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All Studies   Meta Analysis    Recent:   

Real-World Effectiveness and Tolerability of Monoclonal Antibody Therapy for Ambulatory Patients with Early COVID-19

Webb et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab331
Jun 2021  
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Mortality 80% Improvement Relative Risk Hospitalization 53% Hospitalization/ER 27% primary Bamlanivimab/e..  Webb et al.  EARLY TREATMENT Is early treatment with bamlanivimab/etesevimab beneficial for COVID-19? Retrospective 6,015 patients in the USA Lower hospitalization (p<0.0001) and fewer hosp./ER visits (p<0.0001) c19early.org Webb et al., Open Forum Infectious Dis.., Jun 2021 Favorsbamlanivimab/e.. Favorscontrol 0 0.5 1 1.5 2+
21st treatment shown to reduce risk in May 2021
 
*, now with p = 0.00036 from 21 studies, recognized in 7 countries. Efficacy is variant dependent.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 81 treatments. c19early.org
Retrospective 479 patients treated with bamlanivimab showing lower mortality, hospital admission, and emergency department visits with treatment. Authors incorrectly state that "no other COVID-19 therapies for ambulatory patients have proven effective".
Efficacy is highly variant dependent. In Vitro research suggests a lack of efficacy for omicron1-5.
Study covers casirivimab/imdevimab and bamlanivimab/etesevimab.
risk of death, 79.7% lower, RR 0.20, p = 0.09, treatment 1 of 479 (0.2%), control 57 of 5,536 (1.0%), NNT 122.
risk of hospitalization, 52.7% lower, RR 0.47, p < 0.001, treatment 22 of 479 (4.6%), control 538 of 5,536 (9.7%), NNT 20.
risk of hospitalization/ER, 26.8% lower, RR 0.73, p < 0.001, treatment 65 of 479 (13.6%), control 1,018 of 5,536 (18.4%), NNT 21, odds ratio converted to relative risk, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Webb et al., 23 Jun 2021, retrospective, USA, peer-reviewed, 14 authors.
This PaperBamlaniv../e..All
Real-world Effectiveness and Tolerability of Monoclonal Antibody Therapy for Ambulatory Patients With Early COVID-19
MD Brandon J Webb, Whitney Buckel, Todd Vento, Allison M Butler, Nancy Grisel, Samuel M Brown, Ithan D Peltan, Emily S Spivak, Mark Shah, Theadora Sakata, Anthony Wallin, Eddie Stenehjem, Greg Poulsen, Joseph Bledsoe
Open Forum Infectious Diseases, doi:10.1093/ofid/ofab331
Background. Neutralizing monoclonal antibodies (MAbs) are a promising therapy for early coronavirus disease 2019 , but their effectiveness has not been confirmed in a real-world setting. Methods. In this quasi-experimental pre-/postimplementation study, we estimated the effectiveness of MAb treatment within 7 days of symptom onset in high-risk ambulatory adults with COVID-19. The primary outcome was a composite of emergency department visits or hospitalizations within 14 days of positive test. Secondary outcomes included adverse events and 14-day mortality. The average treatment effect in the treated for MAb therapy was estimated using inverse probability of treatment weighting and the impact of MAb implementation using propensity-weighted interrupted time series analysis. Results. Pre-implementation (July-November 2020), 7404 qualifying patients were identified. Postimplementation (December 2020-January 2021), 594 patients received MAb treatment and 5536 did not. The primary outcome occurred in 75 (12.6%) MAb recipients, 1018 (18.4%) contemporaneous controls, and 1525 (20.6%) historical controls. MAb treatment was associated with decreased likelihood of emergency care or hospitalization (odds ratio, 0.69; 95% CI, 0.60-0.79). After implementation, the weighted probability that a given patient would require an emergency department visit or hospitalization decreased significantly (0.7% per day; 95% CI, 0.03%-0.10%). Mortality was 0.2% (n = 1) in the MAb group compared with 1.0% (n = 71) and 1.0% (n = 57) in pre-and postimplementation controls, respectively. Adverse events occurred in 7 (1.2%); 2 (0.3%) were considered serious. Conclusions. MAb treatment of high-risk ambulatory patients with early COVID-19 was well tolerated and likely effective at preventing the need for subsequent emergency department or hospital care.
Supplementary Data Supplementary materials are available at Open Forum Infectious Diseases online. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author.
References
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Cevik, Tate, Lloyd, SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review and meta-analysis, Lancet Microbe
Charlson, Pompei, Ales, Mackenzie, A new method of classifying prognostic comorbidity in longitudinal studies: development and validation, J Chronic Dis
Chatellier, Zapletal, Lemaitre, The number needed to treat: a clinically useful nomogram in its proper context, BMJ
Chen, Nirula, Heller, BLAZE-1 Investigators. SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19, N Engl J Med
Elixhauser, Steiner, Harris, Coffey, Comorbidity measures for use with administrative data, Med Care
Gottlieb, Nirula, Chen, Effect of bamlanivimab as monotherapy or in combination with etesevimab on viral load in patients with mild to moderate COVID-19: a randomized clinical trial, JAMA
Libster, Marc, Wappner, Fundación INFANT-COVID-19 Group. Early high-titer plasma therapy to prevent severe Covid-19 in older adults, N Engl J Med
Rubin, Estimating causal effects from large data sets using propensity scores, Ann Intern Med
Wagner, Soumerai, Zhang, Ross-Degnan, Segmented regression analysis of interrupted time series studies in medication use research, J Clin Pharm Ther
Webb, Levin, Grisel, Simple scoring tool to estimate risk of hospitalization and mortality in ambulatory and emergency department patients with COVID-19, MedRxiv, doi:10.1101/2021.02.22.21252171
Weinreich, Sivapalasingam, Norton, Trial Investigators. REGN-COV2, a neutralizing antibody cocktail, in outpatients with Covid-19, N Engl J Med
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