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

Abstract

Background: Clinical data to support the use of bamlanivimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) is needed.Methods: 2,335 patients who received single-dose bamlanivimab infusion between November 12, 2020 to February 17, 2021 were compared with a propensity-matched control of 2,335 untreated patients with mild to moderate COVID-19 at Mayo Clinic facilities across 4 states.The primary outcome was the rate of hospitalization at days 14, 21 and 28. Results:The median age of the population was 63 years-old; 47.3% of the bamlanivimabtreated cohort were ≥65 years; 49.3% were female. High-risk characteristics included hypertension (54.2%), body mass index ≥35 (32.4%), diabetes mellitus (26.5%), chronic lung disease (25.1%), malignancy (16.6%), and renal disease (14.5%). Patients who received bamlanivimab had lower all-cause hospitalization rates at days 14 (1.5% vs 3.5%; Risk Ratio [RR], 0.41), 21 (1.9% vs 3.9%; RR, 0.49), and 28 (2.5% vs 3.9%; RR, 0.63). Secondary exploratory outcomes included lower intensive care unit admission rates at days 14 (0.14% vs 1%; RR, 0.14), 21 (0.25% vs 1%; RR: 0.25) and 28 (0.56% vs 1.1%; RR: 0.51), and lower allcause mortality at days 14 (0% vs 0.33%), 21 (0.05% vs 0.4%; RR,0.13) and 28 (0.11% vs 0.44%; RR, 0.26). Adverse events were uncommon with bamlanivimab, occurring in 19/2355, most commonly fever (n=6), nausea (n=5), and lightheadedness (n=3).Conclusions: Among high-risk patients with mild to moderate COVID-19, treatment with bamlanivimab was associated with a statistically significant lower rate of hospitalization, ICU admission and mortality, compared with usual care.

Successful early use of anti‐SARS‐CoV‐2 monoclonal neutralizing antibodies in SARS‐CoV‐2 infected hematological patients – A Czech multicenter experience

“…Similar results were obtained by a large retrospective case‐control study noting all‐cause mortality reduction at day 21 among a group of high‐risk general patients who received bamlanivimab compared to a control group with mild to moderate COVID‐19 (0.05% vs. 0.4%; Risk Ratio‐RR, 0.13). 3 Furthermore, another real‐life clinical setting confirmed that NmAb (bamlanivimab or casirivimab/imdevimab) treatment significantly decreased hospital in‐patient status among a general population cohort with mild to moderate COVID‐19, especially when treatment was initiated ≤4 days after symptom onset. 4 …”

“… 1 , 2 Similar results were obtained via retrospective case‐control studies regarding frequency reduction of hospitalizations. 3 , 4 …”

The impact of neutralizing monoclonal antibodies on the outcomes of COVID‐19 outpatients: A systematic review and meta‐analysis of randomized controlled trials

“… 11 , 12 Recently, several randomized controlled trials (RCTs) have been conducted to assess the clinical efficacy of neutralizing mABs for COVID‐19 patients, and they have shown promising results. 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 We conducted this systematic review and meta‐analysis of RCTs to provide robust and up‐to‐date evidence of the clinical efficacy and safety of neutralizing mABs for COVID‐19 outpatients.…”

Breakthrough COVID‐19 after SARS‐CoV‐2 vaccination in solid organ transplant recipients: An analysis of symptomatic cases and monoclonal antibody therapy

“…9,10 While these early studies did not initially evaluate transplant recipients, later observational studies found similar results in SOT recipients 11,12 and other high-risk populations. [13][14][15][16] In the setting of prior COVID-19 vaccination, however, it is less clear how effective these monoclonal antibody therapies may be.…”

“…Initial studies found this antibody therapy to reduce hospitalization and medically attended visits among patients with high‐risk comorbidities 9,10 . While these early studies did not initially evaluate transplant recipients, later observational studies found similar results in SOT recipients 11,12 and other high‐risk populations 13–16 . In the setting of prior COVID‐19 vaccination, however, it is less clear how effective these monoclonal antibody therapies may be.…”