Clinical efficacy of casirivimab and imdevimab in preventing COVID-19 in the Omicron BA.5 subvariant epidemic: a retrospective study
Mariko Ohtani, Takuya Yokoo, Taito Miyazaki, Hiroshi Yasuda, Eriko Nishikawa, Manabu Tomida, Mayumi Tsukada, Emi Sato, Shinobu Hirayama, Hinako Murakami, Sadako Yoshizawa, Takahiro Matsumoto, Kazuhiro Tateda
Journal of Pharmaceutical Health Care and Sciences, doi:10.1186/s40780-025-00501-x
Background The neutralizing monoclonal antibody combination of casirivimab and imdevimab (CAS + IMD) is the only therapy approved for preventing coronavirus disease 2019 following exposure to severe acute respiratory syndrome coronavirus 2. However, the efficacy of CAS + IMD against Omicron variants remains uncertain, with in vitro studies indicating reduced neutralizing activity. This study aimed to evaluate the clinical efficacy of CAS + IMD in preventing COVID-19 among uninfected hospitalized contacts of patients with COVID-19. Methods A retrospective chart review was conducted on 154 inpatients exposed to patients with COVID-19 between October and December 2022. Fifty-two uninfected participants who were unvaccinated or immunosuppressed and had risk factors for severe COVID-19 were included. The primary endpoint was the COVID-19 incidence rate. Statistical analyses included the chi-square test, Fisher's exact test, and Mann-Whitney U test, as appropriate. Factors associated with COVID-19 incidence (p < 0.05) in univariate analysis were included in the multivariate logistic regression. Statistical significance was set at p < 0.05.
Results Among the 52 participants, 14 and 38 were included in the CAS + IMD and non-CAS + IMD groups, respectively. The COVID-19 incidence rate was significantly lower in the CAS + IMD group than in the non-CAS + IMD group (14.3% vs. 52.6%, p = 0.013). Multivariate analysis identified CAS + IMD administration as significantly associated with reduced COVID-19 incidence (adjusted odds ratio [OR], 0.121; 95% confidence interval [CI], 0.020-0.710; p = 0.019), whereas long-term use of immunosuppressive therapy was associated with increased incidence (adjusted OR, 4.320; 95% CI,; p = 0.037). Conclusions CAS + IMD may be effective for post-exposure prophylaxis of COVID-19 during the Omicron BA.5 subvariant epidemic. However, prudent clinical use should consider the circulating variant profile. Further research is warranted to validate CAS + IMD's role in COVID-19 post-exposure prophylaxis.
Declarations Ethics approval and consent to participate This study adhered to the "Ethical Guidelines for Medical and Biological Research Involving Human Subjects" and was approved by the Ethics Committee of Toho University Omori Medical Center (approval number: M24037 22285). Patients were informed of their option to opt out, with details clearly outlined on the institutional website.
Consent for publication Not applicable.
Competing interests The authors declare no competing interests.
Publisher's note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
References
Carabelli, Peacock, Thorne, Harvey, Hughes et al., SARS-CoV-2 variant biology: immune escape, transmission and fitness, Nat Rev Microbiol
Deeks, Casirivimab/imdevimab: first approval, Drugs
Gershengorn, Patel, Ferreira, Das, Parekh et al., The clinical effectiveness of REGEN-COV in SARS-CoV-2 infection with Omicron versus Delta variants, PLoS ONE
Hagihara, Hayashi, Nakashima, Imai, Nakano et al., Clinical efficacy of imdevimab/casirivimab for persistent Omicron SARS-CoV-2 infection in patients with hematological malignancies, Intern Med
Herman, Brien, Forleo-Neto, Sarkar, Isa 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, placebocontrolled trial, Lancet Infect Dis
Imai, Ito, Kiso, Yamayoshi, Uraki et al., Efficacy of antiviral agents against Omicron subvariants BQ.1.1 and XBB, N Engl J Med
Kamegai, Iwamoto, Ishikane, Yamamoto, Horii et al., A novel protocol for de-isolating moderately and severely immunocompromised COVID-19 patients, Glob Health Med
O'brien, Forleo-Neto, Musser, Chan, Sarkar, Subcutaneous REGEN-COV antibody combination to prevent Covid-19, N Engl J Med
Planas, Bruel, Staropoli, Guivel-Benhassine, Porrot et al., Resistance of Omicron subvariants BA.2.75.2, BA.4.6, and BQ.1.1 to neutralizing antibodies, Nat Commun
Syed, Ciling, Taha, Chen, Khalid et al., Omicron mutations enhance infectivity and reduce antibody neutralization of SARS-CoV-2 virus-like particles, Proc Natl Acad Sci
Takashita, Kinoshita, Yamayoshi, Sakai-Tagawa, Fujisaki et al., Efficacy of antiviral agents against the SARS-CoV-2 Omicron subvariant BA.2, N Engl J Med
Takashita, Yamayoshi, Simon, Van Bakel, Sordillo et al., Efficacy of antibodies and antiviral drugs against Omicron BA.2.12.1, BA.4, and BA.5 subvariants, N Engl J Med
Walinjkar, Kumbhar, Shinde, Chaurasia, Real-world effect of casirivimab and imdevimab cocktail in patients infected with SARS-CoV-2 delta and omicron variants, J Infect Dev Ctries
Wang, Golubov, Oswald, Poon, Wei et al., Potential immunomodulatory effects of CAS+IMD monoclonal antibody cocktail in hospitalized patients with COVID-19, EBioMedicine
Wang, Iketani, Li, Liu, Guo et al., Alarming antibody evasion properties of rising SARS-CoV-2 BQ and XBB subvariants, Cell
Weinreich, Sivapalasingam, Norton, Ali, Gao et al., REGEN-COV antibody combination and outcomes in outpatients with Covid-19, N Engl J Med
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