Efficacy of olokizumab in patients with mild or moderate COVID-19 and risk factors of progression

Abstract

The COronaVIrus Disease 2019 (COVID-19) is a common infectious disease characterized by hyperactivation of the immune response and the development of a “cytokine storm” upon progression. The aim of this study was to obtain additional information about the efficacy of the drug olokizumab in comparison with the Janus kinase inhibitor upadacitinib in real clinical practice in patients with mild to moderate COVID-19 and combined risk factors for disease progression. Methods. A single-center, non-interventional, prospective study was conducted in specialized day hospital patients (n = 125) who received therapy with olokizumab ( n = 62) (64 mg once intravenously) and the Janus kinase inhibitor upadacitinib ( n = 63) (orally, according to selected dosing regimen). The primary endpoint was the frequency of hospitalizations in the 24-hour hospital over the entire observation period. We also analyzed the frequencies of intensive care unit (ICU) transfer, prescription of respyratory therapy, use of “rescue” therapy (monoclonal antibodies/therapeutic proteins acting on interleukins (IL) and their receptors: IL-6 receptor inhibitors and Janus kinase inhibitors (baricitinib, tofacitinib, upadacitinib, etc.)), mortality, dynamics of laboratory and instrumental parameters, as well as frequency of negative and positive changes according to the clinical progression scale of the World Health Organization. Results. All study subjects showed rapid clinical improvement and recovery. Patients in both groups did not experience any negative clinical events, such as admission to a 24-hour hospital, prescription of respyratory therapy, use of “rescue” therapy, etc. Thus, the hyperinflammatory reaction and adverse clinical outcomes are effectively prevented by the timely use of both drugs. Those who received olokizumab had slightly higher levels of C-reactive protein (CRP) at baseline than those who received upadacitinib ( p < 0.001). The median CRP value returned to normal on the 4 th day in both groups. Patients treated with olokizumab showed a more pronounced change in CRP levels relative to baseline values. A similar trend was also established in body temperature. Conclusion. The study confirmed that early administration of olokizumab in patients with mild to moderate COVID-19 with several risk factors for the severe course is as effective a method of preemptive anti-inflammatory therapy as the use of Janus kinase inhibitors but more stronger suppression of markers and symptoms of intoxication.