The efficiency of different olokizumab dosage regimens in patients with mild and moderate coronavirus disease (COVID-19)


DOI: https://dx.doi.org/10.18565/epidem.2023.13.1.105-15

Bakirov B.A., Agafyina A.S., Tavlueva E.V., Lesina V.S., Kostina N.E., Ignatova G.L., Ostroverkhov O.P., Rechnik V.N., Soldatov V.M., Demko I.V., Mukha T.A., Bakhtina V.A., Kuncevich E.V., Simakova A.I., Vorobyev A.S., Mozgovaya V.G., Filon O.V., Petkova A.V., Dokukina E.A., Khanonina E.K., Samsonov M.Yu., Ignatyev V.G.

1) Bashkir State Medical University, Ministry of Health of Russia, Ufa, Russia; 2) City Hospital Forty, Kurortnyi District, Saint Petersburg, Russia; 3) F.I. Inozemtsev City Clinical Hospital, Moscow City Healthcare Department, Moscow, Russia; 4) Voronezh Regional Clinical Hospital One, Voronezh, Russia; 5) Institute of Additional Professional Education, South Ural State Medical University, Chelyabinsk, Russia; 6) Astrakhan State Medical University, Ministry of Health of Russia, Astrakhan, Russia; 7) Central City Clinical Hospital, Ulyanovsk, Russia; 8) Pskov Regional Infectious Diseases Clinical Hospital, Pskov, Russia; 9) Professor V.F. Voino-Yasenetsky Krasnoyarsk State Medical University, Ministry of Health of Russia, Krasnoyarsk, Russia; 10) Voronezh Regional Center for AIDS Prevention and Control, Voronezh, Russia; 11) Specialized Clinical Infectious Diseases Hospital, Ministry of Health of the Krasnodar Territory, Krasnodar, Russia; 12) Samara City Hospital Six, Samara, Russia; 13) Territorial Clinical Infectious Diseases Hospital Two, Vladivostok. Russia; Ministry of Health of the Krasnodar Territory, Krasnodar, Russia; 14) Independent Researcher; 15) JSC «R-Pharm», Moscow, Russia
Objective. To identify a patient profile and to evaluate the efficacy of different doses and routes of administration of olokizumab in patients with mild to moderate COVID-19.
Subjects and methods. The RESMICA multicenter non-interventional retrospective study was conducted. This study included patients data 1,104 patients with mild to moderate COVID-19 who received therapy with olokizumab at doses of 64 or 128 mg subcutaneously (SC) or intravenously (IV). The investigators used statistical tests and modeling adjustment for demographic characteristics, initial state of the patients, and risk factors.
Results. Olokizumab at a SC dose of 64 mg was primarily prescribed to patients with mild or moderate COVID- 19, a low level of comorbidity, and moderate signs of inflammation. That at a SC dose of 128 mg was given to patients with a similar profile, but a significantly higher level of comorbidity. The drug at IV doses of 64 or 128 mg was prescribed mainly to patients with moderate COVID-19 and more pronounced signs of the disease.
Conclusion. The use of olokizumab at a dose of 128 mg reduces the risk of an adverse COVID-19 outcome.
Keywords: IL-6 inhibitor, olokizumab, cytokine storm, COVID-19
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About the Autors

Bulat A. Bakirov, MD, Associate Professor, Head, Hospital Therapy Department Two, Bashkir State Medical University, Ministry of Health of Russia, Ufa, Russia; bbakirov@mail.ru; http://orcid.org/0000-0002-3297-1608
Аlina S. Agafyina, Cand. Med. Sci., Head, Department for Preclnical and Clinical Trials, City Hospital Forty, Saint Petersburg, Russia; a.agafina@mail.ru; http://orcid.org/0000-0003-2598-4440
Evgenia V. Tavlueva, MD, Head, Regional Vascular Center, F.I. Inozemtsev City Clinical Hospital, Moscow City Healthcare Department, Moscow, Russia; tavlev1@mail.ru; http://orcid.org/0000-0002-6796-212X
Viktoria S. Lesina, Pulmonologist, Voronezh Regional Clinical Hospital One, Voronezh, Russia; vita252007@yandex.ru; http://orcid.org/0000-0001-8231-6591
Natalia E. Kostina, Cand. Med. Sci., Head, Department of Pulmonology, Voronezh Regional Clinical Hospital One;, Principal Pulmonologist, Healthcare Department of the Voronezh Region, Voronezh, Russia; nata166k@yahoo.com; http://orcid.org/0000-0002-5128-5005
Professor Galina L. Ignatova, MD, Head, Department of Therapy, Institute of Additional Professional Education, South Ural State Medical University; Principal Pulmonologist of the Ural Federal District, Chelyabinsk, Russia; iglign@mail.ru; http://orcid.org/0000-0002-0877-6554; 454021
Оleg P. Ostroverkhov, Cand. Med. Sci., Associate Professor, Department of Clinical Pharmacology, Astrakhan State Medical University, Ministry of Health of Russia; Principal Specialist, Clinical Pharmacologist, Ministry of Health of the Astrakhan Region, Astrakhan, Russia; olostr@mail.ru; http://orcid.org/0000-0002-5128-5005
Valeria N. Rechnik, Head, Infectous Disease Unit Two, Central City Clinical Hospital, Principal Freelance For Infectious Diseases, Ministry of Health of the Ulyanovsk Region, Ulyanovsk, Russia; tinartan@mail.ru; http://orcid.org/0000-0003-0013-8854
Vadim M. Soldatov, Cand. Med. Sci., Anesthesiologist/Resuscitation Specialist, Pskov Regional Infectious Diseases Clinical Hospital, Pskov, Russia; soldatvadim2018@gmail.com; http://orcid.org/0000-0002-6898-7572
Professor Irina V. Demko, MD, Professor V.F. Voino-Yasenetsky Krasnoyarsk State Medical University, Ministry of Health of Russia, Krasnoyarsk, Russia; demko64@mail.ru; http://orcid.org/0000-0001-8982-5292
Tatiana A. Mukha, Deputy Chief Medical Officer, Voronezh Regional Center for AIDS Prevention and Control, Voronezh, Russia; muhauv@mail.ru, http://orcid.org/0000-0002-4615-3868
Viktoria A. Bakhtina, Cand. Med. Sci., Deputy Head Physician, Specialized Clinical Infectious Diseases Hospital, Ministry of Health of the Krasnodar Territory, Krasnodar, Russia; dom-167@mail.ru; http://orcid.org/0000-0001-6065-2922
Еlena V. Kuncevich, Head, Infectous Disease Unit, Samara City Hospital Six, Samara, Russia; kuncelena77@mail.ru; http://orcid.org/0000-0002-4486-907Х-443068
Anna I. Simakova, MD, Associate Professor, Head, Primorsky Regional Center for Viral Hepatitis, Territorial Clinical Infectious Diseases Hospital Two; Principal Infectiologist of the Primorye Territory, Vladivostok. Russia; anna-inf@mail.ru; http://orcid.org/0000-0003-3465-8372
Anatoly S. Vorobyev, Biostatistician, Independent Researcher; vorobev.a.s.math.engine@gmail.com; http://orcid.org/ 0000-0002-1249-3856.
Valentina G. Mozgovaya, Scientific Advisor, JSC «R-Pharm». Moscow, Russia; mozgovay@rpharm.ru; http://orcid.org/ 0000-0002-8934-8884
Olga V. Filon, Director, Department, JSC «R-Pharm», Moscow, Russia; ov.filon@rpharm.ru; http://orcid.org/ 0000-0002-8735-7429.
Anna V. Petkova, Head, Biostatistics Group, Department of Preclinical and Clinical Developments, JSC «R-Pharm», Moscow, Russia; zinkovskaya@rpharm.ru; http://orcid.org/ 0000-0002-7028-0496
Еkaterina А. Dokukina, Medical Monitoring Specialist, JSC «R-Pharm», Moscow, Russia; kate.dokukina@gmail.com, https://orcid.org/0000-0002-6759-673X
Elizaveta K. Khanonina, Medical Writer, JSC «R-Pharm», Moscow, Russia; khanonina@rphapm.ru; http://orcid.org/0000-0001-5848-0869
Mikhail Yu. Samsonov, Cand. Med. Sci., Associate Professor, Medical Director, JSC «R-Pharm», Moscow, Russia; samsonov@rpharm.ru; http://orcid.org/0000-0003-2685-1623
Vasily G. Ignatyev, Cand. Med. Sci., Director General, JSC «R-Pharm», Moscow, Russia; nfo@rpharm.ru; http://orcid.org/0000-0003-2818-6583


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