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Tixagevimab/Cilgavimab as Pre-Exposure Prophylaxis against COVID-19 for Multiple Myeloma Patients: A Prospective Study in the Omicron Era
Background: tixagevimab/cilgavimab, distributed under the name “Evusheld”, was the first available pre-exposure prophylaxis for COVID-19 other than vaccination. It received an EUA from the FDA after sufficient trial data showed efficacy in preventing SARS-CoV-2 infections and subsequent severe disea...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10529256/ https://www.ncbi.nlm.nih.gov/pubmed/37754319 http://dx.doi.org/10.3390/diseases11030123 |
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author | Ntanasis-Stathopoulos, Ioannis Filippatos, Charalampos Gavriatopoulou, Maria Malandrakis, Panagiotis Eleutherakis-Papaiakovou, Evangelos Spiliopoulou, Vassiliki Syrigou, Rodanthi-Eleni Theodorakakou, Foteini Fotiou, Despina Migkou, Magdalini Roussou, Maria Kastritis, Efstathios Dimopoulos, Meletios Athanasios Terpos, Evangelos |
author_facet | Ntanasis-Stathopoulos, Ioannis Filippatos, Charalampos Gavriatopoulou, Maria Malandrakis, Panagiotis Eleutherakis-Papaiakovou, Evangelos Spiliopoulou, Vassiliki Syrigou, Rodanthi-Eleni Theodorakakou, Foteini Fotiou, Despina Migkou, Magdalini Roussou, Maria Kastritis, Efstathios Dimopoulos, Meletios Athanasios Terpos, Evangelos |
author_sort | Ntanasis-Stathopoulos, Ioannis |
collection | PubMed |
description | Background: tixagevimab/cilgavimab, distributed under the name “Evusheld”, was the first available pre-exposure prophylaxis for COVID-19 other than vaccination. It received an EUA from the FDA after sufficient trial data showed efficacy in preventing SARS-CoV-2 infections and subsequent severe disease. Its potential benefits for high-risk immunocompromised patients generated a lot of interest. Individuals with multiple myeloma fall into this category, as they are characterized by attenuated immune responses and, in some cases, vaccines have limited efficacy. Methods: this single-center, prospective study included consecutive patients with multiple myeloma. All individuals were considered high-risk for COVID-19 due to their underlying disease. Baseline demographic and clinical characteristics, as well as data regarding COVID-19 infection and antibodies, were collected. Patients were administered two intramuscular 150 mg doses of Evusheld and were monitored during the follow-up period. Results: one hundred and eleven multiple myeloma patients were included in this analysis, with a median age of 64 years (range 58–69) and fifty-three were females (47.7%). Fourteen patients (12.6%) had a prior history of COVID-19 and all patients were vaccinated with either three or four doses of mRNA-based vaccines. An increase was observed in the median neutralizing-antibody levels before and after tixagevimab/cilgavimab administration, from 92.6% to 97.3%. The high levels were sustainable, with a median neutralizing-antibody level of 95.4% at 3 months post Evusheld administration. Overall, nine patients (8.1%) were diagnosed with COVID-19 during the follow-up period, at a median of 31 days. There were no SARS-CoV-2- infection-related hospitalizations or deaths. The monoclonal antibody combination was well tolerated, with no infusion-related reactions or major adverse events, and pain at the injection site only was reported by 33 patients (30%). Conclusions: tixagevimab/cilgavimab (Evusheld) seemed beneficial for patients with multiple myeloma, who presented high neutralizing-antibody levels and a low incidence of COVID-19 during the initial Omicron wave. No new safety concerns emerged. However, novel combinations of monoclonal antibodies against the new circulating variants of SARS-CoV-2 are deemed necessary in view of the emergence of immune tolerance. |
format | Online Article Text |
id | pubmed-10529256 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-105292562023-09-28 Tixagevimab/Cilgavimab as Pre-Exposure Prophylaxis against COVID-19 for Multiple Myeloma Patients: A Prospective Study in the Omicron Era Ntanasis-Stathopoulos, Ioannis Filippatos, Charalampos Gavriatopoulou, Maria Malandrakis, Panagiotis Eleutherakis-Papaiakovou, Evangelos Spiliopoulou, Vassiliki Syrigou, Rodanthi-Eleni Theodorakakou, Foteini Fotiou, Despina Migkou, Magdalini Roussou, Maria Kastritis, Efstathios Dimopoulos, Meletios Athanasios Terpos, Evangelos Diseases Article Background: tixagevimab/cilgavimab, distributed under the name “Evusheld”, was the first available pre-exposure prophylaxis for COVID-19 other than vaccination. It received an EUA from the FDA after sufficient trial data showed efficacy in preventing SARS-CoV-2 infections and subsequent severe disease. Its potential benefits for high-risk immunocompromised patients generated a lot of interest. Individuals with multiple myeloma fall into this category, as they are characterized by attenuated immune responses and, in some cases, vaccines have limited efficacy. Methods: this single-center, prospective study included consecutive patients with multiple myeloma. All individuals were considered high-risk for COVID-19 due to their underlying disease. Baseline demographic and clinical characteristics, as well as data regarding COVID-19 infection and antibodies, were collected. Patients were administered two intramuscular 150 mg doses of Evusheld and were monitored during the follow-up period. Results: one hundred and eleven multiple myeloma patients were included in this analysis, with a median age of 64 years (range 58–69) and fifty-three were females (47.7%). Fourteen patients (12.6%) had a prior history of COVID-19 and all patients were vaccinated with either three or four doses of mRNA-based vaccines. An increase was observed in the median neutralizing-antibody levels before and after tixagevimab/cilgavimab administration, from 92.6% to 97.3%. The high levels were sustainable, with a median neutralizing-antibody level of 95.4% at 3 months post Evusheld administration. Overall, nine patients (8.1%) were diagnosed with COVID-19 during the follow-up period, at a median of 31 days. There were no SARS-CoV-2- infection-related hospitalizations or deaths. The monoclonal antibody combination was well tolerated, with no infusion-related reactions or major adverse events, and pain at the injection site only was reported by 33 patients (30%). Conclusions: tixagevimab/cilgavimab (Evusheld) seemed beneficial for patients with multiple myeloma, who presented high neutralizing-antibody levels and a low incidence of COVID-19 during the initial Omicron wave. No new safety concerns emerged. However, novel combinations of monoclonal antibodies against the new circulating variants of SARS-CoV-2 are deemed necessary in view of the emergence of immune tolerance. MDPI 2023-09-18 /pmc/articles/PMC10529256/ /pubmed/37754319 http://dx.doi.org/10.3390/diseases11030123 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Ntanasis-Stathopoulos, Ioannis Filippatos, Charalampos Gavriatopoulou, Maria Malandrakis, Panagiotis Eleutherakis-Papaiakovou, Evangelos Spiliopoulou, Vassiliki Syrigou, Rodanthi-Eleni Theodorakakou, Foteini Fotiou, Despina Migkou, Magdalini Roussou, Maria Kastritis, Efstathios Dimopoulos, Meletios Athanasios Terpos, Evangelos Tixagevimab/Cilgavimab as Pre-Exposure Prophylaxis against COVID-19 for Multiple Myeloma Patients: A Prospective Study in the Omicron Era |
title | Tixagevimab/Cilgavimab as Pre-Exposure Prophylaxis against COVID-19 for Multiple Myeloma Patients: A Prospective Study in the Omicron Era |
title_full | Tixagevimab/Cilgavimab as Pre-Exposure Prophylaxis against COVID-19 for Multiple Myeloma Patients: A Prospective Study in the Omicron Era |
title_fullStr | Tixagevimab/Cilgavimab as Pre-Exposure Prophylaxis against COVID-19 for Multiple Myeloma Patients: A Prospective Study in the Omicron Era |
title_full_unstemmed | Tixagevimab/Cilgavimab as Pre-Exposure Prophylaxis against COVID-19 for Multiple Myeloma Patients: A Prospective Study in the Omicron Era |
title_short | Tixagevimab/Cilgavimab as Pre-Exposure Prophylaxis against COVID-19 for Multiple Myeloma Patients: A Prospective Study in the Omicron Era |
title_sort | tixagevimab/cilgavimab as pre-exposure prophylaxis against covid-19 for multiple myeloma patients: a prospective study in the omicron era |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10529256/ https://www.ncbi.nlm.nih.gov/pubmed/37754319 http://dx.doi.org/10.3390/diseases11030123 |
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