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Доконтактная профилактика новой коронавирусной инфекции COVID-19 препаратом тиксагевимаб/ цилгавимаб у взрослых московских пациентов с первичными иммунодефицитами
Доконтактная профилактика новой коронавирусной инфекции COVID-19 препаратом тиксагевимаб/ цилгавимаб у взрослых московских пациентов с первичными иммунодефицитами
Роппельт А.А., Лебедкина М.С., Чернов А.А., Круглова Т.С., Мухина О.А., Юхновская Ю.Д., Самедова Ф.С., Маркина У.А., Андренова Г.В., Караулов А.В., Лысенко М.А., Фомина Д.С. Доконтактная профилактика новой коронавирусной инфекции COVID-19 препаратом тиксагевимаб/цилгавимаб у взрослых московских пациентов с первичными иммунодефицитами. Терапевтический архив. 2023;95(1):78–84.
DOI: 10.26442/00403660.2023.01.202088
© ООО «КОНСИЛИУМ МЕДИКУМ», 2023 г.
DOI: 10.26442/00403660.2023.01.202088
© ООО «КОНСИЛИУМ МЕДИКУМ», 2023 г.
________________________________________________
Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Аннотация
Обоснование. Первичные иммунодефициты (ПИД), известные на сегодняшний день как врожденные дефекты иммунитета, – группа наследственных заболеваний, обусловленных дефектами генов, контролирующих иммунный ответ. Пациенты с ПИД имеют риски развития тяжелого течения и/или летального исхода при заболевании COVID-19. В качестве доконтактной профилактики у пациентов с ПИД следует рассмотреть вариант пассивной иммунизации препаратами моноклональных антител (МАТ) к SARS-CoV-2 длительного действия. Тиксагевимаб/цилгавимаб – комбинация МАТ, которые связываются с шиповидным белком SARS-CoV-2.
Цель. Оценить эффективность и безопасность доконтактной профилактики новой коронавирусной инфекции SARS-CoV-2 комбинацией тиксагевимаба/цилгавимаба у пациентов с ПИД.
Материалы и методы. В исследование включены 48 пациентов с диагнозом ПИД. Медиана наблюдения после введения препарата – 174 дня. Оценивалось общее количество подтвержденных случаев коронавирусной инфекции у пациентов с ПИД, а также за 6 мес до и после введения МАТ.
Результаты. В изучаемой когорте общая частота возникновения COVID-19 с начала пандемии до введения МАТ cоставила 75% (36/48), 31% (11/36) переболевших пациентов перенесли инфекцию неоднократно. Частота возникновения COVID-19 непосредственно за полгода до введения тиксагевимаба/цилгавимаба составила 40%. Все пациенты, заболевшие COVID-19 после проведения доконтактной профилактики, перенесли инфекцию в легкой форме. Частота возникновения COVID-19 в течение полугода после введения тиксагевимаба/цилгавимаба достоверно снизилась в сравнении с частотой за 6 мес до введения (7 и 40% соответственно; p<0,001).
Заключение. Применение тиксагевимаба/цилгавимаба у пациентов с ПИД эффективно в качестве доконтактной профилактики, снижает риск развития тяжелой формы COVID-19.
Ключевые слова: первичные иммунодефициты, доконтактная профилактика, тиксагевимаб/цилгавимаб, COVID-19
Aim. To evaluate the efficacy and safety of pre-exposure prophylaxis of new SARS-CoV-2 infection in PIDs with the combination of tixagevimab/cilgavimab.
Materials and methods. Forty eight patients diagnosed with PIDs were included in the study. Median follow-up after drug administration was 174 days. The total number of confirmed coronavirus infections in patients with PIDs as well as 6 months before and after administration of MAT were assessed.
Results. In the analyzed cohort, the overall incidence of COVID-19 from pandemic onset to MABs administration was 75% (36/48), with 31% (11/36) of over-infected patients having had the infection more than once. The incidence of COVID-19 immediately 6 months before the introduction of tixagevimab/cilgavimab was 40%. All patients who had COVID-19 after pre-exposure prophylaxis had a mild infection. The incidence of COVID-19 6 months after tixagevimab/cilgavimab administration significantly decreased compared to the incidence 6 months before administration (7 and 40%, respectively; p<0.001).
Conclusion. The use of tixagevimab/cilgavimab in patients with PIDs is effective as pre-exposure prophylaxis and reduces the risk of severe COVID-19.
Keywords: primary immunodeficiencies, pre-exposure prophylaxis, tixagevimab/cilgavimab, COVID-19
Цель. Оценить эффективность и безопасность доконтактной профилактики новой коронавирусной инфекции SARS-CoV-2 комбинацией тиксагевимаба/цилгавимаба у пациентов с ПИД.
Материалы и методы. В исследование включены 48 пациентов с диагнозом ПИД. Медиана наблюдения после введения препарата – 174 дня. Оценивалось общее количество подтвержденных случаев коронавирусной инфекции у пациентов с ПИД, а также за 6 мес до и после введения МАТ.
Результаты. В изучаемой когорте общая частота возникновения COVID-19 с начала пандемии до введения МАТ cоставила 75% (36/48), 31% (11/36) переболевших пациентов перенесли инфекцию неоднократно. Частота возникновения COVID-19 непосредственно за полгода до введения тиксагевимаба/цилгавимаба составила 40%. Все пациенты, заболевшие COVID-19 после проведения доконтактной профилактики, перенесли инфекцию в легкой форме. Частота возникновения COVID-19 в течение полугода после введения тиксагевимаба/цилгавимаба достоверно снизилась в сравнении с частотой за 6 мес до введения (7 и 40% соответственно; p<0,001).
Заключение. Применение тиксагевимаба/цилгавимаба у пациентов с ПИД эффективно в качестве доконтактной профилактики, снижает риск развития тяжелой формы COVID-19.
Ключевые слова: первичные иммунодефициты, доконтактная профилактика, тиксагевимаб/цилгавимаб, COVID-19
________________________________________________
Aim. To evaluate the efficacy and safety of pre-exposure prophylaxis of new SARS-CoV-2 infection in PIDs with the combination of tixagevimab/cilgavimab.
Materials and methods. Forty eight patients diagnosed with PIDs were included in the study. Median follow-up after drug administration was 174 days. The total number of confirmed coronavirus infections in patients with PIDs as well as 6 months before and after administration of MAT were assessed.
Results. In the analyzed cohort, the overall incidence of COVID-19 from pandemic onset to MABs administration was 75% (36/48), with 31% (11/36) of over-infected patients having had the infection more than once. The incidence of COVID-19 immediately 6 months before the introduction of tixagevimab/cilgavimab was 40%. All patients who had COVID-19 after pre-exposure prophylaxis had a mild infection. The incidence of COVID-19 6 months after tixagevimab/cilgavimab administration significantly decreased compared to the incidence 6 months before administration (7 and 40%, respectively; p<0.001).
Conclusion. The use of tixagevimab/cilgavimab in patients with PIDs is effective as pre-exposure prophylaxis and reduces the risk of severe COVID-19.
Keywords: primary immunodeficiencies, pre-exposure prophylaxis, tixagevimab/cilgavimab, COVID-19
Полный текст
Список литературы
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17. Alhumaid S, Al Mutair A, Alali J, et al. Efficacy and Safety of Tixagevimab/Cilgavimab to Prevent COVID-19 (Pre-Exposure Prophylaxis): A Systematic Review and Meta-Analysis. Diseases. 2022;10(4):118. DOI:10.3390/diseases10040118
18. Информационный бюллетень для медицинских работников: разрешение на экстренное применение лекарственного препарата эвушелд™ (evusheld™) (тиксагевимаб + цилгавимаб [набор]). Режим доступа: https://www.evusheldpi.com/content/dam/microsites/evusheld-elabelling/russia/pdf/Clean-Fact%20Sheet-... Ссылка активна на 20.01.2023 [Fact Sheet for Healthcare Professionals: Emergency Use Authorization for Evusheld™ (Tixagevimab + Cilgavimab [Kit]). Available at: https://www.evusheldpi.com/content/dam/microsites/evusheld-elabelling/russia/pdf/Clean-Fact%20Sheet-... Accessed: 20.01.2023 (in Russian)].
19. Nguyen Y, Flahault A, Chavarot N, et al. Pre-exposure prophylaxis with tixagevimab and cilgavimab (Evusheld) for COVID-19 among 1112 severely immunocompromised patients. Clin Microbiol Infect. 2022;28(12):1654.e1-e4. DOI:10.1016/j.cmi.2022.07.015
20. Totschnig D, Augustin M, Niculescu Iu, et al. SARS-CoV-2 Pre-Exposure Prophylaxis with Sotrovimab and Tixagevimab/Cilgavimab in Immunocompromised Patients-A Single-Center Experience. Viruses. 2022;14(10):2278. DOI:10.3390/v14102278
21. Calabrese C, Kirchner E, Villa-Forte A, et al. Early experience with tixagevimab/cilgavimab pre-exposure prophylaxis in patients with immune-mediated inflammatory disease undergoing B cell depleting therapy and those with inborn errors of humoral immunity. RMD Open. 2022;8(2):e002557. DOI:10.1136/rmdopen-2022-002557
22. Johnson S, Fernandez J. Incidence of COVID-19 infections in adults with primary immunodeficiency after receiving tixagevimab and cilgavimab. Ann Allergy Asthma Immunol. 2022;129(5):S54. DOI:10.1016/j.anai.2022.08.652
23. Jones JM, Faruqi AJ, Sullivan JK, et al. COVID-19 Outcomes in Patients Undergoing B Cell Depletion Therapy and Those with Humoral Immunodeficiency States: A Scoping Review. Pathog Immun. 2021;6(1):76-103. DOI:10.20411/pai.v6i1.435
24. Cook C, Patel NJ, D`Silva KM, et al. Clinical characteristics and outcomes of COVID-19 breakthrough infections among vaccinated patients with systemic autoimmune rheumatic diseases. Ann Rheum Dis. 2022;81(2):289-91. DOI:10.1136/annrheumdis-2021-221326
2. Kan NYu, Mukhina AA, Rodina YuA, et al. COVID-19 infection in patients with primary immunodeficiencies. Pediatria n.a. G.N. Speransky. 2020;99(6):83-90. (in Russian). DOI:10.24110/0031-403X-2020-99-6-83-90
3. Meyts I, Bucciol G, Quinti I, et al. Coronavirus disease 2019 in patients with inborn errors of immunity: an international study. J Allergy Clin Immunol. 2021;147(2):520-31. DOI:10.1016/j.jaci.2020.09.010
4. Delavari S, Abolhassani H, Abolnezhadian F, et al. A. Impact of SARS-CoV-2 Pandemic on Patients with Primary Immunodeficiency. J Clin Immunol. 2021;41(2):345-55. DOI:10.1007/s10875-020-00928-x
5. Milota T, Sobotková M, Smetanova J, et al. Risk Factors for Severe COVID-19 and Hospital Admission in Patients With Inborn Errors of Immunity – Results From a Multicenter Nationwide Study. Front Immunol. 2022;13:835770. DOI:10.3389/fimmu.2022.835770
6. Milito C, Lougaris V, Giardino G, et al. Clinical outcome, incidence, and SARS-CoV-2 infection-fatality rates in Italian patients with inborn errors of immunity. J Allergy Clin Immunol Pract. 2021;9(7):2904-6.e2. DOI:10.1016/j.jaip.2021.04.017
7. Karakoc Aydiner E, Bilgic Eltan S, Babayeva R, et al. Adverse COVID-19 outcomes in immune deficiencies: Inequality exists between subclasses. Allergy. 2022;77(1):282-95. DOI:10.1111/all.15025
8. Drzymalla E, Green RF, Knuth M, et al. A. COVID-19-related health outcomes in people with primary immunodeficiency: A systematic review. Clin Immunol. 2022;243:109097. DOI:10.1016/j.clim.2022.109097
9. Durkee-Shock JR, Keller MD. Immunizing the imperfect immune system: Coronavirus disease 2019 vaccination in patients with inborn errors of immunity. Ann Allergy Asthma Immunol. 2022;129(5):562-71.e1. DOI:10.1016/j.anai.2022.06.009
10. Temporary guidelines. Prevention, diagnosis, and treatment of novel coronavirus infection (COVID-19). Version 17 (12/14/2022). Available at: https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/061/254/original/%D0%92%D0%9C%D0%A0.... Accessed: 20.01.2023 (in Russian).
11. Liu C, Ginn HM, Dejnirattisai W, et al. Reduced neutralization of SARS-CoV-2 B.1.617 by vaccine and convalescent serum. Cell. 2021;184(16):4220-36.e13. DOI:10.1016/j.cell.2021.06.020
12. Dong J, Zost SJ, Graney AJ, et al. Genetic and structural basis for SARS-CoV-2 variant neutralization by a two-antibody cocktail. Nat Microbiol. 2021;6(10):1233-44. DOI:10.1038/s41564-021-00972-2
13. Touret F, Baronti C, Pastorino B, et al. In vitro activity of therapeutic antibodies against SARS-CoV-2 Omicron BA.1, BA.2 and BA.5. Sci Rep. 2022;12(1):12609.
DOI:10.1038/s41598-022-16964-z
14. Tuekprakhon A, Nutalai R, Dijokaite-Guraliuc A, et al. Antibody escape of SARS-CoV-2 Omicron BA.4 and BA.5 from vaccine and BA.1 serum. Cell. 2022;185(14):2422-33.e13. DOI:10.1016/j.cell.2022.06.005
15. Loo YM, McTamney PM, Arends RH, et al. The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans. Sci Transl Med. 2022;14(635):eabl8124. DOI:10.1126/scitranslmed.abl8124
16. Levin MJ, Ustianowski A, De Wit S, et al. PROVENT Study Group. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19. N Engl J Med. 2022;386(23):2188-200. DOI:10.1056/NEJMoa2116620
17. Alhumaid S, Al Mutair A, Alali J, et al. Efficacy and Safety of Tixagevimab/Cilgavimab to Prevent COVID-19 (Pre-Exposure Prophylaxis): A Systematic Review and Meta-Analysis. Diseases. 2022;10(4):118. DOI:10.3390/diseases10040118
18. Fact Sheet for Healthcare Professionals: Emergency Use Authorization for Evusheld™ (Tixagevimab + Cilgavimab [Kit]). Available at: https://www.evusheldpi.com/content/dam/microsites/evusheld-elabelling/russia/pdf/Clean-Fact%20Sheet-... Accessed: 20.01.2023 (in Russian).
19. Nguyen Y, Flahault A, Chavarot N, et al. Pre-exposure prophylaxis with tixagevimab and cilgavimab (Evusheld) for COVID-19 among 1112 severely immunocompromised patients. Clin Microbiol Infect. 2022;28(12):1654.e1-e4. DOI:10.1016/j.cmi.2022.07.015
20. Totschnig D, Augustin M, Niculescu Iu, et al. SARS-CoV-2 Pre-Exposure Prophylaxis with Sotrovimab and Tixagevimab/Cilgavimab in Immunocompromised Patients-A Single-Center Experience. Viruses. 2022;14(10):2278. DOI:10.3390/v14102278
21. Calabrese C, Kirchner E, Villa-Forte A, et al. Early experience with tixagevimab/cilgavimab pre-exposure prophylaxis in patients with immune-mediated inflammatory disease undergoing B cell depleting therapy and those with inborn errors of humoral immunity. RMD Open. 2022;8(2):e002557. DOI:10.1136/rmdopen-2022-002557
22. Johnson S, Fernandez J. Incidence of COVID-19 infections in adults with primary immunodeficiency after receiving tixagevimab and cilgavimab. Ann Allergy Asthma Immunol. 2022;129(5):S54. DOI:10.1016/j.anai.2022.08.652
23. Jones JM, Faruqi AJ, Sullivan JK, et al. COVID-19 Outcomes in Patients Undergoing B Cell Depletion Therapy and Those with Humoral Immunodeficiency States: A Scoping Review. Pathog Immun. 2021;6(1):76-103. DOI:10.20411/pai.v6i1.435
24. Cook C, Patel NJ, D`Silva KM, et al. Clinical characteristics and outcomes of COVID-19 breakthrough infections among vaccinated patients with systemic autoimmune rheumatic diseases. Ann Rheum Dis. 2022;81(2):289-91. DOI:10.1136/annrheumdis-2021-221326
2. Кан Н.Ю., Мухина А.А., Родина Ю.А. и др. Течение инфекции COVID-19 у пациентов с первичными иммунодефицитными состояниями. Педиатрия им. Г.Н. Сперанского. 2020;99(6):83-90 [Kan NYu, Mukhina AA, Rodina YuA, et al. COVID-19 infection in patients with primary immunodeficiencies. Pediatria n.a. G.N. Speransky. 2020;99(6):83-90. (in Russian)]. DOI:10.24110/0031-403X-2020-99-6-83-90
3. Meyts I, Bucciol G, Quinti I, et al. Coronavirus disease 2019 in patients with inborn errors of immunity: an international study. J Allergy Clin Immunol. 2021;147(2):520-31. DOI:10.1016/j.jaci.2020.09.010
4. Delavari S, Abolhassani H, Abolnezhadian F, et al. A. Impact of SARS-CoV-2 Pandemic on Patients with Primary Immunodeficiency. J Clin Immunol. 2021;41(2):345-55. DOI:10.1007/s10875-020-00928-x
5. Milota T, Sobotková M, Smetanova J, et al. Risk Factors for Severe COVID-19 and Hospital Admission in Patients With Inborn Errors of Immunity – Results From a Multicenter Nationwide Study. Front Immunol. 2022;13:835770. DOI:10.3389/fimmu.2022.835770
6. Milito C, Lougaris V, Giardino G, et al. Clinical outcome, incidence, and SARS-CoV-2 infection-fatality rates in Italian patients with inborn errors of immunity. J Allergy Clin Immunol Pract. 2021;9(7):2904-6.e2. DOI:10.1016/j.jaip.2021.04.017
7. Karakoc Aydiner E, Bilgic Eltan S, Babayeva R, et al. Adverse COVID-19 outcomes in immune deficiencies: Inequality exists between subclasses. Allergy. 2022;77(1):282-95. DOI:10.1111/all.15025
8. Drzymalla E, Green RF, Knuth M, et al. A. COVID-19-related health outcomes in people with primary immunodeficiency: A systematic review. Clin Immunol. 2022;243:109097. DOI:10.1016/j.clim.2022.109097
9. Durkee-Shock JR, Keller MD. Immunizing the imperfect immune system: Coronavirus disease 2019 vaccination in patients with inborn errors of immunity. Ann Allergy Asthma Immunol. 2022;129(5):562-71.e1. DOI:10.1016/j.anai.2022.06.009
10. Временные методические рекомендации. Профилактика, диагностика и лечение новой коронавирусной инфекции (COVID-19). Версия 17 (14.12.2022). Режим доступа: https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/061/254/original/%D0%92%D0%9C%D0%A0.... Ссылка активна на 20.01.2023 [Temporary guidelines. Prevention, diagnosis, and treatment of novel coronavirus infection (COVID-19). Version 17 (12/14/2022). Available at: https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/061/254/original/%D0%92%D0%9C%D0%A0.... Accessed: 20.01.2023 (in Russian)].
11. Liu C, Ginn HM, Dejnirattisai W, et al. Reduced neutralization of SARS-CoV-2 B.1.617 by vaccine and convalescent serum. Cell. 2021;184(16):4220-36.e13. DOI:10.1016/j.cell.2021.06.020
12. Dong J, Zost SJ, Graney AJ, et al. Genetic and structural basis for SARS-CoV-2 variant neutralization by a two-antibody cocktail. Nat Microbiol. 2021;6(10):1233-44. DOI:10.1038/s41564-021-00972-2
13. Touret F, Baronti C, Pastorino B, et al. In vitro activity of therapeutic antibodies against SARS-CoV-2 Omicron BA.1, BA.2 and BA.5. Sci Rep. 2022;12(1):12609.
DOI:10.1038/s41598-022-16964-z
14. Tuekprakhon A, Nutalai R, Dijokaite-Guraliuc A, et al. Antibody escape of SARS-CoV-2 Omicron BA.4 and BA.5 from vaccine and BA.1 serum. Cell. 2022;185(14):2422-33.e13. DOI:10.1016/j.cell.2022.06.005
15. Loo YM, McTamney PM, Arends RH, et al. The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans. Sci Transl Med. 2022;14(635):eabl8124. DOI:10.1126/scitranslmed.abl8124
16. Levin MJ, Ustianowski A, De Wit S, et al. PROVENT Study Group. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19. N Engl J Med. 2022;386(23):2188-200. DOI:10.1056/NEJMoa2116620
17. Alhumaid S, Al Mutair A, Alali J, et al. Efficacy and Safety of Tixagevimab/Cilgavimab to Prevent COVID-19 (Pre-Exposure Prophylaxis): A Systematic Review and Meta-Analysis. Diseases. 2022;10(4):118. DOI:10.3390/diseases10040118
18. Информационный бюллетень для медицинских работников: разрешение на экстренное применение лекарственного препарата эвушелд™ (evusheld™) (тиксагевимаб + цилгавимаб [набор]). Режим доступа: https://www.evusheldpi.com/content/dam/microsites/evusheld-elabelling/russia/pdf/Clean-Fact%20Sheet-... Ссылка активна на 20.01.2023 [Fact Sheet for Healthcare Professionals: Emergency Use Authorization for Evusheld™ (Tixagevimab + Cilgavimab [Kit]). Available at: https://www.evusheldpi.com/content/dam/microsites/evusheld-elabelling/russia/pdf/Clean-Fact%20Sheet-... Accessed: 20.01.2023 (in Russian)].
19. Nguyen Y, Flahault A, Chavarot N, et al. Pre-exposure prophylaxis with tixagevimab and cilgavimab (Evusheld) for COVID-19 among 1112 severely immunocompromised patients. Clin Microbiol Infect. 2022;28(12):1654.e1-e4. DOI:10.1016/j.cmi.2022.07.015
20. Totschnig D, Augustin M, Niculescu Iu, et al. SARS-CoV-2 Pre-Exposure Prophylaxis with Sotrovimab and Tixagevimab/Cilgavimab in Immunocompromised Patients-A Single-Center Experience. Viruses. 2022;14(10):2278. DOI:10.3390/v14102278
21. Calabrese C, Kirchner E, Villa-Forte A, et al. Early experience with tixagevimab/cilgavimab pre-exposure prophylaxis in patients with immune-mediated inflammatory disease undergoing B cell depleting therapy and those with inborn errors of humoral immunity. RMD Open. 2022;8(2):e002557. DOI:10.1136/rmdopen-2022-002557
22. Johnson S, Fernandez J. Incidence of COVID-19 infections in adults with primary immunodeficiency after receiving tixagevimab and cilgavimab. Ann Allergy Asthma Immunol. 2022;129(5):S54. DOI:10.1016/j.anai.2022.08.652
23. Jones JM, Faruqi AJ, Sullivan JK, et al. COVID-19 Outcomes in Patients Undergoing B Cell Depletion Therapy and Those with Humoral Immunodeficiency States: A Scoping Review. Pathog Immun. 2021;6(1):76-103. DOI:10.20411/pai.v6i1.435
24. Cook C, Patel NJ, D`Silva KM, et al. Clinical characteristics and outcomes of COVID-19 breakthrough infections among vaccinated patients with systemic autoimmune rheumatic diseases. Ann Rheum Dis. 2022;81(2):289-91. DOI:10.1136/annrheumdis-2021-221326
________________________________________________
2. Kan NYu, Mukhina AA, Rodina YuA, et al. COVID-19 infection in patients with primary immunodeficiencies. Pediatria n.a. G.N. Speransky. 2020;99(6):83-90. (in Russian). DOI:10.24110/0031-403X-2020-99-6-83-90
3. Meyts I, Bucciol G, Quinti I, et al. Coronavirus disease 2019 in patients with inborn errors of immunity: an international study. J Allergy Clin Immunol. 2021;147(2):520-31. DOI:10.1016/j.jaci.2020.09.010
4. Delavari S, Abolhassani H, Abolnezhadian F, et al. A. Impact of SARS-CoV-2 Pandemic on Patients with Primary Immunodeficiency. J Clin Immunol. 2021;41(2):345-55. DOI:10.1007/s10875-020-00928-x
5. Milota T, Sobotková M, Smetanova J, et al. Risk Factors for Severe COVID-19 and Hospital Admission in Patients With Inborn Errors of Immunity – Results From a Multicenter Nationwide Study. Front Immunol. 2022;13:835770. DOI:10.3389/fimmu.2022.835770
6. Milito C, Lougaris V, Giardino G, et al. Clinical outcome, incidence, and SARS-CoV-2 infection-fatality rates in Italian patients with inborn errors of immunity. J Allergy Clin Immunol Pract. 2021;9(7):2904-6.e2. DOI:10.1016/j.jaip.2021.04.017
7. Karakoc Aydiner E, Bilgic Eltan S, Babayeva R, et al. Adverse COVID-19 outcomes in immune deficiencies: Inequality exists between subclasses. Allergy. 2022;77(1):282-95. DOI:10.1111/all.15025
8. Drzymalla E, Green RF, Knuth M, et al. A. COVID-19-related health outcomes in people with primary immunodeficiency: A systematic review. Clin Immunol. 2022;243:109097. DOI:10.1016/j.clim.2022.109097
9. Durkee-Shock JR, Keller MD. Immunizing the imperfect immune system: Coronavirus disease 2019 vaccination in patients with inborn errors of immunity. Ann Allergy Asthma Immunol. 2022;129(5):562-71.e1. DOI:10.1016/j.anai.2022.06.009
10. Temporary guidelines. Prevention, diagnosis, and treatment of novel coronavirus infection (COVID-19). Version 17 (12/14/2022). Available at: https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/061/254/original/%D0%92%D0%9C%D0%A0.... Accessed: 20.01.2023 (in Russian).
11. Liu C, Ginn HM, Dejnirattisai W, et al. Reduced neutralization of SARS-CoV-2 B.1.617 by vaccine and convalescent serum. Cell. 2021;184(16):4220-36.e13. DOI:10.1016/j.cell.2021.06.020
12. Dong J, Zost SJ, Graney AJ, et al. Genetic and structural basis for SARS-CoV-2 variant neutralization by a two-antibody cocktail. Nat Microbiol. 2021;6(10):1233-44. DOI:10.1038/s41564-021-00972-2
13. Touret F, Baronti C, Pastorino B, et al. In vitro activity of therapeutic antibodies against SARS-CoV-2 Omicron BA.1, BA.2 and BA.5. Sci Rep. 2022;12(1):12609.
DOI:10.1038/s41598-022-16964-z
14. Tuekprakhon A, Nutalai R, Dijokaite-Guraliuc A, et al. Antibody escape of SARS-CoV-2 Omicron BA.4 and BA.5 from vaccine and BA.1 serum. Cell. 2022;185(14):2422-33.e13. DOI:10.1016/j.cell.2022.06.005
15. Loo YM, McTamney PM, Arends RH, et al. The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans. Sci Transl Med. 2022;14(635):eabl8124. DOI:10.1126/scitranslmed.abl8124
16. Levin MJ, Ustianowski A, De Wit S, et al. PROVENT Study Group. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19. N Engl J Med. 2022;386(23):2188-200. DOI:10.1056/NEJMoa2116620
17. Alhumaid S, Al Mutair A, Alali J, et al. Efficacy and Safety of Tixagevimab/Cilgavimab to Prevent COVID-19 (Pre-Exposure Prophylaxis): A Systematic Review and Meta-Analysis. Diseases. 2022;10(4):118. DOI:10.3390/diseases10040118
18. Fact Sheet for Healthcare Professionals: Emergency Use Authorization for Evusheld™ (Tixagevimab + Cilgavimab [Kit]). Available at: https://www.evusheldpi.com/content/dam/microsites/evusheld-elabelling/russia/pdf/Clean-Fact%20Sheet-... Accessed: 20.01.2023 (in Russian).
19. Nguyen Y, Flahault A, Chavarot N, et al. Pre-exposure prophylaxis with tixagevimab and cilgavimab (Evusheld) for COVID-19 among 1112 severely immunocompromised patients. Clin Microbiol Infect. 2022;28(12):1654.e1-e4. DOI:10.1016/j.cmi.2022.07.015
20. Totschnig D, Augustin M, Niculescu Iu, et al. SARS-CoV-2 Pre-Exposure Prophylaxis with Sotrovimab and Tixagevimab/Cilgavimab in Immunocompromised Patients-A Single-Center Experience. Viruses. 2022;14(10):2278. DOI:10.3390/v14102278
21. Calabrese C, Kirchner E, Villa-Forte A, et al. Early experience with tixagevimab/cilgavimab pre-exposure prophylaxis in patients with immune-mediated inflammatory disease undergoing B cell depleting therapy and those with inborn errors of humoral immunity. RMD Open. 2022;8(2):e002557. DOI:10.1136/rmdopen-2022-002557
22. Johnson S, Fernandez J. Incidence of COVID-19 infections in adults with primary immunodeficiency after receiving tixagevimab and cilgavimab. Ann Allergy Asthma Immunol. 2022;129(5):S54. DOI:10.1016/j.anai.2022.08.652
23. Jones JM, Faruqi AJ, Sullivan JK, et al. COVID-19 Outcomes in Patients Undergoing B Cell Depletion Therapy and Those with Humoral Immunodeficiency States: A Scoping Review. Pathog Immun. 2021;6(1):76-103. DOI:10.20411/pai.v6i1.435
24. Cook C, Patel NJ, D`Silva KM, et al. Clinical characteristics and outcomes of COVID-19 breakthrough infections among vaccinated patients with systemic autoimmune rheumatic diseases. Ann Rheum Dis. 2022;81(2):289-91. DOI:10.1136/annrheumdis-2021-221326
Авторы
А.А. Роппельт*1,2, М.С. Лебедкина1, А.А. Чернов1,3, Т.С. Круглова1, О.А. Мухина1, Ю.Д. Юхновская4, Ф.С. Самедова4, У.А. Маркина1, Г.В. Андренова1, А.В. Караулов4, М.А. Лысенко1,5, Д.С. Фомина1,4
1 ГБУЗ «Городская клиническая больница №52» Департамента здравоохранения г. Москвы, Москва, Россия;
2 ФГБУ «Национальный медицинский исследовательский центр детской гематологии, онкологии и иммунологии им. Дмитрия Рогачева» Минздрава России, Москва, Россия;
3 ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия;
4 ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия;
5 ФГАОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава России, Москва, Россия
*roppelt_anna@mail.ru
1 City Clinical Hospital №52, Moscow, Russia;
2 Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology, Moscow, Russia;
3 Russian Medical Academy of Continuous Professional Education, Moscow, Russia;
4 Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;
5 Pirogov Russian National Research Medical University, Moscow, Russia
*roppelt_anna@mail.ru
1 ГБУЗ «Городская клиническая больница №52» Департамента здравоохранения г. Москвы, Москва, Россия;
2 ФГБУ «Национальный медицинский исследовательский центр детской гематологии, онкологии и иммунологии им. Дмитрия Рогачева» Минздрава России, Москва, Россия;
3 ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия;
4 ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия;
5 ФГАОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава России, Москва, Россия
*roppelt_anna@mail.ru
________________________________________________
1 City Clinical Hospital №52, Moscow, Russia;
2 Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology, Moscow, Russia;
3 Russian Medical Academy of Continuous Professional Education, Moscow, Russia;
4 Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;
5 Pirogov Russian National Research Medical University, Moscow, Russia
*roppelt_anna@mail.ru
Цель портала OmniDoctor – предоставление профессиональной информации врачам, провизорам и фармацевтам.