Olokizumab reduces the risks of death in hospitalized patients with moderate and severe COVID-19

Abstract

Aim – to evaluate the efficacy and safety of olokizumab in hospitalized patients with moderate to severe coronavirus disease COVID-19.

Material and methods. A multicenter non-interventional retrospective study of olokizumab treatment in hospitalized patients with COVID-19 was conducted. The initial population in this study included 2926 patients with COVID-19. Patients with moderate or severe disease who were taking corticosteroids as part of standard therapy were selected for this analysis. The final population was 1738 patients. A test group (standard therapy: corticosteroids, antiviral, pathogenetic or symptomatic therapy in combination with olokizumab) and a comparison group (standard therapy only) were formed. Each group included 869 patients. The primary end point was all-cause mortality from the start of anti-inflammatory therapy to the end of follow-up. We also analyzed the incidence of transfer and the length of stay of patients in the intensive care unit, the duration of hospitalization, as well as the change in C-reactive protein level.

Results and discussion. It was found that olokizumab significantly reduces the all-cause mortality compared with standard therapy: 54 (6.21%) cases compared with 111 (12.77%) in the control arm, p<0.001, odds ratio (OR) 2.21 [1.57; 3.1]. The results of factor analysis confirmed that olokizumab increases the odds of recovery, OR 2.41 (95% CI 1.64–3.54, p<0.001). In addition, patients in olokizumab group showed significantly lower plasma CRP levels compared with control group. Already on the 2nd day after the start of therapy the CRP level was almost 2 times lower in the olokizumab group than in the control group (the median was 13 [5.6; 28.55] mg/l and 25 [15.3; 79.25] mg/L in the olokizumab and comparison groups, respectively).

Conclusion. The results of the study confirm the clinical data on the efficacy of olokizumab as therapy for COVID-19 patients.

Keywords:olokizumab; coronavirus disease 2019 (COVID-19); IL-6-inhibitors; ARDS

Funding. The study was funded by the R-Pharm Group of Companies.

Conflict of interest. The authors Mozgovaya V.G., Filon O.V., Zinkovskaya A.V., Dolgorukova A.N., Samsonov M.Yu. are employees of R-Pharm JSC. The authors Vizel A.A., Petrushin M.A., Tavlueva E.V., Markarov A.E., Ignatova G.L., Antonov V.N., Agafina A.S., Bakirov B.A. are investigators in the CL04041090 study sponsored by R-Pharm JSC.

Contribution. The concept and design of the study – Mozgovaya V.G., Filon O.V., Samsonov M.Yu., Zinkovskaya A.V.; data collection – Visel A.A., Petrushin M.A., Tavlueva E.V., Markarov A.E., Ignatova G.L., Antonov V.N., Agafina A.S., Bakirov B.A.; data analysis and statistical processing – Zinkovskaya A.V., Dolgorukova A.N.; writing the text – Mozgovaya V.G., Filon O.V.; review – Samsonov M.Yu.

For citation: Tavlueva E.V., Markarov A.E., Petrushin M.A., Wiesel A.A., Ignatova G.L., Antonov V.N., Agafina A.S., Bakirov B.A., Mozgovaya V.G., Filon O.V., Zinkovskaya A.V., Dolgorukova A.N., Samsonov M.Yu. Olokizumab reduces the risks of death in hospitalized patients with moderate and severe COVID-19. Infektsionnye bolezni: novosti, mneniya, obuchenie [Infectious Diseases: News, Opinions, Training]. 2022; 11 (4): 8–18. DOI: https://doi.org/10.33029/2305-3496-2022-11-4-8-18

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CHIEF EDITOR
Aleksandr V. Gorelov
Academician of the Russian Academy of Sciences, MD, Head of Infection Diseases and Epidemiology Department of the Scientific and Educational Institute of Clinical Medicine named after N.A. Semashko ofRussian University of Medicine, Ministry of Health of the Russian Federation, Professor of the Department of Childhood Diseases, Clinical Institute of Children's Health named after N.F. Filatov, Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation, Deputy Director for Research, Central Research Institute of Epidemiology, Rospotrebnadzor (Moscow, Russian Federation)

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