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1Academic Journal
Authors: T. V. Beketova, N. O. Levina, Yu. A. Uskova, I. V. Rozanova, M. V. Dubinskaia, S. A. Evdokimova, V. V. Babak, M. F. Beketova, A. V. Devyatkin, Т. В. Бекетова, Н. О. Левина, Ю. А. Ускова, И. В. Розанова, М. В. Дубинская, С. А. Евдокимова, В. В. Бабак, М. Ф. Бекетова, А. В. Девяткин
Source: Rheumatology Science and Practice; Vol 62, No 5 (2024); 465-473 ; Научно-практическая ревматология; Vol 62, No 5 (2024); 465-473 ; 1995-4492 ; 1995-4484
Subject Terms: иммуновоспалительные ревматические заболевания, Cilgavimab, virus-neutralizing monoclonal antibodies, COVID-19, rituximab, ANCA-associated systemic vasculitis, inflammatory rheumatic diseases, цилгавимаб, вируснейтрализующие моноклональные антитела, коронавирусная болезнь 2019, ритуксимаб, АНЦА-ассоциированный системный васкулит
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Relation: https://rsp.mediar-press.net/rsp/article/view/3632/2400; Keating SM, Higgins BW. New technologies in therapeutic antibody development: The next frontier for treating infectious diseases. Antiviral Res. 2024;227:105902. doi:10.1016/j.antiviral.2024.105902; Насонов ЕЛ. Пандемия коронавирусной болезни 2019 (COVID-19) и аутоиммунные ревматические заболевания: итоги и перспективы. Научно-практическая ревматология. 2024;62(1):32-54.; Venkat R, Wallace ZS, Sparks JA. Considerations for pharmacologic management of rheumatoid arthritis in the COVID-19 era: A narrative review. Curr Rheumatol Rep. 2023;25(11):236-245. doi:10.1007/s11926-023-01111-y; Singson JRC, Kirley PD, Pham H, Rothrock G, Armistead I, Meek J, et al. Factors associated with severe outcomes among immunocompromised adults hospitalized for COVID-19 – COVID-NET, 10 states, March 2020–February 2022. MMWR Morb Mortal Wkly Rep. 2022;71(27):878-884. doi:10.15585/mmwr.mm7127a3; Spiera R, Jinich S, Jannat-Khah D. Rituximab, but not other antirheumatic therapies, is associated with impaired serological response to SARS- CoV-2 vaccination in patients with rheumatic diseases. Ann Rheum Dis. 2021;80(10):1357-1359. doi:10.1136/annrheumdis-2021-220604; Насонов ЕЛ, Авдеева АС. Деплеция В-клеток при иммуново-спалительных ревматических заболеваниях и коронавирусная болезнь 2019 (COVID-19). Научно-практическая ревматология. 2021;59(4):384-393.; Куликов АН, Муравьева НВ, Белов БС. Факторы риска тяжелого течения COVID-19 у больных ревматическими заболеваниями. Научно-практическая ревматология. 2024;62(1):24-31.; Spelman T, Forsberg L, McKay K, Glaser A, Hillert J. Increased rate of hospitalisation for COVID-19 among rituximab-treated multiple sclerosis patients: A study of the Swedish multiple sclerosis registry. Mult Scler. 2022;28:1051-1059. doi:10.1177/13524585211026272; Singh N, Madhira V, Hu C, Olex AL, Bergquist T, Fitzgerald KC, et al. Rituximab is associated with worse COVID-19 outcomes in patients with rheumatoid arthritis: A retrospective, nationally sampled cohort study from the U.S. National COVID Cohort Collaborative (N3C). Semin Arthritis Rheum. 2023;58:152149. doi:10.1016/j.semarthrit.2022.152149; Meijer SE, Paran Y, Belkin A, Ben-Ami R, Maor Y, Nesher L, et al. Persistent COVID-19 in immunocompromised patients-Israeli society of infectious diseases consensus statement on diagnosis and management. Clin Microbiol Infect. 2024;30(8):1012-1017. doi:10.1016/j.cmi.2024.04.009; Feng S, Reid GE, Clark NM, Harrington A, Uprichard SL, Baker SC. Evidence of SARS-CoV-2 convergent evolution in immunosuppressed patients treated with antiviral therapies. Virol J. 2024;21(1):105. doi:10.1186/s12985-024-02378-y; US Food and Drug Administration. Fact sheet for healthcare providers: Emergency use authorization for Evusheld (tixagevimab copackaged with cilgavimab). 2023. URL: https://www.fda.gov/media/154701/download (Accessed: 15th June 2024); Временные методические рекомендации по профилактике, диагностике и лечению новой коронавирусной инфекции (COVID-19), версия 17. 2021.; Loo YM, McTamney PM, Arends RH, Abram ME, Aksyuk AA, Diallo S, 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; Levin MJ, Ustianowski A, De Wit S, Launay O, Avila M, Templeton A, et al.; PROVENT Study Group. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for prevention of Covid-19. N Engl J Med. 2022;386(23):2188-2200. doi:10.1056/NEJMoa2116620; Forte-Soto P, Albayaty M, Brooks D, Arends RH, Tillinghast J, Aksyuk AA, et al. Safety, tolerability and pharmacokinetics of halflife extended severe acute respiratory syndrome coronavirus 2 neutralizing monoclonal antibodies AZD7442 (Tixagevimab-Cilgavimab) in healthy adults. J Infect Dis. 2023;227(10):1153-1163. doi:10.1093/infdis/jiad014; Cox M, Peacock TP, Harvey WT, Hughes J, Wright DW; COVID-19 Genomics UK (COG-UK) Consortium, et al. SARSCoV-2 variant evasion of monoclonal antibodies based on in vitro studies. Nat Rev Microbiol. 2023;21(2):112-124. doi:10.1038/s41579-022-00809-7; Насонов ЕЛ, Бекетова ТВ, Решетняк ТМ, Лила АМ, Ананьева ЛП, Лисицина ТА, и др. Коронавирусная болезнь 2019 (COVID-19) и иммуновоспалительные ревматические заболевания: на перекрестке проблем тромбовоспаления и аутоиммунитета. Научно-практическая ревматология. 2020;58(4):353-367.; Бекетова ТВ, Левина НО, Дубинская МВ, Ускова ЮА, Розанова ИВ, Бабак ВВ, и др. Опыт применения тиксагевимаба и цилгавимаба (Эвушелд) у 86 ревматологических пациентов, получающих анти-В-клеточную терапию ритуксимабом. Научно-практическая ревматология. 2023;61(2):158-164.; Бекетова ТВ, Бабак ВВ, Супрун МД. Течение и исходы COVID-19 у пациентов с АНЦА-ассоциированными системными васкулитами, получающих лечение генно-инженерными биологическими препаратами (ритуксимаб, меполизумаб): итоги первых 8 месяцев пандемии. Научно-практическая ревматология. 2021;59(1):37-46.; Роппельт АА, Лебедкина МС, Чернов АА, Круглова ТС, Мухина ОА, Юхновская ЮД, и др. Доконтактная профилактика новой коронавирусной инфекции COVID-19 препаратом тиксагевимаб/цилгавимаб у взрослых московских пациентов с первичными иммунодефицитами. Терапевтический архив. 2023;95(1):78-84.; Najjar-Debbiny R, Gronich N, Weber G, Stein N, Saliba W. Effectiveness of Evusheld in immunocompromised patients: Propensity score-matched analysis. Clin Infect Dis. 2023;76(6):1067-1073. doi:10.1093/cid/ciac855; Литвинова МА, Буланов НМ, Новиков ПИ, Филатова ЕЕ, Скворцов АВ, Климкина ИС, и др. Применение тиксагевимаба и цилгавимаба (Эвушелд) для доконтактной профилактики COVID-19 у пациентов с АНЦА-ассоциированными васкулитами: проспективное исследование. Клиническая фармакология и терапия. 2023;32(4):24-29.; Sciascia S, Rilat MLA, Fenoglio R, Foddai SG, Radin M, Cecchi I, et al. Safety and efficacy of pre-exposure prophylaxis with tixagevimab/cilgavimab (Evusheld) in patients with glomerular diseases who received rituximab. Clin Kidney J. 2023;16(9):1465-1468. doi:10.1093/ckj/sfad111; Jakimovski D, Eckert SP, Mirmosayyeb O, Thapa S, Pennington P, Hojnacki D, et al. Tixagevimab and Cilgavimab (Evusheld ™) prophylaxis prevents breakthrough COVID-19 infections in immunosuppressed population: 6-month prospective study. Vaccines (Basel). 2023;11(2):350. doi:10.3390/vaccines11020350; Davis HE, McCorkell L, Vogel JM, Topol EJ. Long COVID: Major findings, mechanisms and recommendations. Nat Rev Microbiol. 2023;21(3):133-146. doi:10.1038/s41579-022-00846-2; Nalbandian A, Desai AD, Wan EY. Post-COVID-19 condition. Annu Rev Med. 2023;74:55-64. doi:10.1146/annurevmed-043021-030635; Бекетова МФ, Бабак ВВ, Супрун МД, Бекетова ТВ, Георгинова ОА. К вопросу поздних осложнений COVID-19 у пациентов с ревматическими заболеваниями. Научно-практическая ревматология. 2022;60(2):162-164.; McCarthy MW. Paxlovid as a potential treatment for long COVID. Expert Opin Pharmacother. 2023;24(17):1839-1843. doi:10.1080/14656566.2023.2262387; McCarthy MW. Intravenous immunoglobulin as a potential treatment for long COVID. Expert Opin Biol Ther. 2023;23(12):1211-1217. doi:10.1080/14712598.2023.2296569
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2Academic Journal
Authors: T. V. Beketova, N. О. Levina, M. V. Dubinskaia, Yu. A. Uskova, I. V. Rozanova, V. V. Babak, M. F. Beketova, T. N. Krasnova, Т. В. Бекетова, Н. О. Левина, М. В. Дубинская, Ю. А. Ускова, И. В. Розанова, В. В. Бабак, М. Ф. Бекетова, Т. Н. Краснова
Source: Rheumatology Science and Practice; Vol 61, No 2 (2023); 158-164 ; Научно-практическая ревматология; Vol 61, No 2 (2023); 158-164 ; 1995-4492 ; 1995-4484
Subject Terms: иммуновоспалительные ревматические заболевания, Cilgavimab, virus-neutralizing monoclonal antibodies, COVID-19, rituximab, ANCA-associated systemic vasculitis, inflammatory rheumatic diseases, цилгавимаб, вируснейтрализующие моноклональные антитела, коронавирусная болезнь 2019, ритуксимаб, АНЦА-ассоциированный системный васкулит
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Relation: https://rsp.mediar-press.net/rsp/article/view/3318/2271; Насонов ЕЛ, Бекетова ТВ, Решетняк ТМ, Лила АМ, Ананьева ЛП, Лисицына ТА, и др. Коронавирусная болезнь 2019 (COVID-19) и иммуновоспалительные ревматические заболевания: на перекрестке проблем тромбовоспаления и аутоиммунитета. Научно-практическая ревматология. 2020;58(4):353-367. doi:10.47360/1995-4484-2020-353-367; Herishanu Y, Avivi I, Aharon A, Shefer G, Levi S, Bronstein Y, et al. Efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia. Blood. 2021;137(23):3165-3173. doi:10.1182/blood.2021011568; De Santis M, Motta F, Isailovic N, Clementi M, Criscuolo E, Clementi N, et al. Dose-dependent impairment of the immune response to the Moderna-1273 mRNA vaccine by mycophenolate mofetil in patients with rheumatic and autoimmune liver diseases. Vaccines (Basel). 2022;10(5):801. doi:10.3390/vaccines10050801; Singson JRC, Kirley PD, Pham H, Rothrock G, Armistead I, Meek J, et al. Factors associated with severe outcomes among immunocompromised adults hospitalized for COVID-19 – COVID-NET, 10 states, March 2020–February 2022. MMWR Morb Mortal Wkly Rep. 2022;71(27):878-884. doi:10.15585/mmwr.mm7127a3; Strohl WR, Ku Z, An Z, Carroll SF, Keyt BA, Strohl LM. Passive immunotherapy against SARS-CoV-2: From plasma-based therapy to single potent antibodies in the race to stay ahead of the variants. BioDrugs. 2022;36(3):231-323. doi:10.1007/s40259-022-00529-7; Phase III double-blind, placebo-controlled study of AZD7442 for post-exposure prophylaxis of COVID-19 in adults (STORM CHASER). 2020. URL: https://clinicaltrials.gov/ct2/show/NCT04625972 (Accessed: 25th October 2022).; Phase III double-blind, placebo-controlled study of AZD7442 for pre-exposure prophylaxis of COVID-19 in adult (PROVENT). 2020. URL: https://clinicaltrials.gov/ct2/show/NCT04625725 (Accessed: 20th December 2022).; US Food and Drug Administration. Fact sheet for healthcare providers: Emergency use authorization for Evusheld (tixagevimab copackaged with cilgavimab). URL: https://www.fda.gov/media/154701/download (Accessed: 22nd August 2022).; Временные методические рекомендации по профилактике, диагностике и лечению новой коронавирусной инфекции (COVID-19), версия 17. URL: https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/061/254/original/%D0%92%D0%9C%D0%A0_COVID-19_V17.pdf?1671088207 (Дата доступа: 16 декабря 2022).; Zost SJ, Gilchuk P, Case JB, Binshtein E, Chen RE, Nkolola JP, et al. Potently neutralizing and protective human antibodies against SARS-CoV-2. Nature. 2020;584(7821):443-449. doi:10.1038/s41586-020-2548-6; Zost SJ, Gilchuk P, Chen RE, Case JB, Reidy JX, Trivette A, et al. Rapid isolation and profiling of a diverse panel of human monoclonal antibodies targeting the SARS-CoV-2 spike protein. Nat Med. 2020;26(9):1422-1427. doi:10.1038/s41591-020-0998-x; Loo YM, McTamney PM, Arends RH, Abram ME, Aksyuk AA, Diallo S, 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; Dong J, Zost SJ, Greaney AJ, Starr TN, Dingens AS, Chen EC, et al. Genetic and structural basis for SARS-CoV-2 variant neutralization by a two-antibody cocktail. Nat Microbiol. 2021;6(10):1233-1244. doi:10.1038/s41564-021-00972-2; Oganesyan V, Gao C, Shirinian L, Wu H, Dall’Acqua WF. Structural characterization of a human Fc fragment engineered for lack of effector functions. Acta Crystallogr D Biol Crystallogr. 2008;64(Pt 6):700-704. doi:10.1107/S0907444908007877; Farshadpour F, Taherkhani R. Antibody-dependent enhancement and the critical pattern of COVID-19: Possibilities and considerations. Med Princ Pract. 2021;9:212-219. doi:10.1159/000516693; Dall’Acqua WF, Kiener PA, Wu H. Properties of human IgG1s engineered for enhanced binding to the neonatal Fc receptor (FcRn). J Biol Chem. 2006;281(33):23514-23524. doi:10.1074/jbc.M604292200; Robbie GJ, Criste R, Dall’acqua WF, Jensen K, Patel NK, Losonsky GA, et al. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother. 2013;57(12):6147-6153. doi:10.1128/AAC.01285-13; ACTIV-3 – Therapeutics for inpatients with COVID-19 (TICO) Study Group. Tixagevimab-cilgavimab for treatment of patients hospitalised with COVID-19: A randomised, double-blind, phase 3 trial. Lancet Respir Med. 2022;10(10):972-984. doi:10.1016/S2213-2600(22)00215-6; Montgomery H, Hobbs FDR, Padilla F, Arbetter D, Templeton A, Seegobin S, et al.; TACKLE study group. Efficacy and safety of intramuscular administration of tixagevimab-cilgavimab for early outpatient treatment of COVID-19 (TACKLE): A phase 3, randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2022;10(10):985-996. doi:10.1016/S2213-2600(22)00180-1; Levin MJ, Ustianowski A, De Wit S, Launay O, Avila M, Templeton A, et al.; PROVENT Study Group. Intramuscular AZD7442 (tixagevimab-cilgavimab) for prevention of COVID-19. N Engl J Med. 2022;386(23):2188-2200. doi:10.1056/NEJMoa2116620; Alhumaid S, Al Mutair A, Alali J, Al Dossary N, Albattat SH, Al HajjiMohammed SM, 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; National Center for Advancing Translational Sciences. Evusheld: Tixagevimab (tixagevimab) and cilgavimab (cilgavimab) mAbs for SARS-CoV-2 antiviral resistance information (version 5). URL: https://opendata.ncats.nih.gov/variant/datasets?id=107 (Accessed: 24th September 2021).; Dejnirattisai W, Zhou D, Supasa P, Liu C, Mentzer AJ, Ginn HM, et al. Antibody evasion by the P.1 strain of SARS-CoV-2. Cell. 2021;184(11):2939-2954.e9. doi:10.1016/j.cell.2021.03.055; Chen RE, Zhang X, Case JB, Winkler ES, Liu Y, VanBlargan LA, et al. Resistance of SARS-CoV-2 variants to neutralization by monoclonal and serum-derived polyclonal antibodies. Nat Med. 2021;27(4):717-726. doi:10.1038/s41591-021-01294-w; Liu C, Ginn HM, Dejnirattisai W, Supasa P, Wang B, Tuekprakhon A, et al. Reduced neutralization of SARS-CoV-2 B.1.617 by vaccine and convalescent serum. Cell. 2021;184(16):4220-4236. e13. doi:10.1016/j.cell.2021.06.020; Bruel T, Hadjadj J, Maes P, Planas D, Seve A, Staropoli I, et al. Serum neutralization of SARS-CoV-2 Omicron sublineages BA.1 and BA.2 in patients receiving monoclonal antibodies. Nat Med. 2022;28(6):1297-1302. doi:10.1038/s41591-022-01792-5; VanBlargan LA, Errico JM, Halfmann PJ, Zost SJ, Crowe JE Jr, Purcell LA, et al. An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by therapeutic monoclonal antibodies. Nat Med. 2022;28(3):490-495. doi:10.1038/s41591-021-01678-y; Case JB, Mackin S, Errico JM, Chong Z, Madden EA, Whitener B, et al. Resilience of S309 and AZD7442 monoclonal antibody treatments against infection by SARS-CoV-2 Omicron lineage strains. Nat Commun. 2022;13(1):3824. doi:10.1038/s41467-022-31615-7; Cao Y, Yisimayi A, Jian F, Song W, Xiao T, Wang L, et al. BA.2.12.1, BA.4 and BA.5 escape antibodies elicited by Omicron infection. Nature. 2022;608(7923):593-602. doi:10.1038/s41586-022-04980-y; Tuekprakhon A, Huo J, Nutalai R, Dijokaite-Guraliuc A, Zhou D, Ginn HM, Selvaraj M, et al. Further antibody escape by Omicron BA.4 and BA.5 from vaccine and BA.1 serum. bioRxiv. 2022;05.21.492554. doi:10.1101/2022.05.21.492554; Fact sheet for healthcare providers. Emergency use authorization (EUA) of EVUSHELD™ (tixagevimab co-packaged with cilgavimab). 2022. URL: https://www.fda.gov/media/154702/download (Accessed: 26th January 2023).; Young-Xu Y, Epstein L, Marconi VC, Davey V, Zwain G, Smith J, et al. Tixagevimab/cilgavimab for prevention of COVID-19 during the Omicron surge: Retrospective analysis of national VA electronic data. medRxiv. 2022;05.28.22275716. doi:10.1101/2022.05.28.22275716; Al Jurdi A, Morena L, Cote M, Bethea E, Azzi J, Riella LV. Tixagevimab/cilgavimab pre-exposure prophylaxis is associated with lower breakthrough infection risk in vaccinated solid organ transplant recipients during the omicron wave. Am J Transplant. 2022;22(12):3130-3136. doi:10.1111/ajt.17128; Hodcroft EB. Overview of variants in countries. 2022. URL: https://covariants.org/per-country (Accessed: 31st March 2023).; Jian F, Yu Y, Song W, Yisimayi A, Yu L et al. Further humoral immunity evasion of emerging SARS-CoV-2 BA.4 and BA.5 subvariants. Lancet Infect Dis. 2022;22(11):1535-1537. doi:10.1016/S1473-3099(22)00642-9; Aqeel F, Geetha D. Tixagevimab and cilgavimab (Evusheld) in rituximab-treated antineutrophil cytoplasmic antibody vasculitis patients. Kidney Int Rep. 2022;7(11):2537-2538. doi:10.1016/j.ekir.2022.08.019; Ocon AJ, Mustafa SS. Real-world experience of tixagevimab and cilgavimab (Evusheld) in rheumatologic patients on rituximab. J Clin Rheumatol. 2022;29(2):109-111. doi:10.1097/RHU.0000000000001907; Nguyen Y, Flahault A, Chavarot N, Melenotte C, Cheminant M, Deschamps P, et al.; AP-HP-Centre Monoclonal Antibodies Working Group. Pre-exposure prophylaxis with tixagevimab and cilgavimab (Evusheld) for COVID-19 among 1112 severely immunocompromised patients. Clin Microbiol Infect. 2022;28(12):1654.e1-1654.e4. doi:10.1016/j.cmi.2022.07.015; Calabrese C, Kirchner E, Villa-Forte A, Hajj-Ali RA, Moss BP, Fernandez JP, et al. Early experience with tixagevimab/cilgavimab pre-exposure prophylaxis in patients with immunemediated 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; Kertes J, Shapiro Ben David S, Engel-Zohar N, Rosen K, Hemo B, Kantor A, et al. Association between AZD7442 (tixagevimab-cilgavimab) administration and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, hospitalization, and mortality. Clin Infect Dis. 2023;76(3):e126-e132. doi:10.1093/cid/ciac625; Бекетова ТВ, Бабак ВВ, Супрун МД. Течение и исходы COVID-19 у пациентов с АНЦА-ассоциированными системными васкулитами, получающих лечение генно-инженерными биологическими препаратами (ритуксимаб, меполизумаб): итоги первых 8 месяцев пандемии. Научно-практическая ревматология. 2021;59(1):37-46. doi:10.47360/1995-4484-2021-37-46