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

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Дәйексөз келтіру

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Аннотация

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.

Негізгі сөздер

Толық мәтін

Рұқсат жабық

Авторлар туралы

Bulat Bakirov

Bashkir State Medical University, Ministry of Health of Russia

Хат алмасуға жауапты Автор.
Email: bbakirov@mail.ru
ORCID iD: 0000-0002-3297-1608

MD, Associate Professor, Head, Hospital Therapy Department Two

Ресей, Ufa

Аlina Agafyina

City Hospital Forty, Kurortnyi District

Email: a.agafina@mail.ru
ORCID iD: 0000-0003-2598-4440

Cand. Med. Sci., Head, Department for Preclnical and Clinical Trials

Ресей, Saint Petersburg

Evgenia Tavlueva

F.I. Inozemtsev City Clinical Hospital, Moscow City Healthcare Department

Email: tavlev1@mail.ru
ORCID iD: 0000-0002-6796-212X

MD, Head, Regional Vascular Center

Ресей, Moscow

Viktoria Lesina

Voronezh Regional Clinical Hospital One

Email: vita252007@yandex.ru
ORCID iD: 0000-0001-8231-6591

Pulmonologist

Ресей, Voronezh

Natalia Kostina

Voronezh Regional Clinical Hospital One

Email: nata166k@yahoo.com
ORCID iD: 0000-0002-5128-5005

Cand. Med. Sci., Head, Department of Pulmonology

Ресей, Voronezh

Galina Ignatova

Institute of Additional Professional Education, South Ural State Medical University

Email: iglign@mail.ru
ORCID iD: 0000-0002-0877-6554

MD, Professor, Head, Department of Therapy, Institute of Additional Professional Education, South Ural State Medical University; Principal Pulmonologist of the Ural Federal District

Ресей, Chelyabinsk

Оleg Ostroverkhov

Astrakhan State Medical University, Ministry of Health of Russia

Email: olostr@mail.ru

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

Ресей, Astrakhan

Valeria Rechnik

Central City Clinical Hospital

Email: tinartan@mail.ru
ORCID iD: 0000-0003-0013-8854

Head, Infectous Disease Unit Two, Central City Clinical Hospital, Principal Freelance for Infectious Diseases, Ministry of Health of the Ulyanovsk Region

Ресей, Ulyanovsk

Vadim Soldatov

Pskov Regional Infectious Diseases Clinical Hospital

Email: soldatvadim2018@gmail.com
ORCID iD: 0000-0002-6898-7572

Cand. Med. Sci., Anesthesiologist/Resuscitation Specialist

Ресей, Pskov

Irina Demko

Professor V.F. Voino-Yasenetsky Krasnoyarsk State Medical University, Ministry of Health of Russia

Email: demko64@mail.ru
ORCID iD: 0000-0001-8982-5292

MD, Professor

Ресей, Krasnoyarsk

Tatiana Mukha

Voronezh Regional Center for AIDS Prevention and Control

Email: muhauv@mail.ru
ORCID iD: 0000-0002-4615-3868

Deputy Chief Medical Officer

Ресей, Voronezh

Viktoria Bakhtina

Specialized Clinical Infectious Diseases Hospital, Ministry of Health of the Krasnodar Territory

Email: dom-167@mail.ru
ORCID iD: 0000-0001-6065-2922

Cand. Med. Sci., Deputy Head Physician

Ресей, Krasnodar

Еlena Kuncevich

Samara City Hospital Six

Email: kuncelena77@mail.ru
ORCID iD: 0000-0002-4486-907X

Head, Infectous Disease Unit

Ресей, Samara

Anna Simakova

Territorial Clinical Infectious Diseases Hospital Two

Email: anna-inf@mail.ru

MD, Associate Professor, Head, Primorsky Regional Center for Viral Hepatitis, Territorial Clinical Infectious Diseases Hospital Two; Principal Infectiologist of the Primorye Territory

Ресей, Vladivostok

Anatoly Vorobyev

Independent Researcher

Email: vorobev.a.s.math.engine@gmail.com
ORCID iD: 0000-0002-1249-3856

Biostatistician

Ресей

Valentina Mozgovaya

JSC «R-Pharm»

Email: mozgovay@rpharm.ru
ORCID iD: 0000-0002-8934-8884

Scientific Advisor

Ресей, Moscow

Olga Filon

JSC «R-Pharm»

Email: ov.filon@rpharm.ru
ORCID iD: 0000-0002-8735-7429

Director, Department

Ресей, Moscow

Anna Petkova

JSC «R-Pharm»

Email: zinkovskaya@rpharm.ru
ORCID iD: 0000-0002-7028-0496

Head, Biostatistics Group, Department of Preclinical and Clinical Developments

Ресей, Moscow

Еkaterina Dokukina

JSC «R-Pharm»

Email: kate.dokukina@gmail.com
ORCID iD: 0000-0002-6759-673X

Medical Monitoring Specialist

Ресей, Moscow

Elizaveta Khanonina

JSC «R-Pharm»

Email: khanonina@rphapm.ru
ORCID iD: 0000-0001-5848-0869

Medical Writer

Ресей, Moscow

Mikhail Samsonov

JSC «R-Pharm»

Email: samsonov@rpharm.ru
ORCID iD: 0000-0003-2685-1623

Cand. Med. Sci., Associate Professor, Medical Director

Ресей, Moscow

Vasily Ignatyev

JSC «R-Pharm»

Email: nfo@rpharm.ru
ORCID iD: 0000-0003-2818-6583

Cand. Med. Sci., Director General

Ресей, Moscow

Әдебиет тізімі

  1. Hu B., Huang S., Yin L. The cytokine storm and COVID‐19. Journal of Medical Virology 2021; 93(1): 250–6. doi: 10.1002/jmv.26232
  2. Yang L., Xie X., Tu Z., Fu J., Xu D., Zhou Y. The signal pathways and treatment of cytokine storm in COVID-19. Signal Transduction and Targeted Therapy 2021; 6(1): 255. doi: 10.1038/s41392-021-00679-0
  3. Временные методические рекомендации Минздрава России «Профилактика, диагностика и лечение коронавирусной инфекции (COVID- 19)», версия 15 от 22.02.2022. https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/059/392/original/%D0%92%D0%9C%D0%A0_COVID-19_V15.pdf [Temporary guidelines. «Prevention, diagnosis and treatment of new coronavirus infection (COVID 2019)», Version 15 by 22.02.2022]. Ministry of Health of the Russian Federation, 2020. [In Russ.]. https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/059/392/original/%D0%92%D0%9C%D0%A0_COVID-19_V15.pdf
  4. Shaw S., Bourne T., Meier .C, Carrington B., Gelinas R., Henry A. et al. Discovery and characterization of olokizumab: a humanized antibody targeting interleukin-6 and neutralizing gp130-signaling. MAbs. 2014; (6): 774–82. doi: 10.4161/mabs.28612
  5. Mahmoud A.M. Olokizumab’s effectiveness and safety in patients with rheumatoid arthritis: a systematic review and meta-analysis of randomized controlled trials. Journal of Clinical Densitometry. 2023; 26(1): 61–82. doi: 10.1016/j.jocd.2022.12.003
  6. Тавлуева Е.В., Зернова Е.В., Кутепова М.П., Костина Н.Э., Лесина В.С., Moулд Д.Р. и др. Особенности фармакокинетики олокизумаба у пациентов c новой коронавирусной инфекцией COVID-19. Фармация и фармакология 2022; 10(5): 460–71. doi: 10.19163/2307-9266-2022-10-5-460-471. Tavlueva E.V., Zernova E.V., Kutepova M.P., Kostina N.E., Lesina V.S., Mould D.R. et al. [Characteristics of olokizumab pharmacokinetics in patients with novel coronavirus infection COVID-19]. Pharmacy & Pharmacology. 2022; 10(5): 460–71. [In Russ.]. doi: 10.19163/2307-9266-2022-10-5-460-471
  7. Kretsos K., Golor G., Jullion A., Hickling M., McCabe S., Shaw S. et al. Safety and pharmacokinetics of olokizumab, an anti-IL-6 monoclonal antibody, administered to healthy male volunteers: A randomized phase I study. Clin. Pharmacol. Drug. Dev. 2014; 3(5): 388–95. doi: 10.1002/cpdd.121
  8. Fleischmann R., Kivitz A.J., Wagner F., Feinstein J.A., Fuhr U., Rech J. et al. A Pilot Study Investigating the Tolerability and Pharmacodynamic Effect of Single Intravenous/Subcutaneous Doses of Olokizumab, an Anti-Interleukin-6 Monoclonal Antibody, in Patients with Rheumatoid Arthritis. Arthritis and Rheumatism 2012; 64(10): 576–7.

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Әрекет
1. JATS XML
2. Fig. 1. The factors influencing the occurrence of events

Жүктеу (446KB)
3. Fig. 2. Changes in the Me levels of CRP (a) and lymphocytes (b) during the study period

Жүктеу (159KB)

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