Monoclonal antibodies significantly reduced risk for COVID-19 hospitalization, death
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Key takeaways:
- Treatment with monoclonal antibodies lowered the risk for COVID-19 hospitalization and death by 39%.
- The FDA withdrew EUAs for all five mAbs because they are not effective against circulating SARS-CoV-2 variants.
Treatment with a monoclonal antibody within 2 days of a COVID-19 diagnosis reduced the risk for hospitalization or death by almost 40%, according to a study that assessed patient outcomes over a nearly 2-year period.
Five monoclonal antibodies (mAbs) targeting SARS-CoV-2 were authorized by the FDA for COVID-19, but all five emergency use authorizations (EUAs) have since been withdrawn because of their ineffectiveness against circulating variants.
Although there are currently no mAbs authorized for COVID-19, Kevin E. Kip, PhD, FIDSA, and colleagues sought to determine whether their use translated to real-world health benefits.
Kip noted that the antiviral therapy Paxlovid, which remains in use and is up for FDA approval for mild-to-moderate COVID-19 in high-risk adults, is more broadly effective against SARS-CoV-2 variants.
“While future evolution of both [SARS-CoV-2] and the development and use of monoclonal antibodies is uncertain, the trend seems to be away from future development/approval of monoclonal antibodies, presumably in large part because these therapies are highly specific to targeting the spike protein of variants/subvariants, and the spike protein has a high propensity for mutation,” Kip, who is vice president of clinical analytics at the University of Pittsburgh Medical Center, told Healio.
Kip and colleagues analyzed University of Pittsburgh Medical Center electronic health records of 2,571 patients aged 12 years or older treated with monoclonal antibodies and 5,135 matching patients who did not receive an mAb between Dec. 8, 2020, and Aug. 31, 2022.
They classified patients as treated if they received “early” treatment with monoclonal antibodies or nontreated if they either never received monoclonal antibodies or received them within 3 to 10 days of diagnosis. For the analysis, the researchers also varied the primary 2-day early treatment period to 1 and 3 days.
Among nontreated patients during the 1-, 2- and 3-day grace periods, 10.3%, 6.1% and 3.2% of patients received monoclonal antibodies after the grace periods.
Over the course of the study period, depending on how many and which mAbs were available, treated patients received either IV bamlanivimab, IV bamlanivimab-etesevimab, IV or subcutaneous casirivimab-imdevimab, IV sotrovimab, or IV bebtelovimab, according to the study.
Across the full study period, Kip and colleagues reported that treatment with mAbs within 2 days of SARS-CoV-2 infection was associated with an estimated 39% lower risk for hospitalization or death at 28 days (RR = 0.61; 95% CI, 0.5-0.74), with risk reductions for the 1- and 3-day subgroups of 41% and 51%.
Specifically, the overall risk for hospitalization or death at 28 days for treated patients was 4.6%, whereas the overall risk for hospitalization among the nontreated group was 7.6%.
The effect of mAb treatment “was especially evident” in an 86% lower risk for death among the treatment group (RR = 0.14; 95% CI, 0.07-0.26), Kip and colleagues reported.
“When approved for use in specific patient populations and prevalent COVID-19 variants/subvariants, monoclonal antibodies are highly effective in reducing future risk of death or hospitalization,” Kip said.
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