Real-world Effectiveness of Casirivimab and Imdevimab in Patients With COVID-19 in the Ambulatory Setting: An Analysis of Two Large US National Claims Databases
Wei et al.,
Real-world Effectiveness of Casirivimab and Imdevimab in Patients With COVID-19 in the Ambulatory Setting: An..,
medRxiv, doi:10.1101/2022.02.28.22270796 (Preprint)
Retrospective 4,396 casirivimab/imdevimab patients in the USA, showing lower combined mortality/hospitalization (CDM database) and lower hospitalization (PMTX+ database) with treatment.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron [Liu, Sheward, Tatham, VanBlargan].
risk of death/hospitalization, 61.0% lower, HR 0.39, p < 0.001, treatment 23 of 1,116 (2.1%), control 27 of 5,291 (0.5%), Optum CDM, Cox proportional hazards.
|
risk of hospitalization, 61.0% lower, HR 0.39, p < 0.001, treatment 59 of 3,280 (1.8%), control 75 of 16,284 (0.5%), IQVIA PMTX+, Cox proportional hazards.
|
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
|
Wei et al., 28 Feb 2022, retrospective, database analysis, USA, preprint, 8 authors, study period December 2020 - June 2021.
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2022.02.28.22270796; this version posted February 28, 2022. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-NC-ND 4.0 International license .
Real-world Effectiveness of Casirivimab and Imdevimab in
Patients With COVID-19 in the Ambulatory Setting: An
Analysis of Two Large US National Claims Databases
Wenhui Wei, Dana Murdock, Jessica J. Jalbert, Vera Mastey, Robert J. Sanchez,
Boaz Hirshberg, David M. Weinreich, Mohamed Hussein
Regeneron Pharmaceuticals, Inc., Tarrytown, New York, NY
Corresponding to: Wenhui Wei, PhD, Email: wenhui.wei@regeneron.com
Alternate corresponding author: Mohamed Hussein, PhD,
Email: mohamed.hussein@regeneron.com
1
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
medRxiv preprint doi: https://doi.org/10.1101/2022.02.28.22270796; this version posted February 28, 2022. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-NC-ND 4.0 International license .
Abstract
Background: In a phase III clinical trial, casirivimab and imdevimab (CAS+IMD)
reduced the composite endpoint of COVID-19-related hospitalizations or all-cause
mortality in outpatients at risk of severe disease. This study assessed real-world
effectiveness of CAS+IMD.
Methods: Data from Optum® Clinformatics® Data Mart (CDM) and IQVIA Pharmetrics
Plus (PMTX+) were used to identify patients diagnosed with COVID-19 in ambulatory
settings between December 2020 and March 2021 (PMTX+) and June 2021 (CDM),
and either treated with CAS+IMD or untreated but treatment-eligible under Emergency
Use Authorization. CAS+IMD-treated patients were matched to untreated patients and
followed up to 30 days for the outcome of all-cause mortality or COVID-19-related
hospitalizations (CDM) and COVID-19-related hospitalizations (PMTX+). Kaplan-Meier
estimators were used to calculate outcome risks; Cox proportional-hazard models
estimated adjusted hazard ratios (aHR) with 95% confidence intervals (CI).
Results: For CDM, 1116 CAS+IMD-treated patients were matched to 5294 untreated
patients; for PMTX+, 3280 CAS+IMD-treated patients were matched to 16,284
untreated patients. The 30-day outcome risk was 2.1% and 5.3% in treated and
untreated cohorts, respectively (CDM), and the 30-day risk of COVID-19-related
hospitalization was 1.9% and 4.8%, respectively (PMTX+); translating to a 61% lower
adjusted outcome risk (CDM aHR 0.39 (95% CI 0.26–0.60; PMTX+ aHR 0.39 (95% CI
0.30–0.51). The benefit of treatment was maintained across multiple subgroups of highrisk patients; earlier intervention was associated with improved outcomes.
2
medRxiv preprint doi: https://doi.org/10.1101/2022.02.28.22270796; this version posted February 28, 2022. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-NC-ND 4.0 International license .
Conclusions: This real-world study further supports randomized clinical trial findings
that treatment with CAS+IMD reduces the risk of hospitalization and mortality in..
Please send us corrections, updates, or comments. Vaccines and
treatments are complementary. All practical, effective, and safe means should
be used based on risk/benefit analysis. No treatment, vaccine, or intervention
is 100% available and effective for all current and future variants. We do not
provide medical advice. Before taking any medication, consult a qualified
physician who can provide personalized advice and details of risks and
benefits based on your medical history and situation.
FLCCC and
WCH
provide treatment protocols.
Submit