Retrospective 2,335 bamlanivimab patients and 2,335 PSM controls in the USA, showing significantly lower hospitalization with treatment.
Intravenous bamlanivimab use associates with reduced hospitalization in high-risk patients with mild to moderate COVID-19
Ravindra Ganesh, Colin F Pawlowski, John C O’horo, Lori L Arndt, Richard F Arndt, Sarah J Bell, Dennis M Bierle, Molly Destro Borgen, Sara N Hanson, Alexander Heyliger, Jennifer J Larsen, Patrick J Lenehan, Robert Orenstein, Arjun Puranik, Leigh L Speicher, Sidna M Tulledge-Scheitel, A J Venkatakrishnan, Caroline G Wilker, Andrew D Badley, Raymund R Razonable
Journal of Clinical Investigation, doi:10.1172/jci151697
Clinical data to support the use of bamlanivimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) are needed. 2335 Patients who received single-dose bamlanivimab infusion between November 12, 2020, and February 17, 2021, were compared with a propensity-matched control of 2335 untreated patients with mild to moderate COVID-19 at Mayo Clinic facilities across 4 states. The primary outcome was the rate of hospitalization at days 14, 21, and 28. The median age of the population was 63 years; 47.3% of the bamlanivimab-treated cohort were 65 years or more; 49.3% were female and 50.7% were male. High-risk characteristics included hypertension (54.2%), BMI greater than or equal to 35 (32.4%), diabetes mellitus (26.5%), chronic lung disease (25.1%), malignancy (16.6%), and renal disease (14.5%). Patients who received bamlanivimab had lower all-cause hospitalization rates at days 14 (1.5% vs. 3.5%; risk ratio [RR], 0.41), 21 (1.9% vs. 3.9%; RR, 0.49), and 28 (2.5% vs. 3.9%; RR, 0.63). Secondary exploratory outcomes included lower intensive care unit (ICU) admission rates at days 14 (0.14% vs. 1%; RR, 0.14), 21 (0.25% vs.1%; RR, 0.25), and 28 (0.56% vs.1.1%; RR. 0.51) and lower […] Clinical Medicine Virology
Author contributions RG, CFP, and RRR conceived and designed the study. CFP, PJL, AP, AJV, JCO, RG, ADB, and RRR acquired, analyzed, or interpreted data. RG, CFP, and RRR drafted the manuscript. All authors critically revised the manuscript. CFP, PJL, AP, AJV, JCO, RG, and RRR performed statistical analysis. SJB, JJL, MDB, ADB, and DMB provided administrative, technical, or material support. RO, LLS, SMTS, CGW, SNH, DMB, RG, LLA, RFA, AH, and RRR supervised the project.
References
Austin, Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples, Stat Med,
doi:10.1002/sim.3697
Bariola, Impact of bamlanivimab monoclonal antibody treatment on hospitalization and mortality among non-hospitalized adults with SARS-CoV-2 infection, Open Forum Infect Dis,
doi:10.1093/ofid/ofab254
Bhimraj, Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19
Bierle, Influence of social and cultural factors on the decision to consent for monoclonal antibody treatment among high-risk patients with mild-moderate COVID-19, J Prim Care Community Health
Cardinal, Aitken, ANOVA for the Behavioral Sciences Researcher
Crane, Telemedicine consultations and follow-up of patients with COVID-19, Mayo Clin Proc
Kumar, Real-world experience of bamlanivimab for COVID-19: a case-control study
Richardson, Presenting characteristics, comorbidities, and outcomes among 5700 patients hospitalized with COVID-19 in the New York City Area, JAMA,
doi:10.1001/jama.2020.6775
Stuart, Prognostic score-based balance measures can be a useful diagnostic for propensity score methods in comparative effectiveness research, J Clin Epidemiol
Tian, Evaluating large-scale propensity score performance through real-world and synthetic data experiments, Int J Epidemiol,
doi:10.1093/ije/dyy120
Tulledge-Scheitel, A mobile unit overcomes the challenges to monoclonal antibody infusion for COVID-19 in skilled care facilities, J Am Geriatr Soc,
doi:10.1111/jgs.17090
Vora, SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with COVID-19
Yetmar, Monoclonal antibody therapy for COVID-19 in solid organ transplant recipients, Open Forum Infect Dis,
doi:10.1093/ofid/ofab255
Zhou, Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study, Lancet,
doi:10.1016/S0140-6736(20)30566-3
{ 'indexed': { 'date-parts': [[2021, 12, 13]],
'date-time': '2021-12-13T15:49:43Z',
'timestamp': 1639410583854},
'reference-count': 28,
'publisher': 'American Society for Clinical Investigation',
'issue': '19',
'funder': [ { 'DOI': '10.13039/100000871',
'name': 'Mayo Clinic',
'doi-asserted-by': 'publisher',
'award': ['NA']}],
'content-domain': {'domain': [], 'crossmark-restriction': False},
'short-container-title': [],
'published-print': {'date-parts': [[2021, 10, 1]]},
'DOI': '10.1172/jci151697',
'type': 'journal-article',
'created': {'date-parts': [[2021, 8, 19]], 'date-time': '2021-08-19T16:12:14Z', 'timestamp': 1629389534000},
'source': 'Crossref',
'is-referenced-by-count': 3,
'title': [ 'Intravenous bamlanivimab use associates with reduced hospitalization in high-risk patients '
'with mild to moderate COVID-19'],
'prefix': '10.1172',
'volume': '131',
'author': [ { 'ORCID': 'http://orcid.org/0000-0002-6877-1712',
'authenticated-orcid': False,
'given': 'Ravindra',
'family': 'Ganesh',
'sequence': 'first',
'affiliation': []},
{ 'ORCID': 'http://orcid.org/0000-0003-2781-7507',
'authenticated-orcid': False,
'given': 'Colin F.',
'family': 'Pawlowski',
'sequence': 'additional',
'affiliation': []},
{'given': 'John C.', 'family': 'O’Horo', 'sequence': 'additional', 'affiliation': []},
{'given': 'Lori L.', 'family': 'Arndt', 'sequence': 'additional', 'affiliation': []},
{ 'ORCID': 'http://orcid.org/0000-0003-4723-689X',
'authenticated-orcid': False,
'given': 'Richard F.',
'family': 'Arndt',
'sequence': 'additional',
'affiliation': []},
{'given': 'Sarah J.', 'family': 'Bell', 'sequence': 'additional', 'affiliation': []},
{ 'ORCID': 'http://orcid.org/0000-0003-3337-5645',
'authenticated-orcid': False,
'given': 'Dennis M.',
'family': 'Bierle',
'sequence': 'additional',
'affiliation': []},
{'given': 'Molly Destro', 'family': 'Borgen', 'sequence': 'additional', 'affiliation': []},
{'given': 'Sara N.', 'family': 'Hanson', 'sequence': 'additional', 'affiliation': []},
{ 'ORCID': 'http://orcid.org/0000-0002-3414-0832',
'authenticated-orcid': False,
'given': 'Alexander',
'family': 'Heyliger',
'sequence': 'additional',
'affiliation': []},
{'given': 'Jennifer J.', 'family': 'Larsen', 'sequence': 'additional', 'affiliation': []},
{'given': 'Patrick J.', 'family': 'Lenehan', 'sequence': 'additional', 'affiliation': []},
{'given': 'Robert', 'family': 'Orenstein', 'sequence': 'additional', 'affiliation': []},
{'given': 'Arjun', 'family': 'Puranik', 'sequence': 'additional', 'affiliation': []},
{'given': 'Leigh L.', 'family': 'Speicher', 'sequence': 'additional', 'affiliation': []},
{ 'given': 'Sidna M.',
'family': 'Tulledge-Scheitel',
'sequence': 'additional',
'affiliation': []},
{'given': 'A.J.', 'family': 'Venkatakrishnan', 'sequence': 'additional', 'affiliation': []},
{'given': 'Caroline G.', 'family': 'Wilker', 'sequence': 'additional', 'affiliation': []},
{ 'ORCID': 'http://orcid.org/0000-0001-7796-7680',
'authenticated-orcid': False,
'given': 'Andrew D.',
'family': 'Badley',
'sequence': 'additional',
'affiliation': []},
{ 'ORCID': 'http://orcid.org/0000-0001-5248-0227',
'authenticated-orcid': False,
'given': 'Raymund R.',
'family': 'Razonable',
'sequence': 'additional',
'affiliation': []}],
'member': '232',
'published-online': {'date-parts': [[2021, 10, 1]]},
'reference': [ { 'issue': '9',
'key': 'B1',
'first-page': '880',
'article-title': 'An EUA for bamlanivimab-a monoclonal antibody for COVID-19',
'volume': '325',
'year': '2020',
'journal-title': 'JAMA'},
{ 'issue': '1621',
'key': 'B2',
'first-page': '49',
'article-title': 'An EUA for bamlanivimab etesevimab for COVID-19',
'volume': '63',
'year': '2021',
'journal-title': 'Med Lett Drugs Ther'},
{ 'issue': '1614',
'key': 'B3',
'first-page': '201',
'article-title': 'An EUA for casirivimab imdevimab for COVID-19',
'volume': '62',
'year': '2020',
'journal-title': 'Med Lett Drugs Ther'},
{ 'key': 'B4',
'doi-asserted-by': 'crossref',
'unstructured': 'Jones BE, et al. LY-CoV555, a rapidly isolated potent neutralizing '
'antibody, provides protection in a non-human primate model of SARS-CoV-2 '
'infection [preprint]. https://doi.org/10.1101/2020.09.30.318972 Posted '
'on bioRxiv October 9, 2020',
'DOI': '10.1101/2020.09.30.318972'},
{ 'key': 'B5',
'unstructured': 'Coronavirus (COVID-19) update: FDA revokes emergency use authorization '
'for monoclonal antibody bamlanivimab. News release. U.S. Food and Drug '
'Administration; April 16, 2021. Accessed April 24, 2021. '
'https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab'},
{'key': 'B6', 'doi-asserted-by': 'publisher', 'DOI': '10.1056/NEJMoa2029849'},
{'key': 'B7', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/j.mayocp.2021.03.010'},
{ 'key': 'B8',
'unstructured': 'Bhimraj A, et al. Infectious Diseases Society of America Guidelines on '
'the Treatment and Management of Patients with COVID-19. '
'https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/ '
'Updated June 25, 2021. Accessed January 30, 2021'},
{ 'key': 'B9',
'unstructured': 'National Institutes of Health. The COVID-19 Treatment Guidelines Panel’s '
'Statement on the Emergency Use Authorization of Bamlanivimab for the '
'Treatment of COVID-19. '
'https://www.covid19treatmentguidelines.nih.gov/statement-on-bamlanivimab-eua/ '
'Updated August 4, 2021. Accessed January 30, 2021'},
{ 'key': 'B10',
'unstructured': 'Vora S. SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with '
'COVID-19. '
'https://pids.org/2020/11/19/sars-cov-2-neutralizing-antibody-ly-cov555-in-outpatients-with-covid-19/ '
'Updated November 19, 2020. Accessed January 30, 2021'},
{'key': 'B11', 'doi-asserted-by': 'publisher', 'DOI': '10.1093/ofid/ofab254'},
{ 'key': 'B12',
'doi-asserted-by': 'crossref',
'DOI': '10.1177/21501327211019282',
'article-title': 'Influence of social and cultural factors on the decision to consent for '
'monoclonal antibody treatment among high-risk patients with '
'mild-moderate COVID-19',
'volume': '12',
'author': 'Bierle',
'year': '2021',
'journal-title': 'J Prim Care Community Health'},
{ 'key': 'B13',
'article-title': 'Real-world experience of bamlanivimab for COVID-19: a case-control '
'study',
'author': 'Kumar',
'journal-title': 'Clin Infect Dis'},
{'key': 'B14', 'doi-asserted-by': 'publisher', 'DOI': '10.1093/ofid/ofab255'},
{'key': 'B15', 'doi-asserted-by': 'publisher', 'DOI': '10.1111/jgs.17090'},
{ 'issue': '9S',
'key': 'B16',
'doi-asserted-by': 'crossref',
'first-page': 'S33',
'DOI': '10.1016/j.mayocp.2020.06.051',
'article-title': 'Telemedicine consultations and follow-up of patients with COVID-19',
'volume': '95',
'author': 'Crane',
'year': '2020',
'journal-title': 'Mayo Clin Proc'},
{'key': 'B17', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/j.mayocpiqo.2020.12.003'},
{'key': 'B18', 'doi-asserted-by': 'publisher', 'DOI': '10.1001/jama.2020.6775'},
{'key': 'B19', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/S0140-6736(20)30566-3'},
{'key': 'B20', 'doi-asserted-by': 'publisher', 'DOI': '10.1111/j.1467-6419.2007.00527.x'},
{'key': 'B21', 'doi-asserted-by': 'publisher', 'DOI': '10.1093/ije/dyy120'},
{'key': 'B22', 'doi-asserted-by': 'publisher', 'DOI': '10.1002/sim.3697'},
{ 'issue': '8 Suppl',
'key': 'B23',
'doi-asserted-by': 'crossref',
'first-page': 'S84',
'DOI': '10.1016/j.jclinepi.2013.01.013',
'article-title': 'Prognostic score-based balance measures can be a useful diagnostic for '
'propensity score methods in comparative effectiveness research',
'volume': '66',
'author': 'Stuart',
'year': '2013',
'journal-title': 'J Clin Epidemiol'},
{'key': 'B24', 'doi-asserted-by': 'publisher', 'DOI': '10.3109/00952990.2011.600386'},
{ 'key': 'B25',
'doi-asserted-by': 'crossref',
'unstructured': 'Seabold S, Perktold J. Statsmodels: econometric and statistical modeling '
'with Python. Paper presented at: 9th Python in Science Conference; June '
'28–July 3, 2010; Austin, Texas, USA. Accessed August 16, 2021. '
'https://doi.org/10.25080/Majora-92bf1922-011',
'DOI': '10.25080/Majora-92bf1922-011'},
{'key': 'B26', 'doi-asserted-by': 'publisher', 'DOI': '10.1038/s41592-019-0686-2'},
{ 'key': 'B27',
'unstructured': 'lifelines. Version 0.26.0. Cam Davidson-Pilon; 2021. Accessed August 16, '
'2021. https://github.com/CamDavidsonPilon/lifelines'},
{'key': 'B28'}],
'container-title': ['Journal of Clinical Investigation'],
'original-title': [],
'language': 'en',
'link': [ { 'URL': 'https://www.jci.org/articles/view/151697/files/pdf',
'content-type': 'unspecified',
'content-version': 'vor',
'intended-application': 'similarity-checking'}],
'deposited': { 'date-parts': [[2021, 9, 30]],
'date-time': '2021-09-30T18:25:22Z',
'timestamp': 1633026322000},
'score': 1,
'subtitle': [],
'short-title': [],
'issued': {'date-parts': [[2021, 10, 1]]},
'references-count': 28,
'journal-issue': { 'issue': '19',
'published-online': {'date-parts': [[2021, 10, 1]]},
'published-print': {'date-parts': [[2021, 10, 1]]}},
'alternative-id': ['10.1172/JCI151697'],
'URL': 'http://dx.doi.org/10.1172/jci151697',
'relation': {},
'ISSN': ['1558-8238'],
'issn-type': [{'value': '1558-8238', 'type': 'electronic'}],
'subject': ['General Medicine'],
'published': {'date-parts': [[2021, 10, 1]]}}