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All Studies   Meta Analysis    Recent:   

Real-world Assessment of 2,879 COVID-19 Patients Treated with Monoclonal Antibody Therapy: A Propensity Score-Matched Cohort Study

Cooper et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab512
Oct 2021  
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Mortality -7% unadjusted Improvement Relative Risk Mortality (b) 45% unadjusted Mortality (c) -17% unadjusted ICU admission 17% unadjusted ICU admission (b) 58% unadjusted ICU admission (c) 9% unadjusted Hospitalization 24% primary, unadjusted Hospitalization (b) 5% primary, unadjusted Hospitalization (c) 28% unadjusted Bamlanivimab/e..  Cooper et al.  EARLY TREATMENT Is early treatment with bamlanivimab/etesevimab beneficial for COVID-19? Retrospective 11,434 patients in the USA Lower hospitalization with bamlanivimab/etesevimab (p=0.00046) c19early.org Cooper et al., Open Forum Infectious D.., Oct 2021 Favorsbamlanivimab/e.. Favorscontrol 0 0.5 1 1.5 2+
20th treatment shown to reduce risk in May 2021
 
*, now with p = 0.00036 from 21 studies, recognized in 7 countries. Efficacy is variant dependent.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 75 treatments. c19early.org
Retrospective 2,879 patients and matched controls in the USA, showing significantly lower mortality and hospitalization with monoclonal antibody treatment (bamlanivimab, bamlanivimab/etesevimab, or casirivimab/imdevimab). There was significantly lower hospitalization with casirivimab/imdevimab compared to bamlanivimab or bamlanivimab/etesevimab. PSM and multivariate analysis is only provided for all treatments combined.
Efficacy is highly variant dependent. In Vitro research suggests a lack of efficacy for omicron1-5.
This study is excluded in the after exclusion results of meta analysis: unadjusted results with no group details.
Study covers casirivimab/imdevimab and bamlanivimab/etesevimab.
risk of death, 7.0% higher, RR 1.07, p = 0.86, treatment 12 of 2,900 (0.4%), control 33 of 8,534 (0.4%), unadjusted, all bamlanivimab.
risk of death, 45.3% lower, RR 0.55, p = 1.00, treatment 1 of 473 (0.2%), control 33 of 8,534 (0.4%), NNT 571, unadjusted, bamlanivimab/etesevimab.
risk of death, 17.2% higher, RR 1.17, p = 0.59, treatment 11 of 2,427 (0.5%), control 33 of 8,534 (0.4%), unadjusted, bamlanivimab.
risk of ICU admission, 16.9% lower, RR 0.83, p = 0.51, treatment 24 of 2,900 (0.8%), control 85 of 8,534 (1.0%), NNT 594, unadjusted, all bamlanivimab.
risk of ICU admission, 57.5% lower, RR 0.42, p = 0.33, treatment 2 of 473 (0.4%), control 85 of 8,534 (1.0%), NNT 174, unadjusted, bamlanivimab/etesevimab.
risk of ICU admission, 9.0% lower, RR 0.91, p = 0.81, treatment 22 of 2,427 (0.9%), control 85 of 8,534 (1.0%), NNT 1117, unadjusted, bamlanivimab.
risk of hospitalization, 24.2% lower, RR 0.76, p < 0.001, treatment 181 of 2,900 (6.2%), control 703 of 8,534 (8.2%), NNT 50, unadjusted, all bamlanivimab, primary outcome.
risk of hospitalization, 5.0% lower, RR 0.95, p = 0.86, treatment 37 of 473 (7.8%), control 703 of 8,534 (8.2%), NNT 241, unadjusted, bamlanivimab/etesevimab, primary outcome.
risk of hospitalization, 28.0% lower, RR 0.72, p < 0.001, treatment 144 of 2,427 (5.9%), control 703 of 8,534 (8.2%), NNT 43, unadjusted, bamlanivimab.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Cooper et al., 8 Oct 2021, retrospective, USA, peer-reviewed, 9 authors.
This PaperBamlaniv../e..All
Real-world Assessment of 2,879 COVID-19 Patients Treated with Monoclonal Antibody Therapy: A Propensity Score-Matched Cohort Study
PharmD Megan H Cooper, Paul A Christensen, Eric Salazar, Katherine K Perez, Edward A Graviss, Duc Nguyen, James M Musser, Howard J Huang, Michael G Liebl
doi:10.1093/ofid/ofab512/6384727
We assessed the outcomes of 2,879 SARS-CoV-2-positive patients transfused with one of three available monoclonal antibody (mAbs) treatments compared to a propensity-matched control cohort. We found that administration of mAbs significantly reduced 28-day hospitalizations and mortality.
A c c e p t e d M a n u s c r i p t 14 Monoclonal antibodies are susceptible to the evolution of viral resistance mutations in target epitopes, and the EUA for bamlanivimab was revoked due to demonstrated resistance of emerging variants (https://www.fda.gov/media/147629/download). Similarly, the EUA for bamlanivimab and etesevimab was recently revoked (June 25, 2021), due to the increasing prevalence of the P.1 and B.1.351 variants (www.covid19.lilly.com/bam-ete) that have been shown to escape certain mAbs. 23, 26 Combination mAbs that bind non-overlapping epitopes reduce the risk of resistance and have a clear advantage, and continued monitoring and assessment of emerging variants and their susceptibility to natural or induced immunity and therapeutic antibodies remains crucial. In summary, our propensity score-matched analysis confirms that early infusion of neutralizing mAbs to COVID-19 patients significantly reduced hospitalization and mortality among a large cohort of high-risk individuals. These data support continued widespread efforts to make early passive immune therapy available to COVID-19 patients. Potential Conflicts of Interest All authors report no conflicts of interest related to this study. A c c e p t e d M a n u s c r i p t 15 The study was reviewed and approved by the Houston Methodist Research Institute Institutional Review Board (IRB PRO00029666). Given the study design, patient's written consent was not required. However, verbal and written..
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Chen, Xiong, Bao, Shi, Convalescent plasma as a potential therapy for COVID-19, Lancet Infect Dis
Dougan, Nirula, Azizad, Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19, N Engl J Med, doi:10.1056/NEJMoa2102685
Duan, Liu, Li, Effectiveness of convalescent plasma therapy in severe COVID-19 patients, Proc Natl Acad Sci U S A
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Gottlieb, Nirula, Chen, Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial, JAMA
Hoffmann, Arora, Gross, SARS-CoV-2 variants B.1.351 and P.1 escape from neutralizing antibodies, Cell
Jenks, Aslam, Horton, Early Monoclonal Antibody Administration Can Reduce Both Hospitalizations and Mortality in High-Risk Outpatients with COVID-19, Clin Infect Dis
Kumar, Wu, Stosor, Real-World Experience of Bamlanivimab for COVID-19: A Case-Control Study, Clin Infect Dis
Long, Olsen, Christensen, Molecular Architecture of Early Dissemination and Massive Second Wave of the SARS-CoV-2 Virus in a Major Metropolitan Area, mBio
Long, Olsen, Christensen, Sequence Analysis of 20,453 Severe Acute Respiratory Syndrome Coronavirus 2 Genomes from the Houston Metropolitan Area
Salazar, Christensen, Graviss, Significantly Decreased Mortality in a Large Cohort of Coronavirus Disease 2019 (COVID-19) Patients Transfused Early with Convalescent Plasma Containing High-Titer Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike Protein IgG, Am J Pathol
Salazar, Perez, Ashraf, Treatment of Coronavirus Disease 2019 (COVID-19) Patients with Convalescent Plasma, Am J Pathol
Stuart, Lee, Leacy, Prognostic score-based balance measures can be a useful diagnostic for propensity score methods in comparative effectiveness research, J Clin Epidemiol
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{ 'indexed': {'date-parts': [[2023, 5, 8]], 'date-time': '2023-05-08T07:52:32Z', 'timestamp': 1683532352537}, 'reference-count': 0, 'publisher': 'Oxford University Press (OUP)', 'license': [ { 'start': { 'date-parts': [[2021, 10, 8]], 'date-time': '2021-10-08T00:00:00Z', 'timestamp': 1633651200000}, 'content-version': 'am', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by-nc-nd/4.0/'}], 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'abstract': '<jats:title>Abstract</jats:title>\n' ' <jats:sec>\n' ' <jats:title>Background</jats:title>\n' ' <jats:p>SARS-CoV-2 continues to spread globally and cause significant ' 'morbidity and mortality. Anti-spike protein monoclonal antibody (mAb) therapy has been shown ' 'to prevent progression to severe COVID-19 disease. The objective of this study was to report ' 'the outcomes of high-risk, SARS-CoV-2-positive patients infused with one of the three mAb ' 'available through FDA emergency use authorization (EUA).</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>A total of 4,328 SARS-CoV-2-positive patients that satisfied EUA ' 'criteria for eligibility for receiving mAb therapy were infused with bamlanivimab or ' 'combination therapies bamlanivimab-etesevimab or casirivimab-imdevimab from November 22, ' '2020, to May 31, 2021, at six infusion clinics and multiple emergency departments within the ' 'eight Houston Methodist Hospitals in Houston, Texas. The primary outcome of hospital ' 'admission within 14- and 28-days post-infusion was assessed relative to a propensity-score ' 'matched cohort, matched based on age, race/ethnicity, median income by zip code, body mass ' 'index, comorbidities, and positive PCR date. Secondary outcomes included ICU admission and ' 'mortality.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>A total of 2,879 infused patients and matched controls were ' 'included in the analysis, including 1,718 patients infused with bamlanivimab, 346 patients ' 'infused with bamlanivimab-etesevimab, and 815 patients infused with casirivimab-imdevimab. ' 'Hospital admission and mortality rates were significantly decreased overall in mAb-infused ' 'patients relative to matched controls. Among the infused cohort, those who received ' 'casirivimab-imdevimab had significantly decreased rate of admission relative to the other two ' 'mAbs groups (aRR = 0.51, p=0.001).</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>Treatment with bamlanivimab, bamlanivimab-etesevimab, or ' 'casirivimab-imdevimab significantly decreased the number of patients who progressed to severe ' 'COVID-19 disease and required hospitalization.</jats:p>\n' ' </jats:sec>', 'DOI': '10.1093/ofid/ofab512', 'type': 'journal-article', 'created': {'date-parts': [[2021, 10, 9]], 'date-time': '2021-10-09T01:52:08Z', 'timestamp': 1633744328000}, 'source': 'Crossref', 'is-referenced-by-count': 9, 'title': 'Real-world Assessment of 2,879 COVID-19 Patients Treated with Monoclonal Antibody Therapy: A ' 'Propensity Score-Matched Cohort Study', 'prefix': '10.1093', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-7531-4376', 'authenticated-orcid': False, 'given': 'Megan H', 'family': 'Cooper', 'sequence': 'first', 'affiliation': [ { 'name': 'Department of Pharmacy, Houston Methodist Hospital, Houston, ' 'Texas, USA'}]}, { 'given': 'Paul A', 'family': 'Christensen', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Pathology and Genomic Medicine, Houston Methodist ' 'Hospital, Houston, Texas, USA'}]}, { 'given': 'Eric', 'family': 'Salazar', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Pathology and Genomic Medicine, Houston Methodist ' 'Hospital, Houston, Texas, USA'}]}, { 'given': 'Katherine K', 'family': 'Perez', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Pharmacy, Houston Methodist Hospital, Houston, ' 'Texas, USA'}, { 'name': 'Department of Pathology and Genomic Medicine, Houston Methodist ' 'Hospital, Houston, Texas, USA'}]}, { 'given': 'Edward A', 'family': 'Graviss', 'sequence': 'additional', 'affiliation': [ { 'name': 'Center for Molecular and Translational Human Infectious Diseases ' 'Research, Houston Methodist Research Institute, Houston, Texas, ' 'USA'}]}, { 'given': 'Duc', 'family': 'Nguyen', 'sequence': 'additional', 'affiliation': [ { 'name': 'Center for Molecular and Translational Human Infectious Diseases ' 'Research, Houston Methodist Research Institute, Houston, Texas, ' 'USA'}]}, { 'given': 'James M', 'family': 'Musser', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Pathology and Genomic Medicine, Houston Methodist ' 'Hospital, Houston, Texas, USA'}, { 'name': 'Center for Molecular and Translational Human Infectious Diseases ' 'Research, Houston Methodist Research Institute, Houston, Texas, ' 'USA'}]}, { 'given': 'Howard J', 'family': 'Huang', 'sequence': 'additional', 'affiliation': [ { 'name': 'Division of Pulmonology, Pulmonary, Critical Care & Sleep ' 'Medicine, Houston Methodist Hospital, Houston, TX, USA'}]}, { 'given': 'Michael G', 'family': 'Liebl', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Pharmacy, Houston Methodist Hospital, Houston, ' 'Texas, USA'}]}], 'member': '286', 'published-online': {'date-parts': [[2021, 10, 8]]}, 'container-title': 'Open Forum Infectious Diseases', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'http://academic.oup.com/ofid/advance-article-pdf/doi/10.1093/ofid/ofab512/40533751/ofab512.pdf', 'content-type': 'application/pdf', 'content-version': 'am', 'intended-application': 'syndication'}, { 'URL': 'http://academic.oup.com/ofid/advance-article-pdf/doi/10.1093/ofid/ofab512/40533751/ofab512.pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2021, 10, 9]], 'date-time': '2021-10-09T01:52:10Z', 'timestamp': 1633744330000}, 'score': 1, 'resource': { 'primary': { 'URL': 'https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofab512/6384727'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021, 10, 8]]}, 'references-count': 0, 'URL': 'http://dx.doi.org/10.1093/ofid/ofab512', 'relation': {}, 'ISSN': ['2328-8957'], 'subject': ['Infectious Diseases', 'Oncology'], 'published': {'date-parts': [[2021, 10, 8]]}}
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