TY - JOUR
T1 - Real-world Clinical Outcomes of Bebtelovimab and Sotrovimab Treatment of High-risk Persons With Coronavirus Disease 2019 During the Omicron Epoch
AU - Razonable, Raymund R.
AU - Tulledge-Scheitel, Sidna M.
AU - Hanson, Sara N.
AU - Arndt, Richard F.
AU - Speicher, Leigh L.
AU - Seville, Teresa A.
AU - Larsen, Jennifer J.
AU - Ganesh, Ravindra
AU - O'horo, John C.
N1 - Funding Information:
This research was supported by an intramural research grant from the Mayo Clinic (funds to R.R.R.).
Funding Information:
Potential conflicts of interest. R.R.R. received grants (funds to the institution) from Gilead, Roche, and Regeneron. R.R.R. is a member of the DSMB of Novartis and has served on advisory boards for Merck, Glaxo-Smith-Kline, and Roche. R.R.R. is a member of the Board of Directors of the American Society of Transplantation. J.C.O. is supported by grants from nFerence and is a paid consultant for Elsevier, Inc., and Bates College. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
Publisher Copyright:
© 2022 The Author(s). Published by Oxford University Press on behalf of Infectious Diseases Society of America.
PY - 2022/10/1
Y1 - 2022/10/1
N2 - Background: Antispike monoclonal antibodies are recommended for early treatment of high-risk persons with mild to moderate coronavirus disease 2019 (COVID-19). However, clinical outcomes of their use during the severe acute respiratory syndrome coronavirus 2 Omicron wave are limited. Methods: This is a descriptive retrospective study of high-risk adult patients who received treatment with sotrovimab (January 1-March 20, 2022) or bebtelovimab (March 21-April 30, 2022). The primary outcome was the proportion of patients who progressed to severe outcome within 30 days after receiving antispike-neutralizing monoclonal antibody infusion. Results: A total of 3872 high-risk patients (median age, 62.7 years; 41.1% male) with mild to moderate COVID-19 received sotrovimab (n = 2182) or bebtelovimab (n = 1690). Among sotrovimab-treated patients, the most common comorbidities were an immunosuppressed condition (46.7%), hypertension (38.2%), and diabetes (21.2%). The rates of severe outcome, intensive care unit (ICU) admission, and mortality were 2.2%, 1.0%, and 0.4%, respectively, after sotrovimab infusion. Among bebtelovimab-treated patients, the most common comorbidities were hypertension (42.7%), diabetes (17.1%), and an immunosuppressed condition (17.0%). The rates of severe disease, ICU admission, and mortality were 1.3%, 0.5%, and 0.2%, respectively, after bebtelovimab infusion. Older age, immunosuppressed status, and several comorbidities were associated with severe disease progression, while COVID-19 vaccination was associated with lower risk. No anaphylaxis was reported during monoclonal antibody infusion. Conclusions: This real-world analysis of a large cohort of high-risk patients demonstrates low rates of severe disease after treatment with sotrovimab during the era dominated by Omicron B.1.1.529 and after treatment with bebtelovimab during the era dominated by BA.2 and Omicron subvariants.
AB - Background: Antispike monoclonal antibodies are recommended for early treatment of high-risk persons with mild to moderate coronavirus disease 2019 (COVID-19). However, clinical outcomes of their use during the severe acute respiratory syndrome coronavirus 2 Omicron wave are limited. Methods: This is a descriptive retrospective study of high-risk adult patients who received treatment with sotrovimab (January 1-March 20, 2022) or bebtelovimab (March 21-April 30, 2022). The primary outcome was the proportion of patients who progressed to severe outcome within 30 days after receiving antispike-neutralizing monoclonal antibody infusion. Results: A total of 3872 high-risk patients (median age, 62.7 years; 41.1% male) with mild to moderate COVID-19 received sotrovimab (n = 2182) or bebtelovimab (n = 1690). Among sotrovimab-treated patients, the most common comorbidities were an immunosuppressed condition (46.7%), hypertension (38.2%), and diabetes (21.2%). The rates of severe outcome, intensive care unit (ICU) admission, and mortality were 2.2%, 1.0%, and 0.4%, respectively, after sotrovimab infusion. Among bebtelovimab-treated patients, the most common comorbidities were hypertension (42.7%), diabetes (17.1%), and an immunosuppressed condition (17.0%). The rates of severe disease, ICU admission, and mortality were 1.3%, 0.5%, and 0.2%, respectively, after bebtelovimab infusion. Older age, immunosuppressed status, and several comorbidities were associated with severe disease progression, while COVID-19 vaccination was associated with lower risk. No anaphylaxis was reported during monoclonal antibody infusion. Conclusions: This real-world analysis of a large cohort of high-risk patients demonstrates low rates of severe disease after treatment with sotrovimab during the era dominated by Omicron B.1.1.529 and after treatment with bebtelovimab during the era dominated by BA.2 and Omicron subvariants.
KW - COVID-19
KW - bebtelovimab
KW - hospitalization
KW - monoclonal antibodies
KW - sotrovimab
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U2 - 10.1093/ofid/ofac411
DO - 10.1093/ofid/ofac411
M3 - Article
AN - SCOPUS:85145100363
SN - 2328-8957
VL - 9
JO - Open Forum Infectious Diseases
JF - Open Forum Infectious Diseases
IS - 10
M1 - ofac411
ER -