Real-world effectiveness of casirivimab and imdevimab among patients diagnosed with COVID-19 in the ambulatory setting: a retrospective cohort study using a large claims database
Dr Mohamed Hussein, Wenhui Wei, Vera Mastey, Robert J Sanchez, Degang Wang, Dana J Murdock, Boaz Hirshberg, David M Weinreich, Jessica J Jalbert
BMJ Open, doi:10.1136/bmjopen-2022-064953
Objective To assess the real-world effectiveness of casirivimab and imdevimab (CAS+IMD) versus no COVID-19 antibody treatment among patients diagnosed with COVID-19 in the ambulatory setting, including patients diagnosed during the Delta-dominant period prior to Omicron emergence. Design Retrospective cohort study. Setting Komodo Health closed claims database. Participants 13 273 128 patients diagnosed with COVID-19 (December 2020 through September 2021) were treated with CAS+IMD or untreated but treatment eligible under the Emergency Use Authorization (EUA). Each treated patient was exact and propensity score matched without replacement to up to five untreated EUA-eligible patients.
Interventions CAS+IMD. Primary and secondary outcome measures Composite endpoint of 30-day all-cause mortality or COVID-19related hospitalisation. Kaplan-Meier estimators were used to calculate outcome risks overall and across subgroups: age, COVID-19 vaccination status, immunocompromised status, and timing of diagnosis (December 2020 to June 2021, and July to September 2021). Cox proportional hazards models were used to estimate adjusted HRs (aHRs) and 95% CIs. Results Among 75 159 CAS+IMD-treated and 1 670 338 EUA-eligible untreated patients, 73 759 treated patients were matched to 310 688 untreated patients; matched patients were ~50 years, ~60% were women and generally well balanced across risk factors. The 30-day risk of the composite outcome was 2.1% and 5.2% in the CAS+IMD-treated and CAS+IMD-untreated patients, respectively; equivalent to a 60% lower risk (aHR 0.40; 95% CI, 0.38 to 0.42). The effect of CAS+IMD was consistent across subgroups, including those who received a COVID-19 vaccine (aHR 0.48, 95% CI, 0.41 to 0.56), and those diagnosed during the Delta-dominant period (aHR 0.40, 95% CI, 0.38 to 0.42). Conclusions The real-world effectiveness of CAS+IMD is consistent with the efficacy for reducing all-cause mortality or COVID-19-related hospitalisation reported in clinical trials. Effectiveness is maintained across patient subgroups, including those prone to breakthrough infections, and was effective against susceptible variants including Delta.
Ethics approval This study was conducted as secondary research using deidentified data licensed from a third party, Komodo, in compliance with 45 CFR 164.514(a)-(c). The data had identifying patient information removed and were coded in such a way that they could not be linked back to subjects from whom they were originally collected prior to the authors gaining access. This research did not require institutional review board or ethics review, as analyses of these data do not meet the definition of 'research involving human subjects' as defined within 45 CFR 46.102(f), which stipulates human subjects as living individuals about whom an investigator obtains identifiable private information for research purposes. Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as online supplemental information. All data generated or analysed during this study are included in this published article. Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the..
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doi:10.1101/2021.12.07.21267432v2DOI record:
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