Impact of monoclonal antibody treatment on hospitalization and mortality among non-hospitalized adults with SARS-CoV-2 infection

Abstract

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.

Intravenous bamlanivimab use associates with reduced hospitalization in high-risk patients with mild to moderate COVID-19

“…As prior studies have suggested that patients with medical comorbidities are at higher risk of severe and critical illness, early treatment with bamlanivimab may have mitigated this progression. (11,18,19) Due to the evolution of SARS-CoV-2 variants, bamlanivimab is no longer authorized for use as monotherapy. Despite this, the results of this study which showed the real-world efficacy of bamlanivimab monotherapy in the prevention of hospital admission and other serious clinical outcomes, provides the proof of concept that treatment with neutralizing antibodies is an effective strategy to mitigate the current COVID-19 pandemic.…”

“…(8)(9)(10) Upon the issuance of the EUA, institutions across the US established infusion facilities for the administration of monoclonal antibodies. (11)(12)(13)(14) The Mayo Clinic developed its dedicated infusion facilities and assembled multidisciplinary teams to coordinate monoclonal antibody infusions to patients with coronavirus disease-19 (COVID- 19) who are eligible under the EUA. (7,15) This study was conducted to analyze the association of bamlanivimab monotherapy with clinical outcomes in high-risk patients with mild to moderate COVID-19.…”

An overview of the preclinical discovery and development of bamlanivimab for the treatment of novel coronavirus infection (COVID-19): reasons for limited clinical use and lessons for the future

“…In an early matched study on 468 patients by Bariola et al, patients receiving bamlanivimab were less likely to experience hospitalization or mortality (OR 0.31) and hospitalization or emergency department visit without hospitalization (OR 0.50). The impact of bamlanivimab was more pronounced in prevention of hospitalization (among all age groups, OR 0.35) than mortality or emergency department visit without hospitalization, and most strongly associated with patients age 65 years and older (primary outcome OR 0.28) [ 55 ].…”

Staffing and Capacity Planning for SARS-CoV-2 Monoclonal Antibody Infusion Facilities: A Performance Estimation Calculator based on Discrete-Event Simulations

“…In November 2020, the Food and Drug Administration issued emergency use authorizations for monoclonal antibody (mAb) monotherapy bamlanivimab and combination therapy casirivimab/imdevimab to treat COVID-19 among individuals at high risk for progressing to severe disease [5]. These mAb treatments were shown to be effective for preventing progression of disease and COVID-19-associated hospitalizations [6,7]. Given that a significant number of individuals remain at risk for COVID-19 in the U.S. [8], mAb treatments will continue to be critical for saving lives and reducing COVID-19 morbidity and mortality [9,10].…”