on our website to ensure you get the best experience.
Read more about our cookies here.