The efficacy of different olokizumab dosage regimens in patients with mild and moderate coronavirus disease (COVID-19)
- Autores: Bakirov B.A.1, Agafyina А.S.2, Tavlueva E.V.3, Lesina V.S.4, Kostina N.E.4, Ignatova G.L.5, Ostroverkhov О.P.6, Rechnik V.N.7, Soldatov V.M.8, Demko I.V.9, Mukha T.A.10, Bakhtina V.A.11, Kuncevich Е.V.12, Simakova A.I.13, Vorobyev A.S.14, Mozgovaya V.G.15, Filon O.V.15, Petkova A.V.15, Dokukina Е.А.15, Khanonina E.K.15, Samsonov M.Y.15, Ignatyev V.G.15
-
Afiliações:
- Bashkir State Medical University, Ministry of Health of Russia
- City Hospital Forty, Kurortnyi District
- F.I. Inozemtsev City Clinical Hospital, Moscow City Healthcare Department
- Voronezh Regional Clinical Hospital One
- Institute of Additional Professional Education, South Ural State Medical University
- Astrakhan State Medical University, Ministry of Health of Russia
- Central City Clinical Hospital
- Pskov Regional Infectious Diseases Clinical Hospital
- Professor V.F. Voino-Yasenetsky Krasnoyarsk State Medical University, Ministry of Health of Russia
- Voronezh Regional Center for AIDS Prevention and Control
- Specialized Clinical Infectious Diseases Hospital, Ministry of Health of the Krasnodar Territory
- Samara City Hospital Six
- Territorial Clinical Infectious Diseases Hospital Two
- Independent Researcher
- JSC «R-Pharm»
- Edição: Volume 13, Nº 1 (2023)
- Páginas: 105-115
- Seção: Exchange of Experience
- URL: https://journals.eco-vector.com/2226-6976/article/view/321950
- DOI: https://doi.org/10.18565/epidem.2023.13.1.105–15
- ID: 321950
Citar
Texto integral
Acesso aberto
Acesso está concedido
Acesso é pago ou somente para assinantes
Resumo
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.
Palavras-chave
Texto integral
Sobre autores
Bulat Bakirov
Bashkir State Medical University, Ministry of Health of Russia
Autor responsável pela correspondência
Email: bbakirov@mail.ru
ORCID ID: 0000-0002-3297-1608
MD, Associate Professor, Head, Hospital Therapy Department Two
Rússia, UfaАlina 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
Rússia, Saint PetersburgEvgenia 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
Rússia, MoscowViktoria Lesina
Voronezh Regional Clinical Hospital One
Email: vita252007@yandex.ru
ORCID ID: 0000-0001-8231-6591
Pulmonologist
Rússia, VoronezhNatalia Kostina
Voronezh Regional Clinical Hospital One
Email: nata166k@yahoo.com
ORCID ID: 0000-0002-5128-5005
Cand. Med. Sci., Head, Department of Pulmonology
Rússia, VoronezhGalina 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
Rússia, ChelyabinskОleg 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
Rússia, AstrakhanValeria 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
Rússia, UlyanovskVadim Soldatov
Pskov Regional Infectious Diseases Clinical Hospital
Email: soldatvadim2018@gmail.com
ORCID ID: 0000-0002-6898-7572
Cand. Med. Sci., Anesthesiologist/Resuscitation Specialist
Rússia, PskovIrina 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
Rússia, KrasnoyarskTatiana Mukha
Voronezh Regional Center for AIDS Prevention and Control
Email: muhauv@mail.ru
ORCID ID: 0000-0002-4615-3868
Deputy Chief Medical Officer
Rússia, VoronezhViktoria 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
Rússia, KrasnodarЕlena Kuncevich
Samara City Hospital Six
Email: kuncelena77@mail.ru
ORCID ID: 0000-0002-4486-907X
Head, Infectous Disease Unit
Rússia, SamaraAnna 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
Rússia, VladivostokAnatoly Vorobyev
Independent Researcher
Email: vorobev.a.s.math.engine@gmail.com
ORCID ID: 0000-0002-1249-3856
Biostatistician
RússiaValentina Mozgovaya
JSC «R-Pharm»
Email: mozgovay@rpharm.ru
ORCID ID: 0000-0002-8934-8884
Scientific Advisor
Rússia, MoscowOlga Filon
JSC «R-Pharm»
Email: ov.filon@rpharm.ru
ORCID ID: 0000-0002-8735-7429
Director, Department
Rússia, MoscowAnna Petkova
JSC «R-Pharm»
Email: zinkovskaya@rpharm.ru
ORCID ID: 0000-0002-7028-0496
Head, Biostatistics Group, Department of Preclinical and Clinical Developments
Rússia, MoscowЕkaterina Dokukina
JSC «R-Pharm»
Email: kate.dokukina@gmail.com
ORCID ID: 0000-0002-6759-673X
Medical Monitoring Specialist
Rússia, MoscowElizaveta Khanonina
JSC «R-Pharm»
Email: khanonina@rphapm.ru
ORCID ID: 0000-0001-5848-0869
Medical Writer
Rússia, MoscowMikhail Samsonov
JSC «R-Pharm»
Email: samsonov@rpharm.ru
ORCID ID: 0000-0003-2685-1623
Cand. Med. Sci., Associate Professor, Medical Director
Rússia, MoscowVasily Ignatyev
JSC «R-Pharm»
Email: nfo@rpharm.ru
ORCID ID: 0000-0003-2818-6583
Cand. Med. Sci., Director General
Rússia, MoscowBibliografia
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
Arquivos suplementares
