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Neutralizing Monoclonal Antibody Use and COVID-19 Infection Outcomes.

Nalini Ambrose1, Alpesh Amin2,3, Brian Anderson1

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Neutralizing monoclonal antibodies (nMAbs) for COVID-19 treatment demonstrated safety and reduced emergency department visits, hospitalizations, and deaths. However, effectiveness waned during the Omicron BA.1 variant epoch, suggesting tailored risk stratification for optimal treatment decisions.

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Area of Science:

  • Infectious Diseases
  • Pharmacology
  • Public Health

Background:

  • COVID-19 treatment effectiveness and safety data are crucial for diverse populations.
  • Neutralizing monoclonal antibodies (nMAbs) are a key therapeutic option.

Purpose of the Study:

  • To assess the safety and effectiveness of nMAbs in treating COVID-19.
  • To evaluate the association of nMAbs with adverse outcomes across different SARS-CoV-2 variant epochs.

Main Methods:

  • Retrospective cohort study of 167,183 non-hospitalized patients aged 12+ with COVID-19.
  • Analysis of clinical and genomic data using propensity-adjusted marginal structural models.
  • Categorization of patient index dates into four variant epochs: pre-Delta, Delta, Delta/Omicron BA.1, and Omicron BA.1.

Main Results:

  • nMAbs were associated with reduced odds of ED visits (OR, 0.76), hospitalization (OR, 0.52), and death (OR, 0.14) within specified periods.
  • Benefits were more pronounced in unvaccinated and immunocompromised patients, and during the Delta variant epoch.
  • Effectiveness against hospitalization was not observed during the Omicron BA.1 epoch (OR, 1.29).
  • Adverse drug events were rare, occurring in 0.2% of treated patients.

Conclusions:

  • nMAb treatment for COVID-19 is safe and reduces key adverse outcomes like hospitalization and death.
  • The efficacy of nMAbs varied significantly across different SARS-CoV-2 variants, notably decreasing with Omicron BA.1.
  • Risk stratification strategies are recommended to optimize the clinical use of nMAbs.