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

{ 'institution': [{'name': 'medRxiv'}], 'indexed': {'date-parts': [[2022, 3, 4]], 'date-time': '2022-03-04T02:11:35Z', 'timestamp': 1646359895326}, 'posted': {'date-parts': [[2022, 2, 28]]}, 'group-title': 'Infectious Diseases (except HIV/AIDS)', 'reference-count': 25, 'publisher': 'Cold Spring Harbor Laboratory', 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'short-container-title': [], 'accepted': {'date-parts': [[2022, 2, 28]]}, '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>', 'DOI': '10.1101/2022.02.28.22270796', 'type': 'posted-content', 'created': {'date-parts': [[2022, 3, 1]], 'date-time': '2022-03-01T08:15:14Z', 'timestamp': 1646122514000}, 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': [ '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'], 'prefix': '10.1101', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-8766-7769', 'authenticated-orcid': False, 'given': 'Wenhui', 'family': 'Wei', 'sequence': 'first', 'affiliation': []}, {'given': 'Dana', 'family': 'Murdock', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jessica J.', 'family': 'Jalbert', 'sequence': 'additional', 'affiliation': []}, {'given': 'Vera', 'family': 'Mastey', 'sequence': 'additional', 'affiliation': []}, {'given': 'Robert J.', 'family': 'Sanchez', 'sequence': 'additional', 'affiliation': []}, {'given': 'Boaz', 'family': 'Hirshberg', 'sequence': 'additional', 'affiliation': []}, {'given': 'David M.', 'family': 'Weinreich', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mohamed', 'family': 'Hussein', 'sequence': 'additional', 'affiliation': []}], 'member': '246', 'reference': [ { 'key': '2022030213400654000_2022.02.28.22270796v1.1', 'doi-asserted-by': 'publisher', 'DOI': '10.1056/nejmoa2108163'}, { 'key': '2022030213400654000_2022.02.28.22270796v1.2', 'unstructured': 'U.S. Food & Drug Administration. 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