Abstract
This study aimed to compare the clinical progression of COVID-19 in high-risk outpatients treated with the monoclonal antibodies (mAb) bamlanivimab, bamlanivimab-etesevimab and casirivimab-imdevimab. This is an observational, multi-centre, prospective study conducted from 18 March to 15 July 2021 in eight Italian tertiary-care hospitals including mild-to-moderate COVID-19 outpatients receiving bamlanivimab (700 mg), bamlanivimab-etesevimab (700-1400 mg) or casirivimab-imdevimab (1200-1200 mg). All patients were at high risk of COVID-19 progression according to Italian Medicines Agency definitions. In a patient subgroup, SARS-CoV-2 variant and anti-SARS-CoV-2 serology were analysed at baseline. Factors associated with 28-day all-cause hospitalisation were identified using multivariable multilevel logistic regression (MMLR) and summarised with adjusted odds ratio (aOR) and 95% confidence interval (CI). A total of 635 outpatients received mAb: 161 (25.4%) bamlanivimab, 396 (62.4%) bamlanivimab-etesevimab and 78 (12.2%) casirivimab-imdevimab. Ninety-five (15%) patients received full or partial SARS-CoV-2 vaccination. The B.1.1.7 (Alpha) variant was detected in 99% of patients. Baseline serology showed no significant differences among the three mAb regimen groups. Twenty-eight-day all-cause hospitalisation was 11.3%, with a significantly higher proportion (p 0.001) in the bamlanivimab group (18.6%), compared to the bamlanivimab-etesevimab (10.1%) and casirivimab-imdevimab (2.6%) groups. On MMLR, aORs for 28-day all-cause hospitalisation were significantly lower in patients receiving bamlanivimab-etesevimab (aOR 0.51, 95% CI 0.30-0.88 p 0.015) and casirivimab-imdevimab (aOR 0.14, 95% CI 0.03-0.61, p 0.009) compared to those receiving bamlanivimab. No patients with a history of vaccination were hospitalised. The study suggests differences in clinical outcomes among the first available mAb regimens for treating high-risk COVID-19 outpatients. Randomised trials are needed to compare efficacy of mAb combination regimens in high-risk populations and according to circulating variants.
Keywords: Bamlanivimab-etesevimab, casirivimab-imdevimab; Mild-to-moderate COVID-19 outpatients; Monoclonal antibody treatments for COVID-19; SARS-CoV-2 early treatments.
【저자키워드】 Bamlanivimab-etesevimab, casirivimab-imdevimab, Mild-to-moderate COVID-19 outpatients, Monoclonal antibody treatments for COVID-19, SARS-CoV-2 early treatments., 【초록키워드】 COVID-19, SARS-CoV-2, Efficacy, vaccination, serology, hospital, Prospective Study, monoclonal antibody, variant, SARS-CoV-2 variant, progression, monoclonal antibodies, anti-SARS-CoV-2, clinical outcomes, bamlanivimab, Clinical outcome, Medicine, Casirivimab, Imdevimab, B.1.1.7, etesevimab, Patient, Logistic regression, hospitalisation, patients, SARS-CoV-2 vaccination, mAb, antibody treatment, Outpatient, high-risk population, Mild-to-moderate, high risk, regimen, (alpha, COVID-19 progression, Randomised trial, Factor, adjusted odds ratio, no significant differences, 95% CI, no significant difference, significant differences, 95% confidence interval, significantly lower, COVID-19 outpatients, randomised trials, circulating variants, hospitalised, Italian, Baseline serology, Monoclonal antibody treatments, patient subgroup, multivariable, proportion, conducted, eight, receiving, analysed, treated, significantly higher, groups, baseline, combination regimen, COVID-19 outpatient, The B.1.1.7, 【제목키워드】 Efficacy, prospective cohort study, Moderate COVID-19, clinical, Patient, Mild, disease, regimen, non-hospitalised,