Levilimab and baricitinib prescribing experience in outpatient COVID-19 patients’ treatment
- Authors: Khripun A.I.1, Starshinin A.V.1, Antipova Y.O.1, Lysenko M.A.2,3, Urozhaeva Y.V.4, Gavrilenko O.F.5, Rusantsova N.A.5, Tyazhelnikov A.A.1,6, Tikhonovskaya E.Y.7, Okolot N.V.8, Sokolova M.V.9, Fomina D.S.2,10, Simonova E.N.2, Kruglova T.S.2, Chernov A.A.2,11, Zagrebneva A.I.2,3
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Affiliations:
- Department of Health
- City Clinical Hospital №52
- Pirogov Russian National Research Medical University
- Main Control Department
- Medical Inspection Center
- Consultative and Diagnostic Polyclinic №121
- City Polyclinic №36
- City Polyclinic №166
- City Polyclinic №191
- Sechenov First Moscow State Medical University (Sechenov University)
- Russian Medical Academy of Continuous Professional Education
- Issue: Vol 94, No 5 (2022)
- Pages: 668-674
- Section: Original articles
- URL: https://journals.rcsi.science/0040-3660/article/view/108789
- DOI: https://doi.org/10.26442/00403660.2022.05.201676
- ID: 108789
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Abstract
Aim. To study the effect of levilimab or baricitinib in combination with standard therapy (ST) on the incidence of severe viral pneumonia associated with a new coronavirus infection COVID-19.
Materials and methods. A multicenter, open-label observational study of the efficacy and safety of levilimab in combination with ST (group 1, n=100), baricitinib in combination with ST (group 2, n=139), or in comparison with ST (group 3, n=200) in outpatients with verified CT-1 pneumonia.
Results. According to the results of laboratory tests, patients treated with levilimab in combination with ST had the best dynamics of changes in CRP from reliably the highest level (mg/L) to the lowest in comparison with other groups. In the group of patients with ST, in contrast to the other groups, no dynamics of CRP was observed by day 5 of therapy. In group of hospitalized patients initially receiving levilimab in addition to ST, the rate of transfer to the intensive care unit (2 patients, 9.52%) and length of stay (4 days) was significantly lower compared to the values in patients in both the baricitinib group in combination with ST (7 patients, 15.56%; 5 days [interquartile range 3–6.5]) and in patients receiving ST alone (7 patients, 15.56%; 5 days [interquartile range 3–6.5]). Also in hospitalized patients we observed no statistically significant intergroup differences in the incidence of infectious complications and thromboembolic events, which confirms the safety of including levilimab or baricitinib in COVID-19 pathogenetic therapy regimens. Observational results support the hypothesis that the initial inclusion of levilimab or baricitinib in addition to ST is accompanied by a reduced risk of viral pneumonia progression.
Conclusion. The addition of levilimab or baricitinib to the therapy regimen for coronavirus infection during the outpatient phase has demonstrated a preemptive anti-inflammatory effect and reduced the probability of lung tissue damage progression.
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##article.viewOnOriginalSite##About the authors
Alexey I. Khripun
Department of Health
Email: alrheumo@mail.ru
ORCID iD: 0000-0002-2929-1142
д-р мед. наук, проф., министр правительства Москвы, рук. ДЗМ
Russian Federation, MoscowAndrey V. Starshinin
Department of Health
Email: alrheumo@mail.ru
ORCID iD: 0000-0003-3565-2124
канд. мед. наук, зам. рук. ДЗМ
Russian Federation, MoscowYulia O. Antipova
Department of Health
Email: alrheumo@mail.ru
зам. рук. ДЗМ
Russian Federation, MoscowMariana A. Lysenko
City Clinical Hospital №52; Pirogov Russian National Research Medical University
Email: alrheumo@mail.ru
ORCID iD: 0000-0001-6010-7975
д-р мед. наук, глав. врач ГБУЗ ГКБ №52, проф. каф. общей терапии фак-та дополнительного профессионального образования ФГАОУ ВО «РНИМУ им. Н.И. Пирогова»
Russian Federation, Moscow; MoscowYulia V. Urozhaeva
Main Control Department
Email: alrheumo@mail.ru
ORCID iD: 0000-0002-0378-0642
зам. нач. Главного контрольного управления г. Москвы
Russian Federation, MoscowOlga F. Gavrilenko
Medical Inspection Center
Email: alrheumo@mail.ru
ORCID iD: 0000-0003-1765-9373
зам. дир. по контролю за текущей деятельностью и работе с обращениями граждан ГКУЗ ЦМИ
Russian Federation, MoscowNatalya A. Rusantsova
Medical Inspection Center
Email: alrheumo@mail.ru
ORCID iD: 0000-0002-4947-0308
зав. организационно-методическим отд. обеспечения ведомственного контроля качества и безопасности медицинской деятельности ГКУЗ ЦМИ
Russian Federation, MoscowAndrei A. Tyazhelnikov
Department of Health; Consultative and Diagnostic Polyclinic №121
Email: alrheumo@mail.ru
ORCID iD: 0000-0002-2191-0623
канд. мед. наук, глав. внештат. специалист по первичной медико-санитарной помощи взрослому населению ДЗМ, глав. врач ГБУЗ КДП №121
Russian Federation, Moscow; MoscowElena Yu. Tikhonovskaya
City Polyclinic №36
Email: alrheumo@mail.ru
ORCID iD: 0000-0002-1295-5096
канд. мед. наук, глав. врач ГБУЗ ГП №36
Russian Federation, MoscowNatalia V. Okolot
City Polyclinic №166
Email: alrheumo@mail.ru
ORCID iD: 0000-0001-5159-3959
глав. врач ГБУЗ ГП №166
Russian Federation, MoscowMaria V. Sokolova
City Polyclinic №191
Email: alrheumo@mail.ru
ORCID iD: 0000-0001-9495-0071
канд. мед. наук, глав. врач ГБУЗ ГП №191
Russian Federation, MoscowDaria S. Fomina
City Clinical Hospital №52; Sechenov First Moscow State Medical University (Sechenov University)
Email: alrheumo@mail.ru
ORCID iD: 0000-0002-5083-6637
канд. мед. доц., наук, врач аллерголог-иммунолог, рук. Московского городского научно-практического центра аллергологии и иммунологии ГБУЗ ГКБ №52, доц. каф. клинической иммунологии и аллергологии ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова» (Сеченовский Университет)
Russian Federation, Moscow; MoscowElena N. Simonova
City Clinical Hospital №52
Email: alrheumo@mail.ru
ORCID iD: 0000-0002-8372-6995
врач-ревматолог консультативно-диагностического отд. №2 ГБУЗ ГКБ №52
Russian Federation, MoscowTatiana S. Kruglova
City Clinical Hospital №52
Email: alrheumo@mail.ru
ORCID iD: 0000-0002-4949-9178
врач аллерголог-иммунолог, зав. отд-нием аллергологии и иммунологии ГБУЗ ГКБ №52
Russian Federation, MoscowAnton A. Chernov
City Clinical Hospital №52; Russian Medical Academy of Continuous Professional Education
Email: alrheumo@mail.ru
ORCID iD: 0000-0001-6209-387X
врач-терапевт отд. клинической фармакологии ГБУЗ ГКБ №52, мл. науч. сотр. Научно-исследовательского института молекулярной и персонализированной медицины ФГБОУ ДПО РМАНПО
Russian Federation, Moscow; MoscowAlena I. Zagrebneva
City Clinical Hospital №52; Pirogov Russian National Research Medical University
Author for correspondence.
Email: alrheumo@mail.ru
ORCID iD: 0000-0002-3235-1425
канд. мед. наук, зав. консультативно-диагностическим отд-нием №2 ГБУЗ ГКБ №52, доц. каф. общей терапии фак-та дополнительного профессионального образования ФГАОУ ВО «РНИМУ им. Н.И. Пирогова»
Russian Federation, Moscow; MoscowReferences
- Временные методические рекомендации «Профилактика, диагностика и лечение новой коронавирусной инфекции (COVID-19)». Режим доступа: https://minzdrav.gov.ru/ministry/med_covid19/ Ссылка активна на 21.04.2022 [Interim guidelines "Prevention, diagnosis and treatment of a new coronavirus infection ( COVID -19)". Available at: https://minzdrav.gov.ru/ministry/med_covid19/ Accessed: 04.21.2022 (in Russian)].
- Kronbichler A, Effenberger M, Eisenhut M, et al. Seven recommendations to rescue the patients and reduce the mortality from COVID-19 infection: An immunological point of view. Autoimmun Rev. 2020;19(7):102570. doi: 10.1016/j.autrev.2020.102570
- Brown MJ, Alazawi W, Kanoni S. Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19. N Engl J Med. 2021;385(12):1147. doi: 10.1056/NEJMc2108482
- Lomakin NV, Bakirov BA, Protsenko DN, et al. The efficacy and safety of levilimab in severely ill COVID-19 patients not requiring mechanical ventilation: results of a multicenter randomized double-blind placebo-controlled phase III CORONA clinical study. Inflamm Res. 2021;70(10-12):1233-46. doi: 10.1007/s00011-021-01507-5
- Marconi VC, Ramanan AV, de Bono S, et al. Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial. Lancet Respir Med. 2021;9(12):1407-18. doi: 10.1016/S2213-2600(21)00331-3
- Maslennikov R, Ivashkin V, Vasilieva E, et al. Tofacitinib reduces mortality in coronavirus disease 2019 Tofacitinib in COVID-19. Pulm Pharmacol Ther. 2021;69:102039. doi: 10.1016/j.pupt.2021.102039
- Melikhov O, Kruglova T, Lytkina K, et al. Use of Janus kinase inhibitors in COVID-19: a prospective observational series in 522 individuals. Ann Rheum Dis. 2021;80(9):1245-6. doi: 10.1136/annrheumdis-2021-220049
- Olivera PA, Lasa JS, Bonovas S, et al. Safety of Janus Kinase Inhibitors in Patients With Inflammatory Bowel Diseases or Other Immune-mediated Diseases: A Systematic Review and Meta-Analysis. Gastroenterology. 2020;158(6):1554-73.e12. doi: 10.1053/j.gastro.2020.01.001
- Schett G, Sticherling M, Neurath MF. COVID-19: risk for cytokine targeting in chronic inflammatory diseases? Nat Rev Immunol. 2020;20(5):271-2. doi: 10.1038/s41577-020-0312-7
- Stebbing J, Krishnan V, de Bono S, et al. Mechanism of baricitinib supports artificial intelligence-predicted testing in COVID-19 patients. EMBO Mol Med. 2020;12(8):e12697. doi: 10.15252/emmm.202012697
- Zhou Z, Price CC. Overview on the use of IL-6 agents in the treatment of patients with cytokine release syndrome (CRS) and pneumonitis related to COVID-19 disease. Expert Opin Investig Drugs. 2020;29(12):1407-12. doi: 10.1080/13543784.2020.1840549
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