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. 2021 Dec;10(4):2479-2488.
doi: 10.1007/s40121-021-00525-4. Epub 2021 Aug 25.

Efficacy of Bamlanivimab/Etesevimab and Casirivimab/Imdevimab in Preventing Progression to Severe COVID-19 and Role of Variants of Concern

Marco Falcone  1 , Giusy Tiseo  2 , Beatrice Valoriani  3 , Chiara Barbieri  2 , Sara Occhineri  2 , Paola Mazzetti  4 , Maria Linda Vatteroni  4 , Lorenzo Roberto Suardi  2 , Niccolò Riccardi  2 , Mauro Pistello  4   5 , Danilo Tacconi  3 , Francesco Menichetti  2
Affiliations

Efficacy of Bamlanivimab/Etesevimab and Casirivimab/Imdevimab in Preventing Progression to Severe COVID-19 and Role of Variants of Concern

Marco Falcone et al. Infect Dis Ther. 2021 Dec.

Abstract

Introduction: The aim of this study was to evaluate the risk of hospitalization or death in patients infected by SARS-CoV2 variants of concern (VOCs) receiving combinations of monoclonal antibodies (mAbs), bamlanivimab/etesevimab or casirivimab/imdevimab.

Methods: Observational prospective study conducted in two Italian hospitals (University Hospital of Pisa and San Donato Hospital, Arezzo) including consecutive outpatients with COVID-19 who received bamlanivimab/etesevimab or casirivimab/imdevimab from March 20th to May 10th 2021. All patients were at high risk of COVID-19 progression according to FDA/AIFA recommendations. Patients were divided into two study groups according to the infecting viral strain (VOCs): Alpha and Gamma group. The primary endpoint was a composite of hospitalization or death within 30 days from mAbs infusion. A Cox regression multivariate analysis was performed to identify factors associated with the primary outcome in the overall population.

Results: The study included 165 patients: 105 were infected by the VOC Alpha and 43 by the VOC Gamma. In the Alpha group, no differences in the primary endpoint were observed between patients treated with bamlanivimab/etesevimab or casirivimab/imdevimab. Conversely, in the Gamma group, a higher proportion of patients treated with bamlanivimab/etesevimab met the primary endpoint compared to those receiving casirivimab/imdevimab (55% vs. 17.4%, p = 0.013). On multivariate Cox-regression analysis, the Gamma variant and days from symptoms onset to mAbs infusion were factors independently associated with higher risk of hospitalization or death, while casirivimab/imdevimab was protective (HR 0.33, 95% CI 0.13-0.83, p = 0.019).

Conclusions: In patients infected by the SARS-CoV-2 Gamma variant, bamlanivimab/etesevimab should be used with caution because of the high risk of disease progression.

Keywords: Bamlanivimab/etesevimab; COVID-19; Casirivimab/imdevimab; Monoclonal antibodies; SARS-CoV-2; Variants of concern.

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Figures

Fig. 1
Fig. 1
Study flow chart. WT wild-type
Fig. 2
Fig. 2
Survival curves of patients with the Alpha (A) and those with the Gamma (B) VOC according to exposure variable (bamlanivimab/etesevimab or casirivimab/imdevimab). VOC variant of concern, mAbs monoclonal antibodies, Bamla/ete bamlanivimab/etesevimab, Casi/imd casirivimab/imdevimab
See this image and copyright information in PMC

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