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0 0.5 1 1.5 2+ ICU admission 89% Improvement Relative Risk Oxygen therapy 85% Hospitalization 75% Bierle et al. Casirivimab/i.. for COVID-19 EARLY Favors casirivimab/im.. Favors control
Monoclonal Antibody Treatment of Breakthrough COVID-19 in Fully Vaccinated Individuals with High-Risk Comorbidities
Bierle et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab570 (date from earlier preprint)
Bierle et al., 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)
Oct 2021   Source   PDF  
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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.
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).
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.
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.
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.
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Abstract: Monoclonal Antibody Treatment of Breakthrough COVID-19 in Fully Vaccinated Individuals with High-Risk Comorbidities 1 Dennis M. Bierle, 1Ravindra Ganesh, 1Sidna Tulledge-Scheitel, 2Sara N. Hanson, 3Lori L. Arndt, Caroline G. Wilker, 1Raymund R. Razonable 4 us cr ip t 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 pt e 40-word summary d M 200 First Street SW, Rochester, MN 55905 an Division of Infectious Diseases Breakthrough COVID-19 may occur among vaccinated individuals with a high number of medical ce comorbidities, especially during the SARS-CoV-2 Delta surge. Anti-spike monoclonal antibody Ac 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: 1 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 t was significantly associated with a lower risk of hospitalization (Odds Ratio: 0.227; 95% confidence us cr ip 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. Ac ce pt e d M an Keywords: breakthrough covid-19, casirivimab-imdevimab, vaccination, covid-19, SARS-CoV-2, outcome, hospitalization 2 associated with the number of medical comorbidities. Anti-spike monoclonal antibody treatment Footnotes Funding: Mayo Clinic t us cr ip Conflict of Interest Statement: Dr. Razonable is principal investigator of research funded by Regeneron, Roche, Gilead (all funds an 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 M Mayo Clinic for studies on monoclonal antibodies for COVID-19. Ac ce pt e d All other no conflict to report. 3 Ethical approval: This study was approved by the Mayo Clinic Institutional Review Board.
Please send us corrections, updates, or comments. Vaccines and treatments are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment, vaccine, or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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