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

DOI record: { "DOI": "10.1101/2022.02.28.22270796", "URL": "http://dx.doi.org/10.1101/2022.02.28.22270796", "abstract": "<jats:title>Abstract</jats:title><jats:p><jats:bold>Background</jats:bold></jats:p><jats:p>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.</jats:p><jats:p><jats:bold>Methods</jats:bold></jats:p><jats:p>Data from Optum<jats:sup>®</jats:sup> Clinformatics<jats:sup>®</jats:sup> 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).</jats:p><jats:p><jats:bold>Results</jats:bold></jats:p><jats:p>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 high-risk patients; earlier intervention was associated with improved outcomes.</jats:p><jats:p><jats:bold>Conclusions</jats:bold></jats:p><jats:p>This real-world study further supports randomized clinical trial findings that treatment with CAS+IMD reduces the risk of hospitalization and mortality in patients infected with susceptible variants.</jats:p>", "accepted": { "date-parts": [ [ 2022, 2, 28 ] ] }, "author": [ { "ORCID": "http://orcid.org/0000-0002-8766-7769", "affiliation": [], "authenticated-orcid": false, "family": "Wei", "given": "Wenhui", "sequence": "first" }, { "affiliation": [], "family": "Murdock", "given": "Dana", "sequence": "additional" }, { "affiliation": [], "family": "Jalbert", "given": "Jessica J.", "sequence": "additional" }, { "affiliation": [], "family": "Mastey", "given": "Vera", "sequence": "additional" }, { "affiliation": [], "family": "Sanchez", "given": "Robert J.", "sequence": "additional" }, { "affiliation": [], "family": "Hirshberg", "given": "Boaz", "sequence": "additional" }, { "affiliation": [], "family": "Weinreich", "given": "David M.", "sequence": "additional" }, { "affiliation": [], "family": "Hussein", "given": "Mohamed", "sequence": "additional" } ], "container-title": [], "content-domain": { "crossmark-restriction": false, "domain": [] }, "created": { "date-parts": [ [ 2022, 3, 1 ] ], "date-time": "2022-03-01T08:15:14Z", "timestamp": 1646122514000 }, "deposited": { "date-parts": [ [ 2022, 3, 2 ] ], "date-time": "2022-03-02T21:40:24Z", "timestamp": 1646257224000 }, "group-title": "Infectious Diseases (except HIV/AIDS)", "indexed": { "date-parts": [ [ 2022, 3, 4 ] ], "date-time": "2022-03-04T02:11:35Z", "timestamp": 1646359895326 }, "institution": [ { "name": "medRxiv" } ], "is-referenced-by-count": 0, "issued": { "date-parts": [ [ 2022, 2, 28 ] ] }, "link": [ { "URL": "https://syndication.highwire.org/content/doi/10.1101/2022.02.28.22270796", "content-type": "unspecified", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "246", "original-title": [], "posted": { "date-parts": [ [ 2022, 2, 28 ] ] }, "prefix": "10.1101", "published": { "date-parts": [ [ 2022, 2, 28 ] ] }, "publisher": "Cold Spring Harbor Laboratory", "reference": [ { "DOI": "10.1056/nejmoa2108163", "doi-asserted-by": "publisher", "key": "2022030213400654000_2022.02.28.22270796v1.1" }, { "key": "2022030213400654000_2022.02.28.22270796v1.2", "unstructured": "U.S. Food & Drug Administration. 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