Bamlanivimab Efficacy in Older and High-BMI Outpatients With COVID-19 Selected for Treatment in a Lottery-Based Allocation Process

Rubin, Edward L.; Boiarsky, Jonathan; Canha, Lauren; Giobbie‐Hurder, Anita; Liu, Mofei; Townsend, Matthew J.; Dougan, Michael

doi:10.1093/ofid/ofab546

Cited by 7 publications

(7 citation statements)

References 11 publications

(14 reference statements)

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“…The COVID variants of interest in the studies included 21C (Epsilon), 20E (EU1), and B.1.1.7 (Alpha). Seven additional studies were identified in January 2023, and these were included in our analysis ( Chilimuri et al, 2022 ; Cooper et al, 2021 ; Iqbal et al, 2021 ; Leavitt et al, 2021 ; Murillo et al, 2022 ; Rainwater-Lovett et al, 2021 ; Rubin et al, 2021 ).…”

Section: Resultsmentioning

confidence: 99%

Effects of bamlanivimab alone or in combination with etesevimab on subsequent hospitalization and mortality in outpatients with COVID-19: a systematic review and meta-analysis

Tai

Lee

Chi

et al. 2023

PeerJ

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Background Coronavirus disease 2019 (COVID-19) has caused an enormous loss of life worldwide. The spike protein of the severe acute respiratory syndrome coronavirus 2 is the cause of its virulence. Bamlanivimab, a recombinant monoclonal antibody, has been used alone or in combination with etesevimab to provide passive immunity and improve clinical outcomes. A systematic review and meta-analysis was conducted to investigate the therapeutic effects of bamlanivimab with or without etesevimab (BAM/ETE) treatment. Methods Our study was registered in PROSPERO (registry number CRD42021270206). We searched the following electronic databases, without language restrictions, until January 2023: PubMed, Embase, medRxiv, and the Cochrane database. A systematic review and meta-analysis was conducted based on the search results. Results Eighteen publications with a total of 28,577 patients were identified. Non-hospitalized patients given bamlanivimab with or without etesevimab had a significantly lower risk of subsequent hospitalization (18 trials, odds ratio (OR): 0.37, 95% confidence interval (CI): [0.29–0.49], I2: 69%; p < 0.01) and mortality (15 trials, OR: 0.27, 95% CI [0.17–0.43], I2: 0%; p = 0.85). Bamlanivimab monotherapy also reduced the subsequent risk of hospitalization (16 trials, OR: 0.43, 95% CI [0.34–0.54], I2: 57%; p = 0.01) and mortality (14 trials, OR: 0.28, 95% CI [0.17–0.46], I2: 0%; p = 0.9). Adverse events from these medications were uncommon and tolerable. Conclusions In this meta-analysis, we found the use of bamlanivimab with or without etesevimab contributed to a significantly-reduced risk of subsequent hospitalization and mortality in non-hospitalized COVID-19 patients. However, resistance to monoclonal antibodies was observed in COVID-19 variants, resulting in the halting of the clinical use of BAM/ETE. Clinicians’ experiences with BAM/ETE indicate the importance of genomic surveillance. BAM/ETE may be repurposed as a potential component of a cocktail regimen in treating future COVID variants.

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Section: Resultsmentioning

confidence: 99%

Effects of bamlanivimab alone or in combination with etesevimab on subsequent hospitalization and mortality in outpatients with COVID-19: a systematic review and meta-analysis

Tai

Lee

Chi

et al. 2023

PeerJ

View full text Add to dashboard Cite

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“…21 It is noteworthy that other investigators have addressed this limitation by examining outcomes in patients for whom, due to supply limitations, a lottery-based approach to equitable patient allocation was applied. 22 However, some lotteries were more restrictive than the EUA qualifications, restricting to either high BMI ≥35 or age ≥65 patients. 22 Collectively, varied approaches and investigations corroborate the benefit of neutralizing monoclonal antibody therapy such as bamlanivimab for those periods of time when viral variants in circulation demonstrate susceptibility.…”

Section: Discussionmentioning

confidence: 99%

“…22 However, some lotteries were more restrictive than the EUA qualifications, restricting to either high BMI ≥35 or age ≥65 patients. 22 Collectively, varied approaches and investigations corroborate the benefit of neutralizing monoclonal antibody therapy such as bamlanivimab for those periods of time when viral variants in circulation demonstrate susceptibility.…”

Section: Discussionmentioning

confidence: 99%

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A Propensity-Matched Cohort Assessing Impact of a Neutralizing Monoclonal Antibody in Mild-to-Moderate Coronavirus Disease 2019

Abbas

Farhat

Hammoud

et al. 2023

J Intensive Care Med

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Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoaV-2) is responsible for the coronavirus disease 2019 (COVID-19) pandemic. In randomized clinical trials, patients who were treated with the anti-spike monoclonal antibody bamlanivimab had fewer COVID-19-related hospitalizations or emergency department (ED) visits than the control group. Methods: A retrospective cohort was assembled across a multisite healthcare system between November 20, 2020 and March 31, 2021. Ambulatory COVID-19 patients treated with bamlanivimab (n = 209) were propensity score matched without replacement (1:1) to a pool of 1024 eligible control patients who received similar care without bamlanivimab. The primary endpoint was all-cause mortality or admission at 30 days. Secondary endpoints included hospitalization, critical care admission, oxygenation requirements, and infusion-related reactions. Propensity score matching (PSM) analysis was used to assess the effect of bamlanivimab infusion on the composite endpoint and secondary endpoints. Results: A total of n = 209 matched patients were included in each arm of the study. The absolute standardized difference ( stddiff) was calculated and indicated a balance between the groups. Almost all variables had a stddiff of less than 0.10, except for respiratory rate (RR) ( stddiff = −0.11). For the primary composite endpoint of the matched cohort, 10.1% (n = 21) of patients in the intervention group were hospitalized or deceased within 30-day postbamlanivimab infusion versus 27.8% (n = 58) in the control group (adjusted odds ratio [aOR]: 0.29, 95% confidence interval [CI]: 0.17 to 0.51, P < .001). Conclusion: Patients with ambulatory COVID-19 who received bamlanivimab in the outpatient setting had a statistically significant reduction on the odds of admission postinfusion. Despite bamlanivimab's lack of efficacy on newer SARS-CoV-2 variants, this study demonstrates that neutralizing monoclonal antibodies can be effective against specific variants. If variant identification becomes a more accessible tool in outpatient centers or EDs, more targeted therapeutic options may be considered.

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“…The Food and Drug Administration has issued Emergency Use Authorization (EUA) for multiple monoclonal antibodies (“mAbs”) for outpatients with COVID-19 and mild to moderate symptoms who are at high risk for severe disease [ 1–3 ] based on evidence that the early administration of mAbs significantly reduces the need for hospitalization [ 4–6 ]. Multiple studies have confirmed the effectiveness of mAbs in reducing rates of hospitalization under real-world conditions [ 7 , 8 ]. The current EUAs for bamlanivimab and etesevimab, casirivimab and imdevimab, and sotrovimab contain a list of qualifying risk factors for severe disease.…”

mentioning

confidence: 99%

Performance of a Triage Protocol for Monoclonal Antibodies in a Mixed Vaccinated and Unvaccinated Cohort of COVID-19 Patients Treated With Intravenous Infusion or Subcutaneous Injection

Rubin

Liu

Giobbie‐Hurder

et al. 2022

Open Forum Infectious Diseases

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Background Several monoclonal antibodies (mAbs) have been shown to reduce rates of hospitalization in patients with Covid-19 who have risk factors for severe disease. Due to capacity constraints, many health systems have been unable to provide mAbs to all eligible patients. There is little evidence regarding the performance of triage protocols for allocation or the relative effectiveness of subcutaneous administration versus intravenous infusion. Methods Retrospective cohort study of 1063 patients with Covid-19 consecutively referred for monoclonal antibody therapy in a single large academic health care system, who were prioritized for mAb therapy using an allocation protocol grouping patients by risk. Results A triage protocol prioritizing patients who were not fully vaccinated and at high risk of severe Covid-19 plus patients who were heavily immunosuppressed performed well in terms of differentiating between groups of patients by risk of severe disease. The number needed to treat (NNT) to prevent one hospitalization was 4.4 for the highest priority group, 8.5 for the next highest priority group, and 21.7 for the third highest priority group. There was no significant correlation between route of administration and hospitalization for symptoms related to Covid-19 (OR 1.26 in the IV group compared to the subcutaneous group, 95% CI [0.56-2.8], P =0.58). Conclusions This study demonstrates that triaging mAbs for patients with Covid-19 by risk can optimize benefit in terms of reducing rates of hospitalization and that rates of hospitalization may be no different between patients treated with subcutaneous injection and patients treated with intravenous infusion.

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Bamlanivimab Efficacy in Older and High-BMI Outpatients With COVID-19 Selected for Treatment in a Lottery-Based Allocation Process

Cited by 7 publications

References 11 publications

Effects of bamlanivimab alone or in combination with etesevimab on subsequent hospitalization and mortality in outpatients with COVID-19: a systematic review and meta-analysis

Effects of bamlanivimab alone or in combination with etesevimab on subsequent hospitalization and mortality in outpatients with COVID-19: a systematic review and meta-analysis

A Propensity-Matched Cohort Assessing Impact of a Neutralizing Monoclonal Antibody in Mild-to-Moderate Coronavirus Disease 2019

Performance of a Triage Protocol for Monoclonal Antibodies in a Mixed Vaccinated and Unvaccinated Cohort of COVID-19 Patients Treated With Intravenous Infusion or Subcutaneous Injection

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