Impact of monoclonal antibody treatment on hospitalization and mortality among non-hospitalized adults with SARS-CoV-2 infection
J Ryan Bariola, PharmD Erin K Mccreary, MD Richard J Wadas, PhD Kevin E Kip, MD Oscar C Marroquin, MSN Tami Minnier, BS Stephen Koscumb, BS Kevin Collins, MD Mark Schmidhofer, Judith A Shovel, MT Mary Kay Wisniewski, Colleen Sullivan, MD Donald M Yealy, MD MPH David A Nace, MD MPH David T Huang, MD Ghady Haidar, Tina Khadem, MS Kelsey Linstrum, MD MSc Christopher W Seymour, MS Stephanie K Montgomery, MD MPH FRCP Derek C Angus, MD SM Graham M Snyder
doi:10.1101/2021.03.25.21254322
Background: Monoclonal antibody (mAb) treatment may prevent complications of COVID-19. We sought to quantify the impact of bamlanivimab monotherapy on hospitalizations and mortality, as well as Emergency Department (ED) visits without hospitalization, among outpatients at high risk of COVID-19 complications.
Methods: We compared patients receiving mAb to patients who met criteria but did not receive mAb from December 2020 through March 2021. The study population selection used propensity scores to match 1:1 by likelihood to receive mAb. The primary outcome was hospitalization or all-cause mortality within 28 days; the secondary outcome was hospitalization or ED visit without hospitalization within 28 days. Odds ratios (OR) calculation used logistic regression modeling including propensity score and mAb receipt predictors.
Results: The study population included 234 patients receiving mAb and 234 matched comparator patients not receiving mAb. Patients receiving mAb were less likely to experience hospitalization or mortality (OR 0.31, 95% confidence interval [95%CI] 0.17-0.56, p=0.00001) and hospitalization or ED visit without hospitalization (OR 0.50, 95%CI 0.43-0.83, p=0.007). The impact of mAb was more pronounced in prevention of hospitalization (among all age groups, OR 0.35, 95%CI 0.19-0.66, p=0.001) than mortality or ED visit without hospitalization, and most strongly associated with patients age 65 years and older (primary outcome OR 0.28, 95%CI 0.14-0.56, p=0.0003).
Conclusions : Bamlanivimab monotherapy was associated with reduction in the composite outcome of hospitalizations and mortality in patients with mild-moderate COVID-19. The benefit may be strongest in preventing hospitalization in patients ages 65 years or older. . CoV016; Eli Lilly), casirivimab 1,200mg (REGN10933; Regeneron), imdevimab 1,200mg (REGN10987). Several clinical trials currently evaluate mAbs for prevention or treatment of COVID-19; however, real-world data are limited, and the role of mAbs for patients with COVID-19 remains controversial. 3, 5 Use of mAb therapy is low in the United States despite widespread drug availability due to lack of robust efficacy data, operational challenges with outpatient infusions, and patient access issues. 6 Our health system established a mAb program in November 2020 to decrease COVID-19-related complications for patients with mild-moderate illness and expand access to care for underserved patients with COVID-19. Initially, only bamlanivimab monotherapy was available; our evaluation and distribution process has been described elsewhere. 7 This study quantifies the impact of bamlanivimab monotherapy on hospitalizations, mortality, and Emergency Department (ED) visits among outpatients at high risk of progressing to severe COVID-19. We also explored whether patient age, body mass index, and timing of infusions relative to initial diagnosis had any association with response to therapy.
METHODS
Study Setting .
Conflict of Interest Disclosure: None of the authors received any payments or influence from a third-party source for the work presented, and none report any potential conflicts of interest.
SUPPLEMENTAL MATERIALS
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doi:10.1056/NEJMoa2035002DOI record:
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"abstract": "<jats:title>ABSTRACT</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Monoclonal antibody (mAb) treatment may prevent complications of COVID-19. We sought to quantify the impact of bamlanivimab monotherapy on hospitalizations and mortality, as well as Emergency Department (ED) visits without hospitalization, among outpatients at high risk of COVID-19 complications.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We compared patients receiving mAb to patients who met criteria but did not receive mAb from December 2020 through March 2021. The study population selection used propensity scores to match 1:1 by likelihood to receive mAb. The primary outcome was hospitalization or all-cause mortality within 28 days; the secondary outcome was hospitalization or ED visit without hospitalization within 28 days. Odds ratios (OR) calculation used logistic regression modeling including propensity score and mAb receipt predictors.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The study population included 234 patients receiving mAb and 234 matched comparator patients not receiving mAb. Patients receiving mAb were less likely to experience hospitalization or mortality (OR 0.31, 95% confidence interval [95%CI] 0.17-0.56, p=0.00001) and hospitalization or ED visit without hospitalization (OR 0.50, 95%CI 0.43-0.83, p=0.007). The impact of mAb was more pronounced in prevention of hospitalization (among all age groups, OR 0.35, 95%CI 0.19-0.66, p=0.001) than mortality or ED visit without hospitalization, and most strongly associated with patients age 65 years and older (primary outcome OR 0.28, 95%CI 0.14-0.56, p=0.0003).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Bamlanivimab monotherapy was associated with reduction in the composite outcome of hospitalizations and mortality in patients with mild-moderate COVID-19. The benefit may be strongest in preventing hospitalization in patients ages 65 years or older.</jats:p></jats:sec>",
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