Efficacy of olokizumab in patients with mild or moderate COVID-19 and risk factors of progression
D. S. Fomina,
S. S. Andreev,
G. V. Andrenova,
T. S. Kruglova,
D. M. Demidchik,
O. S. Kovalevskaya,
Z. Yu. Mutovina,
E. A. Dokukina,
O. V. Filon,
A. V. Petkova,
E. K. Khanonina,
M. Yu. Samsonov https://doi.org/10.18093/0869-0189-2023-33-5-623-632
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 4th 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.
Keywords
olokizumab,
new coronavirus infection (COVID-19),
Janus kinase inhibitors,
acute respiratory distress syndrome,
interleukin-6
Supporting agencies: The study was sponsored by R-Pharm group of companies.
About the Authors
D. S. Fomina
State Budgetary Healthcare Institution of Moscow City “Moscow City Clinical Hospital 52”, Moscow Department of Health; Federal State Autonomous Educational Institution of Higher Education I.M.Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University); Non-profit Joint Stock Company “Astana Medical University”, Ministry of Health of the Republic of Kazakhstan
Russian Federation
Competing Interests:
Russian Federation
Daria S. Fomina, Candidate of Medicine, Associate Professor, Allergist-immunologist, Head of Moscow City Scientific and Practical Center of Allergology and Immunology, State Budgetary Healthcare Institution of Moscow City “Moscow City Clinical Hospital 52”, Moscow Department of Health; Associate Professor, Department of Clinical Allergology аnd Immunology, Federal State Autonomous Educational Institution of Higher Education I.M.Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University); Professor, Non-profit Joint Stock Company “Astana Medical University”, Ministry of Health of the Republic of Kazakhstan; Chief Specialist, Allergist-Immunologist, Moscow Department of Health
ul. Pekhotnaya 3, Moscow, 123182; ul. Trubetskaya 8, build. 2, Moscow, 119991; ul. Beibitshilik 49a, Nur-Sultan, 010000, Republic of Kazakhstan
tel.: (499) 196-19-54
Competing Interests:
D.S.Fomina is investigators in the study conducted according to the protocol CL04041200 and sponsored by R-Pharm Joint Stock Company.
S. S. Andreev
State Budgetary Healthcare Institution of Moscow City “Moscow City Clinical Hospital 52”, Moscow Department of Health
Russian Federation
Competing Interests:
Russian Federation
Sergey S. Andreev, Head of the Department of Clinical Pharmacology
ul. Pekhotnaya 3, Moscow, 123182
tel.: (499) 196-09-23
Competing Interests:
S.S.Andreev is investigators in the study conducted according to the protocol CL04041200 and sponsored by R-Pharm Joint Stock Company.
G. V. Andrenova
State Budgetary Healthcare Institution of Moscow City “Moscow City Clinical Hospital 52”, Moscow Department of Health
Russian Federation
Competing Interests:
Russian Federation
Gerelma V. Andrenova, Allergist-Immunologist
ul. Pekhotnaya 3, Moscow, 123182
tel.: (499) 196-29-88
Competing Interests:
G.V.Andrenova is investigators in the study conducted according to the protocol CL04041200 and sponsored by R-Pharm Joint Stock Company.
T. S. Kruglova
State Budgetary Healthcare Institution of Moscow City “Moscow City Clinical Hospital 52”, Moscow Department of Health
Russian Federation
Competing Interests:
Russian Federation
Tatiana S. Kruglova, Allergist-Immunologist, Head of the Department of Allergology and Immunology
ul. Pekhotnaya 3, Moscow, 123182
tel.: (499) 194-74-36
Competing Interests:
T.S.Kruglova is investigators in the study conducted according to the protocol CL04041200 and sponsored by R-Pharm Joint Stock Company.
D. M. Demidchik
State Budgetary Healthcare Institution of Moscow City “Moscow City Clinical Hospital 52”, Moscow Department of Health
Russian Federation
Russian Federation
Diana M. Demidchik, Allergist-Immunologist, Physician, Department of Rheumatology, Moscow City Scientific and Practical Center of Allergology and Immunology
ul. Pekhotnaya 3, Moscow, 123182
tel.: (499) 196-17-76
O. S. Kovalevskaya
State Budgetary Healthcare Institution of Moscow City “Moscow City Clinical Hospital 52”, Moscow Department of Health
Russian Federation
Competing Interests:
Russian Federation
Olga S. Kovalevskaya, Analyst of the Information and Analytical Department
ul. Pekhotnaya 3, Moscow, 123182
tel.: (499) 196-17-86
Competing Interests:
O.S.Kovalevskaya is investigators in the study conducted according to the protocol CL04041200 and sponsored by R-Pharm Joint Stock Company.
Z. Yu. Mutovina
State Budgetary Healthcare Institution of Moscow City “Moscow City Clinical Hospital 52”, Moscow Department of Health
Russian Federation
Competing Interests:
Russian Federation
Zinaida U. Mutovina, Candidate of Medicine, Rheumatologist, Head of the Rheumatology Department, Interdistrict Rheumatology Center
ul. Pekhotnaya 3, Moscow, 123182
tel.: (499) 196-17-76
Competing Interests:
Z.Yu.Mutovina is investigators in the study conducted according to the protocol CL04041200 and sponsored by R-Pharm Joint Stock Company.
E. A. Dokukina
Joint Stock Company “R-Pharm”
Russian Federation
Competing Interests:
Russian Federation
Ekaterina A. Dokukina, medical monitor
Leninskiy prospekt 111b, Moscow, 119421
tel.: (495) 956-79-37
Competing Interests:
E.A.Dokukina is employees of R-Pharm JSC.
O. V. Filon
Joint Stock Company “R-Pharm”
Russian Federation
Competing Interests:
Russian Federation
Olga V. Filon, Director, Department of Preclinical and Clinical Development
Leninskiy prospekt 111b, Moscow, 119421
tel.: (495) 956-79-37
Competing Interests:
O.V.Filon is employees of R-Pharm JSC.
A. V. Petkova
Joint Stock Company “R-Pharm”
Russian Federation
Competing Interests:
Russian Federation
Anna V. Petkova, Head of the Biostatistics Group, Department of Preclinical and Clinical Development
Leninskiy prospekt 111b, Moscow, 119421
tel.: (495) 956-79-37
Competing Interests:
A.V.Petkova is employees of R-Pharm JSC.
E. K. Khanonina
Joint Stock Company “R-Pharm”
Russian Federation
Competing Interests:
Russian Federation
Elizaveta K. Khanonina, Medical Writer
Leninskiy prospekt 111b, Moscow, 119421
tel.: (917) 554-20-48
Competing Interests:
E.K.Khanonina is employees of R-Pharm JSC.
M. Yu. Samsonov
Joint Stock Company “R-Pharm”
Russian Federation
Competing Interests:
Russian Federation
Mikhail Yu. Samsonov, Candidate of Medicine, Director of Medical Directorate
Leninskiy prospekt 111b, Moscow, 119421
tel.: (495) 956-79-37
Competing Interests:
M.Yu.Samsonov is employees of R-Pharm JSC.
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Fomina D.S., Andreev S.S., Andrenova G.V., Kruglova T.S., Demidchik D.M., Kovalevskaya O.S., Mutovina Z.Yu., Dokukina E.A., Filon O.V., Petkova A.V., Khanonina E.K., Samsonov M.Yu. Efficacy of olokizumab in patients with mild or moderate COVID-19 and risk factors of progression. PULMONOLOGIYA. 2023;33(5):623-632. (In Russ.) https://doi.org/10.18093/0869-0189-2023-33-5-623-632
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