Levilimab and baricitinib prescribing experience in outpatient COVID-19 patients’ treatment

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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.

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, Moscow

Andrey V. Starshinin

Department of Health

Email: alrheumo@mail.ru
ORCID iD: 0000-0003-3565-2124

канд. мед. наук, зам. рук. ДЗМ

Russian Federation, Moscow

Yulia O. Antipova

Department of Health

Email: alrheumo@mail.ru

зам. рук. ДЗМ

Russian Federation, Moscow

Mariana 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; Moscow

Yulia V. Urozhaeva

Main Control Department

Email: alrheumo@mail.ru
ORCID iD: 0000-0002-0378-0642

зам. нач. Главного контрольного управления г. Москвы

Russian Federation, Moscow

Olga 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, Moscow

Natalya 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, Moscow

Andrei 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; Moscow

Elena 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, Moscow

Natalia V. Okolot

City Polyclinic №166

Email: alrheumo@mail.ru
ORCID iD: 0000-0001-5159-3959

глав. врач ГБУЗ ГП №166

Russian Federation, Moscow

Maria 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, Moscow

Daria 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; Moscow

Elena 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, Moscow

Tatiana 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, Moscow

Anton 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; Moscow

Alena 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; Moscow

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Supplementary files

Supplementary Files
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1. JATS XML
2. Fig. 1. Time from start of observation to hospitalization: survival curves (Kaplan–Meier method).

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3. Fig. 2. Results of monitoring clinical and laboratory parameters of C-reactive protein and lymphocytes.

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4. Fig. 3. The frequency of endpoints of the effectiveness of therapy during hospitalization of patients.

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