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0 0.5 1 1.5 2+ Mortality 44% Improvement Relative Risk Hospitalization 65% Rubin et al. Bamlanivimab/e.. for COVID-19 EARLY Is early treatment with bamlanivimab/etesevimab beneficial for COVID-19? Retrospective 1,257 patients in the USA (December 2020 - February 2021) Lower hospitalization with bamlanivimab/etesevimab (p=0.041) Rubin et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab546 Favors bamlanivimab/e.. Favors control
Bamlanivimab efficacy in older and high BMI outpatients with Covid-19 selected for treatment in a lottery-based allocation process
Rubin et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab546
Rubin et al., Bamlanivimab efficacy in older and high BMI outpatients with Covid-19 selected for treatment in a.., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab546
Nov 2021   Source   PDF  
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Retrospective database analysis of 1257 PCR+ outpatients with age ≥65, BMI≥35, 191 receiving bamlanivimab via lottery. Authors note that the alpha variant was most common during the study period, and that efficacy against other variants can be much lower. Authors note confounding due to prioritization in the lottery and differential reporting in the database.
Efficacy is highly variant dependent. In Vitro research suggests a lack of efficacy for omicron [Liu, Sheward, VanBlargan]. This study is excluded in the after exclusion results of meta analysis: significant unadjusted confounding possible.
risk of death, 44.2% lower, RR 0.56, p = 1.00, treatment 1 of 191 (0.5%), control 10 of 1,066 (0.9%), NNT 241.
risk of hospitalization, 65.3% lower, RR 0.35, p = 0.04, treatment 16 of 191 (8.4%), control 121 of 1,065 (11.4%), odds ratio converted to relative risk, IPTW weighted logistic regression.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Conflicts of interest: research funding from the drug patent holder, consulting for the pharmaceutical industry.
Rubin et al., 3 Nov 2021, retrospective, USA, peer-reviewed, 7 authors, study period 9 December, 2020 - 25 February, 2021, average treatment delay 6.0 days.
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Bamlanivimab Efficacy in Older and High-BMI Outpatients With COVID-19 Selected for Treatment in a Lottery-Based Allocation Process
MD, JD, MSHP Emily B Rubin, Jonathan A Boiarsky, Lauren A Canha, Anita Giobbie-Hurder, Mofei Liu, Matthew J Townsend, Michael Dougan
Open Forum Infectious Diseases, doi:10.1093/ofid/ofab546
Background. Given the challenges associated with timely delivery of monoclonal antibody (mAb) therapy to outpatients with coronavirus disease 2019 (COVID-19) who are most likely to benefit, it is critical to understand the effectiveness of such therapy outside the context of clinical trials. Methods. This was a case-control study of 1257 adult outpatients with COVID-19, ≥65 years of age or with body mass index (BMI) ≥35, who were entered into a lottery for mAb therapy. Results. Patients who were called to be offered mAb therapy had a statistically significant 44% reduction in the odds of hospitalization within 30 days of a positive severe acute respiratory syndrome coronavirus 2 test compared with those who were not called (odds ratio [OR], 0.56; 95% CI, 0.36-0.89; P = .01). Patients who actually received bamlanivimab had a statistically significant 68% reduction in the odds of hospitalization compared with those who did not receive bamlanivimab (OR, 0.32; 95% CI, 0.11-0.93; P = .04). Conclusions. This study supports the effectiveness of bamlanivimab in reducing COVID-19-related hospitalizations in patients ≥65 or with BMI ≥35.
Author contributions. Dr. Rubin had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Chen, Nirula, Heller, BLAZE-1 Investigators. SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19, N Engl J Med
Chen, Winkler, Case, In vivo monoclonal antibody efficacy against SARS-CoV-2 variant strains, Nature
Corwin, Ender, Sahu, The efficacy of bamlanivimab in reducing emergency department visits and hospitalizations in a real-world setting, Open Forum Infect Dis
Dougan, Nirula, Azizad, BLAZE-1 Investigators. Bamlanivimab plus etesevimab in mild or moderate Covid-19, N Engl J Med
Ganesh, Philpot, Bierle, Real-world clinical outcomes of bamlanivimab and casirivimab-imdevimab among high-risk patients with mild to moderate coronavirus disease 2019, J Infect Dis
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
Jenks, Aslam, Horton, Early monoclonal antibody administration can reduce both hospitalizations and mortality in high-risk outpatients with COVID-19, Clin Infect Dis
Kumar, Wu, Sosor, Real-world experience of bamlanivimab for COVID-19: a case-control study, Clin Infect Dis
O'brien, Forleo-Neto, Musser, Covid-19 Phase 3 Prevention Trial Team. Subcutaneous REGEN-COV antibody combination to prevent Covid-19, N Engl J Med
Planas, Veyer, Baidaliuk, Reduced sensitivity of SARS-CoV-2 variant Delta to antibody neutralization, Nature
Rubin, Dryden-Peterson, Hammond, A novel approach to equitable distribution of scarce therapeutics: institutional experience implementing a reserve system for allocation of COVID-19 monoclonal antibodies, Chest, doi:10.1016/j.chest.2021.08.003
Verderese, Stepanova, Lam, Neutralizing monoclonal antibody treatment reduces hospitalization for mild and moderate COVID-19. A real-world experience, Clin Infect Dis, doi:10.1093/cid/ciab579
Webb, Buckel, Vento, Real-world effectiveness and tolerability of monoclonal antibody therapy for ambulatory patients with early COVID-19, Open Forum Infect Dis
Weinreich, Sivapalasingam, Norton, Trial Investigators. REGN-COV2, a neutralizing antibody cocktail, in outpatients with Covid-19, N Engl J Med
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