The impact of COVID-19 monoclonal antibodies on clinical outcomes: A retrospective cohort study

Nagler et al., American Journal of Health-System Pharmacy, doi:10.1093/ajhp/zxac295, Oct 2022

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Casirivimab/imdevimab

17th treatment shown to reduce risk in March 2021, now with p = 0.000073 from 34 studies, recognized in 52 countries. Efficacy is variant dependent.

Lower risk for hospitalization, progression, recovery, cases, and viral clearance.

No treatment is 100% effective. Protocols combine treatments.

5,700+ studies for 169 treatments. c19early.org

PSM retrospective 1,344 patients in the USA, showing lower hospitalization with monoclonal antibody treatment. Authors combine patients treated with bamlanivimab, bamlanivimab/etesevimab, or casirivimab/imdevimab.

Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for many omicron variants1-7.

Standard of Care (SOC) for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments8. Only expensive, high-profit treatments were approved. Low-cost treatments were excluded, reducing the probability of treatment—especially early—due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.

This study is excluded in meta analysis: results are only provided for use of one or more treatments within a class of treatments, results for each treatment are not provided.

Important missing comments or errors? Let us know.

Study covers casirivimab/imdevimab and bamlanivimab/etesevimab.

risk of death, 61.0% higher, RR 1.61, p = 0.40, treatment 1,344, control 1,344, propensity score matching.

risk of ICU admission, 51.0% higher, RR 1.51, p = 0.50, treatment 1,344, control 1,344, propensity score matching.

risk of hospitalization, 49.0% lower, RR 0.51, p < 0.001, treatment 1,344, control 1,344, propensity score matching.

risk of progression, 39.0% lower, RR 0.61, p < 0.001, treatment 1,344, control 1,344, ER visit, propensity score matching.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. Liu et al., Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2, bioRxiv, doi:10.1101/2021.12.14.472719.biorxiv.org, doi.org.

2. Sheward et al., Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron), bioRxiv, doi:10.1101/2021.12.19.473354.biorxiv.org, doi.org.

3. VanBlargan et al., An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies, bioRxiv, doi:10.1101/2021.12.15.472828.biorxiv.org, doi.org.

4. Tatham et al., Lack of Ronapreve (REGN-CoV; casirivimab and imdevimab) virological efficacy against the SARS-CoV 2 Omicron variant (B.1.1.529) in K18-hACE2 mice, bioRxiv, doi:10.1101/2022.01.23.477397.biorxiv.org, doi.org.

5. Pochtovyi et al., In Vitro Efficacy of Antivirals and Monoclonal Antibodies against SARS-CoV-2 Omicron Lineages XBB.1.9.1, XBB.1.9.3, XBB.1.5, XBB.1.16, XBB.2.4, BQ.1.1.45, CH.1.1, and CL.1, Vaccines, doi:10.3390/vaccines11101533.mdpi.com, doi.org.

6. Haars et al., Prevalence of SARS-CoV-2 Omicron Sublineages and Spike Protein Mutations Conferring Resistance against Monoclonal Antibodies in a Swedish Cohort during 2022–2023, Microorganisms, doi:10.3390/microorganisms11102417.mdpi.com, doi.org.

7. Uraki et al., Antiviral efficacy against and replicative fitness of an XBB.1.9.1 clinical isolate, iScience, doi:10.1016/j.isci.2023.108147.sciencedirect.com, doi.org.

8. c19early.org, c19early.org/soc/usa.html.c19early.org/soc/usa.html.

Nagler et al., 15 Oct 2022, retrospective, USA, peer-reviewed, mean age 59.5, 14 authors, study period 24 November, 2020 - 15 May, 2021. Contact: arielle.nagler@nyumc.org.

This Paper Casirivimab/i..All

Abstract: The impact of COVID-19 monoclonal antibodies on clinical outcomes: A retrospective cohort study Arielle R. Nagler, MD, The Ronald O. Perelman Department of Dermatology, NYU Grossman t us cr ip Leora I. Horwitz, MD, MHS, Department of Medicine and Department of Population Health, NYU Grossman School of Medicine, New York, NY, USA Simon Jones, PhD, Department of Population Health, NYU Grossman School of Medicine, M an New York, NY, USA d Christopher M. Petrilli, MD, NYU Grossman School of Medicine, New York, NY, USA ce York, NY, USA pt e Eduardo Iturrate, MD, Department of Medicine, NYU Grossman School of Medicine, New Ac Jennifer L. Lighter, MD, Division of Pediatric Infectious Diseases, Department of Pediatrics, NYU Grossman School of Medicine, New York, NY, USA Michael Phillips, MD, Division of Infectious Disease, Department of Medicine, NYU Grossman School of Medicine, New York, NY, USA © American Society of Health-System Pharmacists 2022. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. School of Medicine, New York, NY, USA Brian P. Bosworth, MD, Department of Medicine, NYU Grossman School of Medicine, New York, NY, and NYU Langone Health, New York, NY, USA Bruce Polsky, MD, Department of Medicine, NYU Long Island School of Medicine, New York, t us cr ip Frank M. Volpicelli, MD, Department of Medicine, NYU Grossman School of Medicine, New York, NY, USA an Isaac Dapkins, MD, Family Health Centers at NYU Langone, Brooklyn, NY, USA M Anand Viswanathan, MD, Department of Medicine, NYU Grossman School of Medicine, pt e d New York, NY, USA Fritz François, MD, Department of Medicine, NYU Grossman School of Medicine, New York, ce NY, and NYU Langone Health, New York, NY, USA Ac Gary Kalkut, MD, MPH, Division of Infectious Disease, Department of Medicine, NYU Grossman School of Medicine, New York, NY, and NYU Langone Health, New York, NY, USA Address correspondence to Dr. Nagler (Arielle.Nagler@nyumc.org). Twitter: @ArielleNaglerMD NY, USA Purpose: Despite progress in the treatment of coronavirus disease 2019 (COVID-19), including the development of monoclonal antibodies (mAbs), more clinical data to support the use of mAbs in outpatients with COVID-19 is needed. This study is designed to determine the impact of bamlanivimab, bamlanivimab/etesevimab, or t Methods: A retrospective cohort study was conducted at a single academic medical center us cr ip with 3 campuses in Manhattan, Brooklyn, and Long Island, NY. Patients 12 years of age or older who tested positive for COVID-19 or were treated with a COVID-19–specific therapy, including COVID-19 mAb therapies, at the study site between November 24, 2020, and May 15, 2021, were included. The primary outcomes included rates of emergency department M from the date of COVID-19 diagnosis. an (ED) visit, inpatient admission, intensive care unit (ICU) admission, or death within 30 days Results: A total of 1,344 mAb-treated patients were propensity matched to 1,344 patients d with COVID-19 patients who were not treated with mAb therapy. Within 30 days of pt e diagnosis, among the patients who received mAb therapy, 101 (7.5%) presented to the ED and 79 (5.9%) were admitted...

DOI record: { "DOI": "10.1093/ajhp/zxac295", "ISSN": [ "1079-2082", "1535-2900" ], "URL": "http://dx.doi.org/10.1093/ajhp/zxac295", "abstract": "Abstract\n \n Disclaimer\n In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.\n \n \n Purpose\n Despite progress in the treatment of coronavirus disease 2019 (COVID-19), including the development of monoclonal antibodies (mAbs), more clinical data to support the use of mAbs in outpatients with COVID-19 is needed. This study is designed to determine the impact of bamlanivimab, bamlanivimab/etesevimab, or casirivimab/imdevimab on clinical outcomes within 30 days of COVID-19 diagnosis.\n \n \n Methods\n A retrospective cohort study was conducted at a single academic medical center with 3 campuses in Manhattan, Brooklyn, and Long Island, NY. Patients 12 years of age or older who tested positive for COVID-19 or were treated with a COVID-19–specific therapy, including COVID-19 mAb therapies, at the study site between November 24, 2020, and May 15, 2021, were included. The primary outcomes included rates of emergency department (ED) visit, inpatient admission, intensive care unit (ICU) admission, or death within 30 days from the date of COVID-19 diagnosis.\n \n \n Results\n A total of 1,344 mAb-treated patients were propensity matched to 1,344 patients with COVID-19 patients who were not treated with mAb therapy. Within 30 days of diagnosis, among the patients who received mAb therapy, 101 (7.5%) presented to the ED and 79 (5.9%) were admitted. Among the patients who did not receive mAb therapy, 165 (12.3%) presented to the ED and 156 (11.6%) were admitted (relative risk [RR], 0.61 [95% CI, 0.50-0.75] and 0.51 [95% CI, 0.40-0.64], respectively). Four mAb patients (0.3%) and 2.64 control patients (0.2%) were admitted to the ICU (RR, 01.51; 95% CI, 0.45-5.09). Six mAb-treated patients (0.4%) and 3.37 controls (0.3%) died and/or were admitted to hospice (RR, 1.61; 95% CI, 0.54-4.83). mAb therapy in ambulatory patients with COVID-19 decreases the risk of ED presentation and hospital admission within 30 days of diagnosis.\n ", "author": [ { "affiliation": [ { "name": "The Ronald O. Perelman Department of Dermatology, NYU Grossman School of Medicine, New York , NY, USA" } ], "family": "Nagler", "given": "Arielle R", "sequence": "first" }, { "affiliation": [ { "name": "Department of Medicine and Department of Population Health, NYU Grossman School of Medicine, New York , NY, USA" } ], "family": "Horwitz", "given": "Leora I", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Population Health, NYU Grossman School of Medicine, New York , NY, USA" } ], "family": "Jones", "given": "Simon", "sequence": "additional" }, { "affiliation": [ { "name": "NYU Grossman School of Medicine, New York , NY, USA" } ], "family": "Petrilli", "given": "Christopher M", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, NYU Grossman School of Medicine, New York , NY, USA" } ], "family": "Iturrate", "given": "Eduardo", "sequence": "additional" }, { "affiliation": [ { "name": "Division of Pediatric Infectious Diseases, Department of Pediatrics, NYU Grossman School of Medicine, New York , NY, USA" } ], "family": "Lighter", "given": "Jennifer L", "sequence": "additional" }, { "affiliation": [ { "name": "Division of Infectious Disease, Department of Medicine, NYU Grossman School of Medicine, New York , NY, USA" } ], "family": "Phillips", "given": "Michael", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, NYU Grossman School of Medicine, New York , NY, andNYU Langone Health, New York, NY, USA" } ], "family": "Bosworth", "given": "Brian P", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, NYU Long Island School of Medicine, New York , NY, USA" } ], "family": "Polsky", "given": "Bruce", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, NYU Grossman School of Medicine, New York , NY, USA" } ], "family": "Volpicelli", "given": "Frank M", "sequence": "additional" }, { "affiliation": [ { "name": "Family Health Centers at NYU Langone, Brooklyn , NY, USA" } ], "family": "Dapkins", "given": "Isaac", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, NYU Grossman School of Medicine, New York , NY, USA" } ], "family": "Viswanathan", "given": "Anand", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Medicine, NYU Grossman School of Medicine, New York , NY, and NYU Langone Health, New York, NY, USA" } ], "family": "François", "given": "Fritz", "sequence": "additional" }, { "affiliation": [ { "name": "Division of Infectious Disease, Department of Medicine, NYU Grossman School of Medicine, New York , NY, and NYU Langone Health, New York, NY, USA" } ], "family": "Kalkut", "given": "Gary", "sequence": "additional" } ], "container-title": "American Journal of Health-System Pharmacy", "content-domain": { "crossmark-restriction": false, "domain": [] }, "created": { "date-parts": [ [ 2022, 10, 15 ] ], "date-time": "2022-10-15T17:06:42Z", "timestamp": 1665853602000 }, "deposited": { "date-parts": [ [ 2022, 10, 15 ] ], "date-time": "2022-10-15T17:06:43Z", "timestamp": 1665853603000 }, "indexed": { "date-parts": [ [ 2022, 10, 15 ] ], "date-time": "2022-10-15T17:42:43Z", "timestamp": 1665855763377 }, "is-referenced-by-count": 0, "issued": { "date-parts": [ [ 2022, 10, 15 ] ] }, "language": "en", "license": [ { "URL": "https://academic.oup.com/pages/standard-publication-reuse-rights", "content-version": "am", "delay-in-days": 0, "start": { "date-parts": [ [ 2022, 10, 15 ] ], "date-time": "2022-10-15T00:00:00Z", "timestamp": 1665792000000 } } ], "link": [ { "URL": "https://academic.oup.com/ajhp/advance-article-pdf/doi/10.1093/ajhp/zxac295/46539445/zxac295.pdf", "content-type": "application/pdf", "content-version": "am", "intended-application": "syndication" }, { "URL": "https://academic.oup.com/ajhp/advance-article-pdf/doi/10.1093/ajhp/zxac295/46539445/zxac295.pdf", "content-type": "unspecified", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "286", "original-title": [], "prefix": "10.1093", "published": { "date-parts": [ [ 2022, 10, 15 ] ] }, "published-online": { "date-parts": [ [ 2022, 10, 15 ] ] }, "publisher": "Oxford University Press (OUP)", "reference-count": 0, "references-count": 0, "relation": {}, "resource": { "primary": { "URL": "https://academic.oup.com/ajhp/advance-article/doi/10.1093/ajhp/zxac295/6761664" } }, "score": 1, "short-title": [], "source": "Crossref", "subject": [ "Health Policy", "Pharmacology" ], "subtitle": [], "title": "The impact of COVID-19 monoclonal antibodies on clinical outcomes: A retrospective cohort study", "type": "journal-article" }

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