Levilimab, a monoclonal antibody to IL-6 receptors, in COVID-19

Abstract

Levilimab, a monoclonal antibody interacting with soluble and mebrane bound IL-6 receptors, was recently approved in Russia for the treatment of acute respiratory distress syndrome in COVID-19 patients. Efficacy and favorable safety profile of levilimab were shown in the randomised doubleblind placebo controlled CORONA trial in 206 patients with COVID-19 associated pneumonia, who had at least one criteria of the disease severity, that is, increased respiration rate, reduced SpO2 (≤93%) or PaO2 /FiO2 (≤300 mm Hg), progressive lung disease, etc. The primary end-point of this study was the percentage of patients with stable improvement by ordinal scale (without a need in rescue levilimab injection) at day 14. Stable improvement was achieved in 63.1% and 42.7% of patients in the levilimab and placebo groups, respectively (р=0.0017), and this difference was consistent at the end of 30-day follow-up. Analysis of various secondary end-points, such as a need in rescue open-label levilimab or admission to ICU, confirmed efficacy of IL-6 inhibitor in patients with COVID -19. IL-6 inhibition was not associated with a higher risk of opportunistic infections. The authors present the case of successful levilimab administration in hospitalized patient with hypoxia and systemic inflammation and discuss the practical issues of IL-6 inhibitors use in COVID-19 patients.