Reactions and COVID-19 disease progression following SARS-CoV-2 monoclonal antibody infusion

Abstract

SARS-CoV-2 monoclonal antibodies (mAbs) have been proposed as a treatment for mild to moderate COVID-19, with favorable outcomes reported in clinical trials and an emergency use authorization granted by the Food and Drug Administration. Real-world data remain limited, however, and thus this analysis presents findings from over 6,500 outpatient administrations of mAb at facilities affiliated with a large healthcare organization in the United States. Within 48 hours of mAb infusion, 15.6% (1,043) of patients received a drug that was indicative of a possible reaction to the infusion; the majority of these were mild (e.g., acetaminophen). Approximately 5.2% of patients who received mAb (n=347) had a post-infusion emergency department visit or admission for COVID-19 disease progression. The results of this analysis indicate that patients who receive mAb have a low likelihood of both an immediate negative reaction to the treatment as well as future inpatient admission related to COVID-19 disease progression.

Efficacy and safety of sotrovimab in patients with COVID‐19: A rapid review and meta‐analysis

“…Anti-SARS-CoV-2 mABs therapies are generally well-tolerated in patients suffering from COVID-19. 47,[54][55][56][57] Our study has some important limitations. First, a significant publication bias was detected in the present meta-analysis.…”

“…showed that neutralising mABs are safe and not associated with a higher risk of adverse events compared to placebo. Anti‐SARS‐CoV‐2 mABs therapies are generally well‐tolerated in patients suffering from COVID‐19 47,54–57 …”

“…Anti‐SARS‐CoV‐2 mABs therapies are generally well‐tolerated in patients suffering from COVID‐19. 47 , 54 , 55 , 56 , 57 …”

Immunotherapy and CRISPR Cas Systems: Potential Cure of COVID-19?

“… 99 Furthermore another study evaluation of findings from over 6500 outpatient with monoclonal antibodies (mAbs) including bamlanivimab/etesevimab, and casirivimab/imdevimab led to the conclusion that they protect individuals against mild to moderate COVID-19, inhibits further progression of the disease in most cases. 100 A study showed that Imdevimab neutralized B.1.351 lineage pseudoviruses containing N501Y, K417N, and E484K mutations, while Casirivimab showed partial neutralizing effect against them. 101 In another study it was concluded that bamlanivimab, casirivimab, and imdevimab possess the capacity to effectively neutralize authentic SARS-CoV-2, including variant B.1.1.7 (Alpha), however variants B.1.351 (Beta) and P.2 (Zeta) were resistant to bamlanivimab and partly resistant to casirivimab as they carry the E484K mutation.…”

Effectiveness of monoclonal antibody therapy for COVID-19 patients using a risk scoring system

“…Adverse events, such as nausea, diarrhoea and headache, showed very low rates in a randomised controlled trial, indicating the safety of monoclonal antibody therapy [ 14 ]. In addition, only 0.9% of patients who received therapy required emergency room admission because of infusion reaction in a clinical trial [ 15 ]. In our study, similar to previous reports, only two patients reported transient adverse events of REGN-CoV-2 (headache and neck rash), and 2.6% of the patients complained of postadministration fever that improved within 24 h. There were no immediate infusion reaction and serious adverse events.…”