Real-World Effectiveness and Tolerability of Monoclonal Antibody Therapy for Ambulatory Patients with Early COVID-19

DOI record: { "DOI": "10.1093/ofid/ofab331", "ISSN": [ "2328-8957" ], "URL": "http://dx.doi.org/10.1093/ofid/ofab331", "abstract": "<jats:title>Abstract</jats:title>\n <jats:sec>\n <jats:title>Background</jats:title>\n <jats:p>Neutralizing monoclonal antibodies (MAbs) are a promising therapy for early coronavirus disease 2019 (COVID-19), but their effectiveness has not been confirmed in a real-world setting.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Methods</jats:title>\n <jats:p>In this quasi-experimental pre-/postimplementation study, we estimated the effectiveness of MAb treatment within 7 days of symptom onset in high-risk ambulatory adults with COVID-19. The primary outcome was a composite of emergency department visits or hospitalizations within 14 days of positive test. Secondary outcomes included adverse events and 14-day mortality. The average treatment effect in the treated for MAb therapy was estimated using inverse probability of treatment weighting and the impact of MAb implementation using propensity-weighted interrupted time series analysis.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Results</jats:title>\n <jats:p>Pre-implementation (July–November 2020), 7404 qualifying patients were identified. Postimplementation (December 2020–January 2021), 594 patients received MAb treatment and 5536 did not. The primary outcome occurred in 75 (12.6%) MAb recipients, 1018 (18.4%) contemporaneous controls, and 1525 (20.6%) historical controls. MAb treatment was associated with decreased likelihood of emergency care or hospitalization (odds ratio, 0.69; 95% CI, 0.60–0.79). After implementation, the weighted probability that a given patient would require an emergency department visit or hospitalization decreased significantly (0.7% per day; 95% CI, 0.03%–0.10%). Mortality was 0.2% (n = 1) in the MAb group compared with 1.0% (n = 71) and 1.0% (n = 57) in pre- and postimplementation controls, respectively. Adverse events occurred in 7 (1.2%); 2 (0.3%) were considered serious.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Conclusions</jats:title>\n <jats:p>MAb treatment of high-risk ambulatory patients with early COVID-19 was well tolerated and likely effective at preventing the need for subsequent emergency department or hospital care.</jats:p>\n </jats:sec>", "author": [ { "ORCID": "http://orcid.org/0000-0002-1799-3315", "affiliation": [ { "name": "Division of Infectious Diseases and Clinical Epidemiology, Intermountain Healthcare, Salt Lake City, Utah, USA" }, { "name": "Division of Infectious Diseases and Geographic Medicine, Stanford Medicine, Palo Alto, California, USA" } ], "authenticated-orcid": false, "family": "Webb", "given": "Brandon J", "sequence": "first" }, { "affiliation": [ { "name": "Pharmacy Services, Intermountain Healthcare, Salt Lake City, Utah, USA" } ], "family": "Buckel", "given": "Whitney", "sequence": "additional" }, { "affiliation": [ { "name": "Division of Infectious Diseases and Clinical Epidemiology, Intermountain Healthcare, Salt Lake City, Utah, USA" } ], "family": "Vento", "given": "Todd", "sequence": "additional" }, { "affiliation": [ { "name": "Enterprise Analytics, Intermountain Healthcare, Salt Lake City, Utah, USA" } ], "family": "Butler", "given": "Allison M", "sequence": "additional" }, { "affiliation": [ { "name": "Enterprise Analytics, Intermountain Healthcare, Salt Lake City, Utah, USA" } ], "family": "Grisel", "given": "Nancy", "sequence": "additional" }, { "affiliation": [ { "name": "Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center and University of Utah, Salt Lake City, Utah, USA" } ], "family": "Brown", "given": "Samuel M", "sequence": "additional" }, { "affiliation": [ { "name": "Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center and University of Utah, Salt Lake City, Utah, USA" } ], "family": "Peltan", "given": "Ithan D", "sequence": "additional" }, { "affiliation": [ { "name": "Division of Infectious Diseases, University of Utah School of Medicine, Salt Lake City, Utah, USA" } ], "family": "Spivak", "given": "Emily S", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Emergency Medicine, Intermountain Healthcare, Salt Lake City, Utah, USA" } ], "family": "Shah", "given": "Mark", "sequence": "additional" }, { "affiliation": [ { "name": "Urgent Care Service Line, Intermountain Healthcare, Salt Lake City, Utah, USA" } ], "family": "Sakata", "given": "Theadora", "sequence": "additional" }, { "affiliation": [ { "name": "Urgent Care Service Line, Intermountain Healthcare, Salt Lake City, Utah, USA" } ], "family": "Wallin", "given": "Anthony", "sequence": "additional" }, { "affiliation": [ { "name": "Division of Infectious Diseases and Clinical Epidemiology, Intermountain Healthcare, Salt Lake City, Utah, USA" }, { "name": "Division of Infectious Diseases and Geographic Medicine, Stanford Medicine, Palo Alto, California, USA" }, { "name": "Office of Patient Experience, Intermountain Healthcare, Salt Lake City, Utah, USA" } ], "family": "Stenehjem", "given": "Eddie", "sequence": "additional" }, { "affiliation": [ { "name": "Executive Leadership Team, Intermountain Healthcare, Salt Lake City, Utah, USA" } ], "family": "Poulsen", "given": "Greg", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Emergency Medicine, Intermountain Healthcare, Salt Lake City, Utah, USA" }, { "name": "Department of Emergency Medicine, Stanford Medicine, Palo Alto, California, USA" } ], "family": "Bledsoe", "given": "Joseph", "sequence": "additional" } ], "container-title": "Open Forum Infectious Diseases", "content-domain": { "crossmark-restriction": false, "domain": [] }, "created": { "date-parts": [ [ 2021, 6, 23 ] ], "date-time": "2021-06-23T01:00:39Z", "timestamp": 1624410039000 }, "deposited": { "date-parts": [ [ 2021, 7, 27 ] ], "date-time": "2021-07-27T12:52:09Z", "timestamp": 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