Monoclonal Antibody Treatment of Breakthrough COVID-19 in Fully Vaccinated Individuals with High-Risk Comorbidities
et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab570 (date from earlier preprint)
, Monoclonal Antibody Treatment of Breakthrough COVID-19 in Fully Vaccinated Individuals with High-Risk.., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab570 (date from earlier preprint)
Retrospective 1,395 vaccinated COVID-19 cases, showing significantly lower hospitalization and oxygen supplementation with monoclonal antibody treatment, primarily casirivimab-imdevimab. Hospitalization was significantly associated with comorbidities.Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron [Liu, Sheward, Tatham, VanBlargan].
This study is excluded in meta
analysis:
patients were treated with different medications, results specific to each medication were not reported.
1.
Liu et al., bioRxiv, doi:10.1101/2021.12.14.472719,
Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2,
https://www.biorxiv.org/content/10.1101/2021.12.14.472719.
2.
Sheward et al., bioRxiv, doi:10.1101/2021.12.19.473354,
Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron),
https://www.biorxiv.org/content/10.1101/2021.12.19.473354.
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risk of ICU admission, 88.9% lower, RR 0.11, p = 0.16, treatment 0 of 527 (0.0%), control 5 of 868 (0.6%), NNT 174, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
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risk of oxygen therapy, 85.3% lower, RR 0.15, p < 0.001, treatment 5 of 527 (0.9%), control 56 of 868 (6.5%), NNT 18, odds ratio converted to relative risk.
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risk of hospitalization, 75.3% lower, RR 0.25, p < 0.001, treatment 14 of 527 (2.7%), control 93 of 868 (10.7%), NNT 12, odds ratio converted to relative risk.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Conflicts of interest:
research funding from the drug patent holder.
Bierle et al., 20 Oct 2021, retrospective, USA, peer-reviewed, 7 authors, average treatment delay 5.0 days.
Contact:
razonable.raymund@mayo.edu.
Abstract: Monoclonal Antibody Treatment of Breakthrough COVID-19 in Fully
Vaccinated Individuals with High-Risk Comorbidities
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Dennis M. Bierle, 1Ravindra Ganesh, 1Sidna Tulledge-Scheitel, 2Sara N. Hanson, 3Lori L. Arndt,
Caroline G. Wilker, 1Raymund R. Razonable
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Mayo Clinic, Rochester, MN, USA 2Mayo Clinic Health Systems, Mankato, MN, USA 3Mayo Clinic
Health Systems, Eau Claire, WI, USA and 4Mayo Clinic Health Systems – Franciscan Healthcare,
LaCrosse, WI, USA
Correspondence:
Raymund R Razonable, MD
Mayo Clinic
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40-word summary
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Razonable.raymund@mayo.edu
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200 First Street SW, Rochester, MN 55905
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Division of Infectious Diseases
Breakthrough COVID-19 may occur among vaccinated individuals with a high number of medical
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comorbidities, especially during the SARS-CoV-2 Delta surge. Anti-spike monoclonal antibody
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treatment was associated with significantly lower rates of hospitalization, particularly among highrisk persons.
© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of
America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.
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Abstract
Breakthrough COVID-19 may occur in fully vaccinated persons. In this cohort of 1395 persons (mean
age, 54.3 years; 60% female; median body mass index, 30.7) who developed breakthrough COVID19, there were 107 (7.7%) who required hospitalization by day 28. Hospitalization was significantly
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was significantly associated with a lower risk of hospitalization (Odds Ratio: 0.227; 95% confidence
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interval, 0.128 - 0.403; p<0.001). The number needed to treat (NNT) to prevent one hospitalization
was 225 among the lowest-risk patient group compared to NNT of 4 among those with highest
numbers of medical comorbidity.
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Keywords: breakthrough covid-19, casirivimab-imdevimab, vaccination, covid-19, SARS-CoV-2,
outcome, hospitalization
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associated with the number of medical comorbidities. Anti-spike monoclonal antibody treatment
Footnotes
Funding: Mayo Clinic
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Conflict of Interest Statement:
Dr. Razonable is principal investigator of research funded by Regeneron, Roche, Gilead (all funds
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provided to his institution), and is a member of Data Safety Monitoring Board of Novartis, on
projects not directly related to this submission. Dr. Razonable received research funds from the
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Mayo Clinic for studies on monoclonal antibodies for COVID-19.
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All other no conflict to report.
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Ethical approval: This study was approved by the Mayo Clinic Institutional Review Board.
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