rspНаучно-практическая ревматологияRheumatology Science and Practice1995-44841995-4492IMA-PRESS, LLC10.47360/1995-4484-2023-158-164rsp-3318Research ArticleПРОБЛЕМЫ РЕВМАТОЛОГИИ В ПЕРИОД ПАНДЕМИИ КОРОНОВИРУСНОЙ БОЛЕЗНИ 2019PROBLEMS OF RHEUMATOLOGY DURING THE 2019 CORONAVIRUS PANDEMICОпыт применения тиксагевимаба и цилгавимаба (Эвушелд) у 86 ревматологических пациентов, получающих анти-В-клеточную терапию ритуксимабомExperience with Tixagevimab and Cilgavimab (Evusheld) in 86 rheumatic patients undergoing anti-B cell therapy with rituximabhttps://orcid.org/0000-0003-2641-9785БекетоваТ. В.BeketovaT. V.

121356, Москва, ул. Маршала Тимошенко, 15; 115522, Москва, Каширское шоссе, 34а;107023, Москва, ул. Большая Семёновская, 38 

121359, Moscow, Marshala Timoshenko str., 19, building 1A; 115522, Moscow, Kashirskoye Highway, 34A; 107023, Moscow, Bolshaya Semyonovskaya str., 38

https://orcid.org/0000-0003-4546-9817ЛевинаН. О.LevinaN. О.

121356, Москва, ул. Маршала Тимошенко, 15 

121359, Moscow, Marshala Timoshenko str., 19, building 1A

https://orcid.org/0009-0007-8192-537XДубинскаяМ. В.DubinskaiaM. V.

121356, Москва, ул. Маршала Тимошенко, 15 

121359, Moscow, Marshala Timoshenko str., 19, building 1A

https://orcid.org/0009-0002-1022-4297УсковаЮ. А.UskovaYu. A.

121356, Москва, ул. Маршала Тимошенко, 15 

121359, Moscow, Marshala Timoshenko str., 19, building 1A

https://orcid.org/0000-0003-2477-7343РозановаИ. В.RozanovaI. V.

121356, Москва, ул. Маршала Тимошенко, 15 

121359, Moscow, Marshala Timoshenko str., 19, building 1A

https://orcid.org/0000-0001-8020-2494БабакВ. В.BabakV. V.

115522, Москва, Каширское шоссе, 34а 

115522, Moscow, Kashirskoye Highway, 34A

https://orcid.org/0000-0001-5562-0969БекетоваМ. Ф.BeketovaM. F.

119991, Москва, Ленинские горы, 1

119991, Moscow, Leninskie Gory, 1

https://orcid.org/0000-0001-6175-1076КрасноваТ. Н.KrasnovaT. N.

119991, Москва, Ленинские горы, 1

119991, Moscow, Leninskie Gory, 1

ФГБУ «Центральная клиническая больница с поликлиникой» Управления делами Президента Российской Федерации; ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой»; ФГАОУ ВО «Московский политехнический университет»РоссияCentral State Medical Academy of the Administrative Directorate of the President of the Russian Federation; V.A. Nasonova Research Institute of Rheumatology; Moscow Polytechnic UniversityRussian FederationФГБУ «Центральная клиническая больница с поликлиникой» Управления делами Президента Российской ФедерацииРоссияCentral State Medical Academy of the Administrative Directorate of the President of the Russian FederationRussian FederationФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой»РоссияV.A. Nasonova Research Institute of RheumatologyRussian FederationФГБОУ ВО «Московский государственный университет имени М.В. Ломоносова»РоссияLomonosov Moscow State UniversityRussian Federation202328042023612158164Copyright © Бекетова Т.В., Левина Н.О., Дубинская М.В., Ускова Ю.А., Розанова И.В., Бабак В.В., Бекетова М.Ф., Краснова Т.Н., 20232023Бекетова Т.В., Левина Н.О., Дубинская М.В., Ускова Ю.А., Розанова И.В., Бабак В.В., Бекетова М.Ф., Краснова Т.Н.Beketova T.V., Levina N.О., Dubinskaia M.V., Uskova Y.A., Rozanova I.V., Babak V.V., Beketova M.F., Krasnova T.N.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://rsp.mediar-press.net/rsp/article/view/3318

Проблема профилактики коронавирусной болезни 2019 (COVID-19, coronavirus disease 2019) у пациентов с иммуновоспалительными ревматическими заболеваниями (ИВРЗ) по-прежнему сохраняет высокую актуальность, что связано с высоким риском заболевания и тяжелого течения COVID-19, а также с низким уровнем поствакцинального ответа на фоне иммуносупрессивного лечения, прежде всего анти-В-клеточной терапии ритуксимабом (РТМ). Новой стратегией профилактики и лечения вирусных инфекций, включая COVID-19, являются вируснейтрализующие моноклональные антитела; в настоящее время в мире и РФ для профилактики зарегистрированы комбинированные моноклональные антитела длительного действия тиксагевимаб и цилгавимаб (Эвушелд) с нейтрализующей активностью против SARS-CoV-2, включая штамм Омикрон, в первую очередь его вариантов ВА.4, ВА.5, ВА.2.75 («Кентавр»).

Цель исследования – на основании проспективного наблюдательного исследования оценить эффективность и безопасность тиксагевимаба и цилгавимаба (ТЦ) для доконтактной профилактики COVID-19 у ревматологических пациентов, получающих ритуксимаб.

Материал и методы

Материал и методы. В основную группу вошли 86 пациентов с различными ИВРЗ, получающих лечение РТМ. Медиана возраста составила 59 (19–82) лет; соотношение мужчины : женщины (М:Ж) – 1:1,8. В 50 случаях диагностирован системный васкулит, ассоциированный с антителами к цитоплазме нейтрофилов (АНЦА-СВ), в 15 – ревматоидный артрит (РА), в 9 – синдром Шегрена (СШ), в 4 – IgG4-связанное заболевание (IgG4-СЗ), в 3 – системная красная волчанка (СКВ), в 3 – дерматомиозит (ДМ), в 2 – системная склеродермия (ССД). С 26 марта по 30 августа 2022 г. пациентам однократно вводили ТЦ внутримышечно в суммарной дозе 300 мг преимущественно после РТМ (в 52% случаев; у 28% – на следующий день после РТМ). В контрольную группу вошли 42 пациента с АНЦА-СВ (медиана возраста – 45 (35– 71) лет; М:Ж = 1:1), получавших лечение РТМ, которым не проводили доконтактную профилактику ТЦ. Продолжительность наблюдения составила 7 месяцев – до 1 ноября 2022 г. В этот период 98% подтвержденных случаев коронавируса в РФ приходились на штамм Омикрон. Был проведен телефонный и/или онлайн-опрос пациентов для выявления случаев COVID-19 и нежелательных реакций (НР).

Результаты

Результаты. В группе ТЦ коронавирусная инфекция, подтвержденная методом полимеразной цепной реакции (ПЦР), выявлена у 17 (20%) пациентов (АНЦА-СВ – 10; СШ – 3; ССД – 2; СКВ – 1; ДМ – 1) с повышением температуры тела у 7 (8%); только в одном случае потребовалась госпитализация, при этом поражения легких при компьютерной томографии (КТ) выявлено не было. В двух случаях по данным КТ наблюдалось нетяжелое поражение легких (КТ 1–2). Летальные исходы отсутствовали. Отмечена хорошая переносимость ТЦ; серьезные нежелательные реакции отсутствовали; проявления, не связанные с COVID-19 или с прогрессированием ИВРЗ, после введения ТЦ отмечены у 8 (9%) пациентов (гранулематоз с полиангиитом – 3; микроскопический полиангиит – 1; РА – 2; СКВ – 1; IgG4-СЗ – 1); при этом реакций, определенно связанных с применением ТЦ, не выявлено. Наиболее серьезным явлением, не связанным с COVID-19, было прогрессирование полинейропатии у пациента с РА. В контрольной группе у 3 (7%) пациентов диагностирован COVID-19, подтвержденный методом ПЦР, у одного – с тяжелым поражением легких (КТ 3, тромбоэмболия легочной артерии) и летальным исходом.

Заключение

Заключение. Данные клинических исследований и представленный впервые в РФ клинический опыт свидетельствуют об эффективности применения у пациентов с ИВРЗ комбинации моноклональных антител длительного действия ТЦ (Эвушелд), зарегистрированных по показаниям доконтактной профилактики и лечения COVID-19. У пациентов с ИВРЗ, получающих лечение РТМ, отмечен благоприятный профиль безопасности ТЦ. Вируснейтрализующие моноклональные антитела, препараты нового класса для профилактики и лечения инфекционных заболеваний, открывают значительные перспективы для улучшения прогноза больных ИВРЗ.  

The problem of prevention of coronavirus disease 2019 (COVID-19) in patients with immune-mediated inflammatory rheumatic diseases (IMRD) remains highly relevant. The presence of IRD is associated with a high risk of disease and severe course of COVID-19 during immunosuppressive treatment, primarily anti-B cell therapy with rituximab (RTX), and a low level of post-vaccination response in such patients. A new strategy for the prevention and treatment of COVID-19 are virus-neutralizing monoclonal antibodies to coronavirus; currently, combined long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld) are registered for prevention in the world and the Russian Federation. . Tixagevimab and cilgavimab (TC) show neutralizing activity against SARS-CoV-2, including the Omicron strain, primarily its variants BA.4, BA.5, BA.2.75 ("Centaur").

Objective – to evaluate the efficacy and safety of TC for pre-exposure prophylaxis of COVID-19 in rheumatic patients receiving RTX, based on a prospective observational study.

Materials and methods

Materials and methods. The main group included 86 patients with various IMRD receiving RTX: 50 of them had ANCA-associated systemic vasculitis (AAV), 15 – rheumatoid arthritis, 9 – Sjogren’s syndrome (SS), 4 – IgG4-related disease, 3 – systemic lupus erythematosus (SLE), 3 – dermatomyositis (DM), 2 – systemic scleroderma (SSD). Median age was 59 (19–82) years; male : female ratio – 1:1,8. From March 26 to August 30 2022, patients received a single intramuscular injection of TC in a total dose of 300 mg, mainly after RTX (in 52% of cases, in 28% on the next day after RTX). The control group included 42 patients with AAV (median age – 45 (35–71) years; male : female ratio – 1:1), also treated with RTX, who did not receive pre-exposure prophylaxis of TC. The duration of observation was 7 months, until November 1 2022. At this time, 98% of confirmed cases of coronavirus in the Russian Federation were Omicron. A telephone and/or online survey of patient has been conducted to detect cases of COVID-19 and adverse reactions.

Results

Results. In the TC group, confirmed coronavirus infection have been detected in 17 (20%) patients (AAV – 10, SS – 3, SSD – 2, SLE – 1, DM – 1), with fever in 7 (8%), only in one case hospitalization was required (lung damage was not detected in computed tomography), in two cases, according to CT mild lung damage (CT 1–2), there were no deaths. Good TC’s tolerability was noted, signs not associated with COVID-19 or progression of IMRD after administration of TC were observed in 8 (9%) patients (GPA – 3 MPA – 1, RA – 2, SLE – 1, IgG4-related disease – 1), adverse reactions definitely associated with the use of TC were not found. The most serious event not associated with coronavirus infection was the progression of polyneuropathy in a patient with RA. In the control group, 3 (7%) patients were diagnosed with COVID-19, one with severe lung injury (CT 3, pulmonary embolism) and death.

Conclusions

Conclusions. The data of clinical studies and our own clinical experience evidence the effectiveness of the use of a combination of long-acting monoclonal antibodies TC (Evusheld), registered for indications for pre-exposure prophylaxis and treatment of COVID-19. Patients with IMRD treated with RTX have a favorable safety profile of TC. The introduction of virus-neutralizing monoclonal antibodies, a new drug class for the prevention and treatment of infectious diseases, opens significant prospects for improving the prognosis of patients with IRD.

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The authors declare that there are no conflicts of interest present.