Neutralizing anti-spike monoclonal antibodies for COVID-19 in vulnerable populations: lessons learned and future directions

References

• Razonable RR, Aloia NCE, Anderson RJ, et al. A framework for outpatient infusion of antispike monoclonal antibodies to high-risk patients with mild-to-moderate coronavirus disease-19: the mayo clinic model. Mayo Clin Proc. 2021;96(5):1250–1261. doi: 10.1016/j.mayocp.2021.03.010
   PubMed Web of Science ®Google Scholar
• Razonable RR, Pennington KM, Meehan AM, et al. A collaborative multidisciplinary approach to the management of coronavirus disease 2019 in the hospital setting. Mayo Clin Proc. 2020;95(7):1467–1481. doi: 10.1016/j.mayocp.2020.05.010
   PubMed Web of Science ®Google Scholar
• Razonable RR, Carmona EM, Vergidis P, et al. Clinical guidance and the delivery of care for patients with coronavirus disease 2019. Mayo Clin Proc. 2020;95:S23–S25. doi: 10.1016/j.mayocp.2020.05.037
   PubMed Web of Science ®Google Scholar
• Chen P, Nirula A, Heller B, et al. SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with covid-19. N Engl J Med. 2020;384(3):229–237. doi: 10.1056/NEJMoa2029849
   PubMed Web of Science ®Google Scholar
• Weinreich DM, Sivapalasingam S, Norton T, et al. REGN-COV2, a neutralizing antibody cocktail, in outpatients with covid-19. N Engl J Med. 2020;384(3):238–251. doi: 10.1056/NEJMoa2035002
   PubMed Web of Science ®Google Scholar
• Gupta A, Gonzalez-Rojas Y, Juarez E, et al. Early treatment for covid-19 with SARS-CoV-2 neutralizing antibody sotrovimab. N Engl J Med. 2021;385:1941–1950.
   PubMed Web of Science ®Google Scholar
• Gupta A, Gonzalez-Rojas Y, Juarez E, et al. Effect of sotrovimab on hospitalization or death among high-risk patients with mild to moderate COVID-19: a randomized clinical trial. JAMA. 2022;327(13):1236. doi: 10.1001/jama.2022.2832
   PubMed Web of Science ®Google Scholar
• Joyner MJ, Carter RE, Senefeld JW, et al. Convalescent plasma antibody levels and the risk of death from covid-19. N Engl J Med. 2021;384:1015–1027. doi: 10.1056/NEJMoa2031893
   PubMed Web of Science ®Google Scholar
• Dougan M, Nirula A, Azizad M, et al. Bamlanivimab plus etesevimab in mild or moderate covid-19. N Engl J Med. 2021;385:1382–1392. doi: 10.1056/NEJMoa2102685
   PubMed Web of Science ®Google Scholar
• Weinreich DM, Sivapalasingam S, Norton T, et al. REGEN-COV antibody combination and outcomes in outpatients with covid-19. N Engl J Med. 2021;385:e81.
   PubMed Web of Science ®Google Scholar
• Levin MJ, Ustianowski A, De Wit S, et al. Intramuscular AZD7442 (Tixagevimab-cilgavimab) for prevention of covid-19. N Engl J Med. 2022;386:2188–2200. doi: 10.1056/NEJMoa2116620
   PubMed Web of Science ®Google Scholar
• Cohen MS, Nirula A, Mulligan MJ, et al. Effect of bamlanivimab vs placebo on incidence of COVID-19 among residents and staff of skilled nursing and assisted living facilities: a randomized clinical trial. JAMA. 2021;326:46–55. doi: 10.1001/jama.2021.8828
   PubMed Web of Science ®Google Scholar
• O’Brien MP, Forleo-Neto E, Musser BJ, et al. Subcutaneous REGEN-COV antibody combination to prevent covid-19. N Engl J Med. 2021;385:1184–1195. doi: 10.1056/NEJMoa2109682
   PubMed Web of Science ®Google Scholar
• Lundgren JD, Grund B, Barkauskas CE, et al. A neutralizing monoclonal antibody for hospitalized patients with covid-19. N Engl J Med. 2021;384:905–914.
   PubMed Web of Science ®Google Scholar
• Ganesh R, Pawlowski CF, O’Horo JC, et al. Intravenous bamlanivimab use associates with reduced hospitalization in high-risk patients with mild to moderate COVID-19. J Clin Investig. 2021;131(19). doi: 10.1172/JCI151697
   PubMed Web of Science ®Google Scholar
• Kip KE, McCreary EK, Collins K, et al. Evolving real-world effectiveness of monoclonal antibodies for treatment of COVID-19: a cohort study. Ann Intern Med. 2023;176(4):496–504. doi: 10.7326/M22-1286
   PubMed Web of Science ®Google Scholar
• Bariola JR, McCreary EK, Wadas RJ, et al. Impact of bamlanivimab monoclonal antibody treatment on hospitalization and mortality among nonhospitalized adults with severe acute respiratory syndrome coronavirus 2 infection. Open Forum Infect Dis. 2021;8(7):ofab254. DOI:10.1093/ofid/ofab254
   PubMed Web of Science ®Google Scholar
• Anonymous. Bamlanivimab and etesevimab for post-exposure prophylaxis of COVID-19. Med Lett Drugs Ther. 2021;63:163–164.
   PubMed Web of Science ®Google Scholar
• O’Horo J, Challener DW, Anderson RJ, et al. Rates of severe outcomes after bamlanivimab-etesevimab and casirivimab-imdevimab treatment of high-risk patients with mild to moderate coronavirus disease 2019. Mayo Clin Proc. 2022;97(5):943–950. doi: 10.1016/j.mayocp.2022.02.009
   PubMed Web of Science ®Google Scholar
• O’Horo JC, Challener D, Speicher LL, et al. Effectiveness of monoclonal antibodies in preventing severe COVID-19 with emergence of the delta variant. Mayo Clin Proc. 2022;97:327–332. doi: 10.1016/j.mayocp.2021.12.002
   PubMed Web of Science ®Google Scholar
• Razonable RR, O’Horo JC, Challener DW, et al. Curbing the delta surge: clinical outcomes after treatment with bamlanivimab-etesevimab, casirivimab-imdevimab, or sotrovimab for mild to moderate coronavirus disease 2019. Mayo Clin Proc. 2022;97(9):1641–1648. doi: 10.1016/j.mayocp.2022.06.015
   PubMed Web of Science ®Google Scholar
• Johnson PW, Kunze KL, Senefeld JW, et al. Association of neutralizing antispike monoclonal antibody treatment with coronavirus disease 2019 hospitalization and assessment of the monoclonal antibody screening score. Mayo Clin Proc Innov Qual Outcomes. 2023;7(2):109–121. doi: 10.1016/j.mayocpiqo.2022.12.007
   PubMedGoogle Scholar
• Razonable RR, Pawlowski C, O’Horo JC, et al. Casirivimab-Imdevimab treatment is associated with reduced rates of hospitalization among high-risk patients with mild to moderate coronavirus disease-19. EClinicalMedicine. 2021;40:101102. doi: 10.1016/j.eclinm.2021.101102
   PubMedGoogle Scholar
• Herman GA, O’Brien MP, Forleo-Neto E, et al. Efficacy and safety of a single dose of casirivimab and imdevimab for the prevention of COVID-19 over an 8-month period: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2022;22:1444–1454. doi: 10.1016/S1473-3099(22)00416-9
   PubMedGoogle Scholar
• Razonable RR, Tulledge-Scheitel SM, Hanson SN, et al. Real-world clinical outcomes of bebtelovimab and sotrovimab treatment of high-risk persons with coronavirus disease 2019 during the Omicron Epoch. Open Forum Infect Dis. 2022;9(10):ofac411. doi: 10.1093/ofid/ofac411
   PubMed Web of Science ®Google Scholar
• Dougan M, Azizad M, Chen P. Bebtelovimab, alone or together with bamlanivimab and etesevimab, as a broadly neutralizing monoclonal antibody treatment for mild to moderate, ambulatory COVID-19. MedRxIV. 2022. medRxiv:2022.03.10.22272100.
   Google Scholar
• Yetmar ZA, Beam E, O’Horo JC, et al. Outcomes of bebtelovimab and sotrovimab treatment of solid organ transplant recipients with mild-to-moderate coronavirus disease 2019 during the Omicron epoch. Transpl Infect Dis. 2022;24(4):e13901. doi: 10.1111/tid.13901
   PubMed Web of Science ®Google Scholar
• McCreary EK, Kip KE, Collins K, et al. Evaluation of bebtelovimab for treatment of covid-19 during the SARS-CoV-2 Omicron variant era. Open Forum Infect Dis. 2022;9(10):ofac517. doi: 10.1093/ofid/ofac517
   PubMed Web of Science ®Google Scholar
• Levin MJ, Ustianowski A, Thomas S, et al. AZD7442 (Tixagevimab/cilgavimab) for post-exposure prophylaxis of symptomatic coronavirus disease 2019. Clin Infect Dis. 2023;76:1247–1256. doi: 10.1093/cid/ciac899
   PubMed Web of Science ®Google Scholar
• Al Jurdi A, Morena L, Cote M, et al. 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
   PubMed Web of Science ®Google Scholar
• Ordaya EE, Higgins EM, Vergidis P, et al. Real-world experience of tixagevimab-cilgavimab pre-exposure prophylaxis in orthotopic heart transplant recipients. Transpl Infect Dis. 2023. doi: 10.1111/tid.14040
   Web of Science ®Google Scholar
• Ordaya EE, Beam E, Yao JD, et al. Characterization of early-onset severe acute respiratory syndrome coronavirus 2 infection in immunocompromised patients who received tixagevimab-cilgavimab prophylaxis. Open Forum Infect Dis. 2022;9(7):ofac283. doi: 10.1093/ofid/ofac283
   PubMed Web of Science ®Google Scholar
• Ordaya EE, Vergidis P, Razonable RR, et al. Genotypic and predicted phenotypic analysis of SARS-COV-2 Omicron subvariants in immunocompromised patients with COVID-19 following tixagevimab-cilgavimab prophylaxis. J Clin Virol. 2023;160:105382. doi: 10.1016/j.jcv.2023.105382
   PubMed Web of Science ®Google Scholar
• Razonable RR, Pawlowski C, O’Horo JC, et al. Casirivimab–Imdevimab treatment is associated with reduced rates of hospitalization among high-risk patients with mild to moderate coronavirus disease-19. EClinicalMedicine. 2021;40:101102. doi: 10.1016/j.eclinm.2021.101102
   PubMedGoogle Scholar
• Webb BJ, Buckel W, Vento T, et al. Real-world effectiveness and tolerability of monoclonal antibody therapy for ambulatory patients with early COVID-19. Open Forum Infect Dis. 2021;8(7):ofab331. doi: 10.1093/ofid/ofab331
   PubMed Web of Science ®Google Scholar
• Razonable RR, Ganesh R, Bierle DM. Clinical prioritization of antispike monoclonal antibody treatment of mild to moderate COVID-19. Mayo Clin Proc. 2022;97(1):26–30. doi: 10.1016/j.mayocp.2021.11.017
   PubMed Web of Science ®Google Scholar
• Bierle DM, Ganesh R, Tulledge-Scheitel S, et al. Monoclonal antibody treatment of breakthrough COVID-19 in fully vaccinated individuals with high-risk comorbidities. J Infect Dis. 2021. doi: 10.1093/infdis/jiab570
   PubMed Web of Science ®Google Scholar
• Gottlieb RL, Nirula A, Chen P, et al. Effect of bamlanivimab as monotherapy or in combination with etesevimab on viral load in patients with mild to moderate COVID-19: a randomized clinical trial. JAMA. 2021;325(7):632–644. doi: 10.1001/jama.2021.0202
   PubMed Web of Science ®Google Scholar
• Yetmar ZA, Khodadadi RB, Seville MT, et al. Outcomes of B-Cell-depleted patients with coronavirus disease 2019 treated with antispike monoclonal antibodies. Open Forum Infect Dis. 2022;9(7):ofac204. doi: 10.1093/ofid/ofac204
   PubMed Web of Science ®Google Scholar
• Yetmar Z, Beam E, O’Horo JC, et al. Monoclonal antibody therapy for solid organ transplant recipients. Am J Transplant. 2021;8(6). doi: 10.1093/ofid/ofab255
   Google Scholar
• Yetmar ZA, Beam E, O’Horo JC, et al. Monoclonal antibody therapy for COVID-19 in solid organ transplant recipients. Open Forum Infect Dis. 2021;8(6):ofab255. doi: 10.1093/ofid/ofab255
   PubMed Web of Science ®Google Scholar
• Hammond J, Leister-Tebbe H, Gardner A, et al. Oral nirmatrelvir for high-risk, nonhospitalized adults with covid-19. N Engl J Med. 2022;386:1397–1408. doi: 10.1056/NEJMoa2118542
   PubMed Web of Science ®Google Scholar
• Beigel JH, Tomashek KM, Dodd LE, et al. Remdesivir for the treatment of covid-19 - Final Report. N Engl J Med. 2020;383:1813–1826. doi: 10.1056/NEJMoa2007764
   PubMed Web of Science ®Google Scholar
• Gottlieb RL, Vaca CE, Paredes R, et al. Early remdesivir to prevent progression to severe covid-19 in outpatients. N Engl J Med. 2022;386:305–315. doi: 10.1056/NEJMoa2116846
   PubMed Web of Science ®Google Scholar
• Ripoll JG, Gorman EK, Juskewitch JE, et al. Vaccine-boosted convalescent plasma therapy for patients with immunosuppression and COVID-19. Blood Adv. 2022;6:5951–5955. doi: 10.1182/bloodadvances.2022008932
   PubMed Web of Science ®Google Scholar
• Totschnig D, Doberer D, Haberl R, et al. Treatment of persistent COVID-19 in two B-cell-depleted patients with the monoclonal antibody sotrovimab. IDCases. 2022;29:e01528. doi: 10.1016/j.idcr.2022.e01528
   PubMed Web of Science ®Google Scholar
• Bloch EM, Focosi D, Shoham S, et al. Guidance on the use of convalescent plasma to treat immunocompromised patients with COVID-19. Clin Infect Dis. 2023;76(11):2018–2024. doi: 10.1093/cid/ciad066
   PubMedGoogle Scholar
• Harpaz R, Dahl RM, Dooling KL. Prevalence of immunosuppression among US adults, 2013. JAMA. 2016;316(23):2547–2548. doi: 10.1001/jama.2016.16477
   PubMed Web of Science ®Google Scholar
• Ambrose N, Amin A, Anderson B, et al. Neutralizing monoclonal antibody use and COVID-19 infection outcomes. JAMA Netw Open. 2023;6(4):e239694. doi: 10.1001/jamanetworkopen.2023.9694
   PubMedGoogle Scholar
• Patel NJ, D’Silva KM, Hsu TY, et al. Coronavirus disease 2019 outcomes among recipients of anti-CD20 monoclonal antibodies for immune-mediated diseases: a comparative cohort study. ACR Open Rheumatol. 2022;4:238–246. doi: 10.1002/acr2.11386
   PubMedGoogle Scholar
• Mikulska M, Sepulcri C, Dentone C, et al. Triple combination therapy with two antivirals and monoclonal antibodies for persistent or relapsed SARS-CoV-2 infection in immunocompromised patients. Clin Infect Dis. 2023. doi: 10.1093/cid/ciad181
   Web of Science ®Google Scholar
• Sullivan DJ, Gebo KA, Shoham S, et al. Early outpatient treatment for COVID-19 with convalescent plasma. N Engl J Med. 2022;386(18):1700–1711. doi: 10.1056/NEJMoa2119657
   PubMed Web of Science ®Google Scholar
• Yetmar ZA, O’Horo JC, Seville MT, et al. Outcomes of solid organ transplant recipients treated with antispike monoclonal antibodies for coronavirus disease 2019 across variant epochs: impact of comorbidities and vaccination. Transplantation. 2022;106(11):e507–e509. doi: 10.1097/TP.0000000000004325
   PubMed Web of Science ®Google Scholar
• Yetmar ZA, Razonable RR. No patient left behind: a multilayered approach to mitigate COVID-19 in transplant recipients. Transpl Infect Dis. 2023;25(1):e13956. doi: 10.1111/tid.13956
   PubMed Web of Science ®Google Scholar
• Scherer EM, Babiker A, Adelman MW, et al. SARS-CoV-2 evolution and immune escape in immunocompromised patients. N Engl J Med. 2022;386(25):2436–2438. doi: 10.1056/NEJMc2202861
   PubMed Web of Science ®Google Scholar