Terapevticheskii arkhivTerapevticheskii arkhiv0040-36602309-5342LLC Obyedinennaya Redaktsiya11185010.26442/00403660.2022.08.201788UnknownExperience of anticipatory therapy with IL-6 receptor inhibitors and perspectives for its use in the evolution of COVID-19ChulanovVladimir P.gvl3@yandex.ruhttps://orcid.org/0000-0001-6303-9293BakirovBulat A.gvl3@yandex.ruhttps://orcid.org/0000-0002-3297-1608VezikovaNatalia N.gvl3@yandex.ruhttps://orcid.org/0000-0002-8901-3363GorodinVladimir N.gvl3@yandex.ruhttps://orcid.org/0000-0003-3062-7595ZhuravlevaMarina V.gvl3@yandex.ruhttps://orcid.org/0000-0002-9198-8661ZagrebnevaAlena I.gvl3@yandex.ruhttps://orcid.org/0000-0002-3235-1425IvanovIgor G.gvl3@yandex.ruhttps://orcid.org/0000-0003-3040-4009LomakinNikita V.gvl3@yandex.ruhttps://orcid.org/0000-0001-8830-7231LukinaGalina V.gvl3@yandex.ruhttps://orcid.org/0000-0001-7958-5926MoysovaDiana L.gvl3@yandex.ruhttps://orcid.org/0000-0003-3920-5997MutovinaZinaida I.gvl3@yandex.ruhttps://orcid.org/0000-0001-5809-6015National Medical Research Center for Phthisiopulmonology and Infectious DiseasesBashkir State Medical UniversityPetrozavodsk State UniversityKuban State Medical UniversityScientific Centre for Expert Evaluation of Medicinal ProductsCity Clinical Hospital No. 52Pirogov Russian National Research Medical UniversityCity Hospital of St. George the Great MartyrSaint Petersburg State UniversityCentral Clinical Hospital with a Polyclinic of the Administrative Department of the President of the Russian FederationCentral State Medical Academy of the Administrative Department of the President of the Russian FederationLoginov Moscow Clinical Scientific CenterNasonova Research Institute of Rheumatology12102022948102810351210202212102022Copyright © 2022, Consilium Medicum2022<p><strong>The Advisory Board chaired by the chief specialist in infectious diseases of the Ministry of Health of Russian Federation, Professor V.P. Chulanov was held on June 18, 2022 in Saint Petersburg.</strong></p>
<p><strong>Aim</strong>. The main purpose of the Board was following discussion:</p>
<ol>
<li>the analysis of the real-world data of levilimab as an anticipatory therapy for COVID-19 in hospitalized patients;</li>
<li>the review of the experience and perspectives of levilimab as an anticipatory anti-inflammatory option for outpatient patients who meet defined clinical and laboratory criteria.</li>
</ol>
<p><strong>Results</strong>. The analyzed data on clinical efficacy and safety formed the basis of recommendations proposed by experts for the use of levilimab in the inpatient and outpatient medical care for COVID-19.</p>COVID-19anti-inflammatory therapyinterleukin-6 receptor inhibitionlevilimabCOVID-19противовоспалительная терапияингибиция рецептора интерлейкина-6левилимаб[Sun X, Wang T, Cai D, et al. Cytokine storm intervention in the early stages of COVID-19 pneumonia. Cytokine Growth Factor Rev. 2020;53:38-42. DOI:10.1016/j.cytogfr.2020.04.002][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][Scheller J, Chalaris A, Schmidt-Arras D, Rose-John S. The pro- and anti-inflammatory properties of the cytokine interleukin-6. Biochim Biophys Acta. 2011;1813(5):878-88. DOI:10.1016/j.bbamcr.2011.01.034][Arulkumaran N, Snow TAC, Kulkarni A, et al. Influence of IL-6 levels on patient survival in COVID-19. J Crit Care. 2021;66:123-5. DOI:10.1016/j.jcrc.2021.08.013][Copaescu A, Smibert O, Gibson A, et al. The role of IL-6 and other mediators in the cytokine storm associated with SARS-CoV-2 infection. J Allergy Clin Immunol. 2020;146(3):518-34.e1. DOI:10.1016/j.jaci.2020.07.001][Avni T, Leibovici L, Cohen I, et al. Tocilizumab in the treatment of COVID-19-a meta-analysis. QJM. 2021;114(8):577-86. DOI:10.1093/qjmed/hcab142][Pinzon RT, Wijaya VO, Buana RB. Interleukin-6 (IL-6) inhibitors as therapeutic agents for coronavirus disease 2019 (COVID-19): A systematic review and meta-analysis. J Infect Public Health. 2021;14(8):1001-9. DOI:10.1016/j.jiph.2021.06.004][WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group, Shankar-Hari M, Vale CL, et al. Association Between Administration of IL-6 Antagonists and Mortality Among Patients Hospitalized for COVID-19: A Meta-analysis. JAMA. 2021;326(6):499-518. DOI:10.1001/jama.2021.11330][Kyriakopoulos C, Ntritsos G, Gogali A, et al. Tocilizumab administration for the treatment of hospitalized patients with COVID-19: A systematic review and meta-analysis. Respirology. 2021;26(11):1027-40. DOI:10.1111/resp.14152][Vela D, Vela-Gaxha Z, Rexhepi M, et al. Efficacy and safety of tocilizumab versus standard care/placebo in patients with COVID-19; a systematic review and meta-analysis of randomized clinical trials. Br J Clin Pharmacol. 2022;88(5):1955-63. DOI:10.1111/bcp.15124][Rubio-Rivas M, Forero CG, Mora-Luján JM, et al. Beneficial and harmful outcomes of tocilizumab in severe COVID-19: A systematic review and meta-analysis. Pharmacotherapy. 2021;41(11):884-906. DOI:10.1002/phar.2627][Насонов Е.Л., Мазуров В.И., Усачева Ю.В., и др. Разработки отечественных оригинальных генно-инженерных биологических препаратов для лечения иммуновоспалительных ревматических заболеваний. Научно-практическая ревматология. 2017;55(2):201-10 [Nasonov EL, Mazurov VI, Usacheva YuV, et al. Developments of Russian original biological agents for the treatment of immunoinflammatory rheumatic diseases. Rheumatology Science and Practice. 2017;55(2):201-10 (in Russian)]. DOI:10.14412/1995-4484-2017-201-210][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][Рекомендации для врачей по COVID-19. Профилактика, диагностика и лечение новой коронавирусной инфекции COVID-19. Режим доступа: https://minzdrav.gov.ru/ministry/med_covid19. Ссылка активна на 03.08.2022 [Rekomendatsii dlia vrachei po COVID-19. Profilaktika, diagnostika i lechenie novoi koronavirusnoi infektsii COVID-19. Available at: https://minzdrav.gov.ru/ministry/med_covid19. Accessed: 03.08.2022 (in Russian)].][Тавлуева Е.В., Иванов И.Г., Лыткина К.А., и др. Применение левилимаба у пациентов с новой коронавирусной инфекцией (COVID-19) в реальной клинической практике. Клиническая фармакология и терапия. 2021;30(3):7-13 [Tavlueva EV, Ivanov IG, Lytkina KA, et al. Levilimab in patients with COVID-19 in real-life practice. Clinical Pharmacology and Therapy. 2021;30(3):7-13 (in Russian)]. DOI:10.32756/0869-5490-2021-3-31-37][Городин В.Н., Мойсова Д.Л., Зотов С.В., и др. Особенности упреждающей противовоспалительной терапии левилимабом при COVID-19. Инфекционные болезни. 2021;19(3):14-23 [Gorodin VN, Moisova DL, Zotov SV, et al. Proactive anti-inflammatory therapy with levilimab for patients with COVID-19. Infectious diseases. 2021;19(3):14-23 (in Russian)]. DOI:10.20953/1729-9225-2021-3-14-23][Wang Y, Chen R, Hu F, et al. Transmission, viral kinetics and clinical characteristics of the emergent SARS-CoV-2 Delta VOC in Guangzhou, China. EClinicalMedicine. 2021;40:101129. DOI:10.1016/j.eclinm.2021.101129][Письмо Минздрава России от 15 апреля 2022 г. №17-6/И/2-6047 «О направлении методических рекомендаций ”Организация оказания медицинской помощи пациентам с симптомами ОРВИ, гриппа, новой коронавирусной инфекции (COVID-19) и подозрением на нее в амбулаторных условиях, в том числе на дому, взрослому населению”». Режим доступа: https://base.garant.ru/404708319/. Ссылка активна на 03.08.2022 [Pis'mo Minzdrava Rossii ot 15 aprelia 2022 g. No. 17-6/I/2-6047 «O napravlenii metodicheskikh rekomendatsii ”Organizatsiia okazaniia meditsinskoi pomoshchi patsientam s simptomami ORVI, grippa, novoi koronavirusnoi infektsii (COVID-19) i podozreniem na nee v ambulatornykh usloviiakh, v tom chisle na domu, vzroslomu naseleniiu”». Available at: https://base.garant.ru/404708319/. Accessed: 03.08.2022 (in Russian)].][Хрипун А.И., Старшинин А.В., Антипова Ю.О., и др. Опыт применения левилимаба и барицитиниба в терапии COVID-19 легкого течения на амбулаторном этапе. Терапевтический архив. 2022;94(5):668-74 [Khripun AI, Starshinin AV, Antipova YO, et al. Levilimab and baricitinib prescribing experience in outpatient COVID-19 patients’ treatment. Terapevticheskii arkhiv (Ter. Arkh.). 2022;94(5):668-74 (in Russian)]. DOI:10.26442/00403660.2022.05.201676][21-й Всероссийский конгресс – Всероссийская научно-практическая конференция с международным участием «Скорая медицинская помощь – 2022». Режим доступа: https://www.medum.org/events/smp-2022.html. Ссылка активна на 03.08.2022 [21-i Vserossiiskii kongress – Vserossiiskaia nauchno-prakticheskaia konferentsiia s mezhdunarodnym uchastiem «Skoraia meditsinskaia pomoshch' – 2022». Available at: https://www.medum.org/events/smp-2022.html. Accessed: 03.08.2022 (in Russian)].]