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Real-World Experience of Bamlanivimab for Coronavirus Disease 2019 (COVID-19): A Case-Control Study
Rebecca N Kumar1, En-Ling Wu1, Valentina Stosor1,2
1Division of Infectious Diseases, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Insights
Real-world data shows bamlanivimab significantly reduced COVID-19 hospitalizations in high-risk patients. Fewer comorbidities also protected against severe outcomes, highlighting bamlanivimab
Area of Science:
- Infectious Diseases
- Pharmacology
- Public Health
Background:
- Coronavirus disease 2019 (COVID-19) poses a significant threat to healthcare systems globally.
- Anti-spike monoclonal antibodies, such as bamlanivimab, have shown promise in clinical trials for reducing COVID-19 hospitalizations.
- Real-world evidence on the effectiveness of bamlanivimab in preventing severe COVID-19 outcomes is limited.
Purpose of the Study:
- To evaluate the real-world effectiveness of bamlanivimab in preventing hospitalization among high-risk, non-hospitalized patients with COVID-19.
- To compare hospitalization rates between patients who received bamlanivimab and those who did not, despite being referred for treatment.
Main Methods:
- A retrospective case-control study was conducted involving non-hospitalized patients aged 18+ with positive SARS-CoV-2 tests and risk factors for severe COVID-19.
- Cases received bamlanivimab under emergency use authorization, while controls had a referral but did not receive the drug.
- The primary outcome was the 30-day hospitalization rate, analyzed using descriptive statistics and multivariable logistic regression.
Main Results:
- Patients receiving bamlanivimab had a significantly lower 30-day hospitalization rate (7.3%) compared to controls (20.0%), with a number needed to treat of 8.
- Logistic regression indicated that not receiving bamlanivimab and having more comorbidities were independently associated with increased odds of hospitalization.
- The study included 218 cases (bamlanivimab recipients) and 185 controls between November 30, 2020, and January 19, 2021.
Conclusions:
- Real-world data indicates that ambulatory patients with COVID-19 who received bamlanivimab experienced lower 30-day hospitalization rates compared to controls.
- Receipt of bamlanivimab and having fewer comorbidities were identified as protective factors against hospitalization.
- This study supports the potential benefit of bamlanivimab in preventing severe outcomes in high-risk COVID-19 patients outside of clinical trial settings.
Background:
Coronavirus disease 2019 (COVID-19) has strained healthcare systems with patient hospitalizations and deaths. Anti-spike monoclonal antibodies, including bamlanivimab, have demonstrated reduction in hospitalization rates in clinical trials, yet real-world evidence is lacking.
Methods:
We conducted a retrospective case-control study across a single healthcare system of nonhospitalized patients, age 18 years or older, with documented positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing, risk factors for severe COVID-19, and referrals for bamlanivimab via emergency use authorization. Cases were defined as patients who received bamlanivimab; contemporary controls had a referral order placed but did not receive bamlanivimab. The primary outcome was 30-day hospitalization rate from initial positive SARS-CoV-2 polymerase chain reaction (PCR). Descriptive statistics, including χ 2 and Mann-Whitney U test, were performed. Multivariable logistic regression was used for adjusted analysis to evaluate independent associations with 30-day hospitalization.
Results:
Between 30 November 2020 and 19 January 2021, 218 patients received bamlanivimab (cases), and 185 were referred but did not receive drug (controls). Thirty-day hospitalization rate was significantly lower among patients who received bamlanivimab (7.3% vs 20.0%, risk ratio [RR] 0.37, 95% confidence interval [CI]: .21-.64, P < .001), and the number needed to treat was 8. On logistic regression, odds of hospitalization were increased in patients not receiving bamlanivimab and with a higher number of pre-specified comorbidities (odds ratio [OR] 4.19 ,95% CI: 1.31-2.16, P < .001; OR 1.68, 95% CI: 2.12-8.30, P < .001, respectively).
Conclusions:
Ambulatory patients with COVID-19 who received bamlanivimab had a lower 30-day hospitalization than control patients in real-world experience. We identified receipt of bamlanivimab and fewer comorbidities as protective factors against hospitalization.Bamlanivimab's role in preventing hospitalization associated with coronavirus disease 2019 (COVID-19) remains unclear. In a real-world, retrospective study of 403 high-risk, ambulatory patients with COVID-19, receipt of bamlanivimab compared to no monoclonal antibody therapy was associated with lower 30-day hospitalization.
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