Use of Monoclonal Antibodies Reduces Death, Hospitalization Risk by More Than One-Third After COVID-19 Diagnosis
Embargoed for release until 5:00 p.m. ET on Monday 3 April 2023
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Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.
1. Use of monoclonal antibodies reduces death, hospitalization risk by more than one-third after COVID-19 diagnosis
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A cohort study of more than 2,500 people found that the use of monoclonal antibodies to treat COVID-19 within two days of receiving a positive COVID-19 test reduced their risk of hospitalization or death by 39 percent compared to persons who were eligible for monoclonal antibody treatment but did not receive it. Persons with immunocompromising conditions experienced further reduced risk. The findings are published in Annals of Internal Medicine.
The U.S. Food and Drug Administration (FDA) granted emergency use authorization to five different COVID-19 monoclonal antibody treatments at various times between 2020 and 2022. During this time, monoclonal antibody treatments were shown to have reduced COVID-19 viral load and later showed decreased rates of hospitalization and death in some at-risk patients. All five of the previously authorized treatments have since been suspended or revoked by the FDA based on in vitro evidence of evolving loss of efficacy against new COVID-19 variants. However, these treatments were revoked without the availability of randomized trials or real-world data.
Researchers from the University of Pittsburgh Medical Center conducted a hypothetical pragmatic randomized trial of 2,571 patients treated with monoclonal antibodies who were matched with data from 5,135 patients with COVID-19 who were eligible for monoclonal antibodies but did not receive them. The authors found that treatment with monoclonal antibodies within two days of COVID-19 infection was associated with an estimated 39 percent lower risk for hospitalization or death at 28 days. According to the authors, their results indicate that throughout the pandemic, early treatment with monoclonal antibody treatment significantly reduced severity of COVID-19. They also emphasize that their findings should be interpreted with the knowledge that there are currently no FDA-approved monoclonal antibody treatments for treatment of outpatients with COVID-19, and that the rapid evolution of new variants warrants timely, continuous evaluation of both monoclonal antibody and non-monoclonal antibody treatment approaches.
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2. Self-reported functional impairments, frailty associated with higher healthcare costs in Medicare beneficiaries, even after accounting for claims-based measures
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A study of more than 8,000 comprehensively characterized Medicare beneficiaries found that the addition of self-reported functional impairments and physical frailty to claims-based measures of multi-morbidity and frailty identifies large differences in spending attributable to impairments and frailty. The findings are published in Annals of Internal Medicine.
Healthcare systems are assuming increasing responsibility for the expenditures of their patients, including older adults who account for a disproportionate share of healthcare costs. To reduce future spending, these healthcare systems need to identify older adults at risk for costly care to select target populations for interventions to reduce health care burden.
Researchers from the University of Minnesota analyzed 8,165 Medicare beneficiaries who were enrolled in NIH-funded prospective cohort studies. The authors found that self-reported functional impairments and physical frailty are robustly associated with substantial additional health care costs in older adults even after accounting for claims-based measures of multimorbidity and frailty. The authors also found that claims-based models adding functional impairments and physical frailty outperformed models based on claims-derived indicators alone, resulting in better accuracy of cost prediction overall and in high-risk subpopulations. They note that persons with functional impairments or physical frailty compared to those without these geriatric syndromes had higher costs not attributable to claims-based predictors of costs, ranging from additional costs of $2354 to $11770 per year for functional impairments and from $6172 to $8532 per year for physical frailty. According to the authors, their results suggest that assessment of functional impairments and physical frailty may improve identification and characterization of older adults likely to require costly care and aid development and targeting of interventions aimed at reducing costs.
An accompanying editorial from the University of Michigan Medical School highlights the importance of predicting costs when determining how much to pay providers for their care of a defined population. While the addition of functional impairments and physical frailty results in a modest improvement in cost prediction for the overall study population, it is not yet known whether this gain in accuracy justifies the cost and effort that would be required of health systems to routinely collect data on functional status or measure physical frailty in their older patients. However, the author of the editorial acknowledges that incorporation of these measures into electronic health records, while costly, could potentially allow greater return on investment when one considers the potential for financial incentives that encourage more targeted interventions in older patients with functional impairments to prevent need for long-term care. This information could also help clinicians alter the trajectory of functional decline in older patients in situations where that remains possible.
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