Lack of effectiveness of Bebtelovimab monoclonal antibody among high-risk patients with SARS-Cov-2 Omicron during BA.2, BA.2.12.1 and BA.5 subvariants dominated era

{ 'indexed': {'date-parts': [[2023, 4, 29]], 'date-time': '2023-04-29T04:34:58Z', 'timestamp': 1682742898480}, 'reference-count': 31, 'publisher': 'Public Library of Science (PLoS)', 'issue': '4', 'license': [ { 'start': { 'date-parts': [[2023, 4, 28]], 'date-time': '2023-04-28T00:00:00Z', 'timestamp': 1682640000000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'http://creativecommons.org/licenses/by/4.0/'}], 'funder': [ {'name': 'Shionogi Inc. and La Jolla pharmaceuticals'}, {'DOI': '10.13039/501100019123', 'name': 'AiCuris', 'doi-asserted-by': 'publisher'}], 'content-domain': {'domain': ['www.plosone.org'], 'crossmark-restriction': False}, 'abstract': '<jats:p>Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron subvariants are ' 'expected to be resistant to Bebtelovimab (BEB) monoclonal antibody (MAb) and the real-world ' 'experience regarding its effectiveness is scarce. This retrospective cohort study reports a ' 'data analysis in Banner Healthcare System (a large not-for-profit organization) between ' '4/5/2022 and 8/1/2022 and included 19,778 Coronavirus disease-19 (COVID-19) positive (by PCR ' 'or direct antigen testing) patients who were selected from Cerner-Electronic Health Record ' 'after the exclusions criteria were met. The study index date for cohort was determined as the ' 'date of BEB MAb administration or the date of the first positive COVID-19 testing. The cohort ' 'consist of COVID-19 infected patients who received BEB MAb (N = 1,091) compared to propensity ' 'score (PS) matched control (N = 1,091). The primary composite outcome was the incidence of ' '30-day all-cause hospitalization and/or mortality. All statistical analyses were conducted on ' 'the paired (matched) dataset. For the primary composite outcome, the event counts and ' 'percentages were reported. Ninety-five percent Clopper-Pearson confidence intervals for ' 'percentages were computed. The study cohorts were 1:1 propensity matched without replacement ' 'across 26 covariates using an optimal matching algorithm that minimizes the sum of absolute ' 'pairwise distance across the matched sample after fitting and using logistic regression as ' 'the distance function. The pairs were matched exactly on patient vaccination status, BMI ' 'group, age group and diabetes status. Compared to the PS matched control group (2.6%; 95% ' 'confidence interval [CI]: 1.7%, 3.7%), BEB MAb use (2.2%; 95% CI: 1.4%, 3.3%) did not ' 'significantly reduce the incidence of the primary outcome (p = 0.67). In the subgroup ' 'analysis, we observed similar no-difference trends regarding the primary outcomes for the ' 'propensity rematched BEB MAb treated and untreated groups, stratified by patient vaccination ' 'status, age (&lt;65 years or ≥65), and immunocompromised status (patients with HIV/AIDS or ' 'solid organ transplants or malignancy including lymphoproliferative disorder). The number ' 'needed to treat (1/0.026–0.022) with BEB MAb was 250 to avoid one hospitalization and/or ' 'death over 30 days. The BEB MAb use lacked efficacy in patients with SARS-CoV-2 Omicron ' 'subvariants (mainly BA.2, BA.2.12.1, and BA.5) in the Banner Healthcare System in the ' 'Southwestern United States.</jats:p>', 'DOI': '10.1371/journal.pone.0279326', 'type': 'journal-article', 'created': {'date-parts': [[2023, 4, 28]], 'date-time': '2023-04-28T17:25:19Z', 'timestamp': 1682702719000}, 'page': 'e0279326', 'update-policy': 'http://dx.doi.org/10.1371/journal.pone.corrections_policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Lack of effectiveness of Bebtelovimab monoclonal antibody among high-risk patients with ' 'SARS-Cov-2 Omicron during BA.2, BA.2.12.1 and BA.5 subvariants dominated era', 'prefix': '10.1371', 'volume': '18', 'author': [ {'given': 'Srilekha', 'family': 'Sridhara', 'sequence': 'first', 'affiliation': []}, {'given': 'Ahmet B.', 'family': 'Gungor', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-5760-4276', 'authenticated-orcid': True, 'given': 'Halil K.', 'family': 'Erol', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mohanad', 'family': 'Al-Obaidi', 'sequence': 'additional', 'affiliation': []}, {'given': 'Tirdad T.', 'family': 'Zangeneh', 'sequence': 'additional', 'affiliation': []}, {'given': 'Edward J.', 'family': 'Bedrick', 'sequence': 'additional', 'affiliation': []}, {'given': 'Venkatesh K.', 'family': 'Ariyamuthu', 'sequence': 'additional', 'affiliation': []}, {'given': 'Aneesha', 'family': 'Shetty', 'sequence': 'additional', 'affiliation': []}, {'given': 'Abd A.', 'family': 'Qannus', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-9618-2336', 'authenticated-orcid': True, 'given': 'Katherine', 'family': 'Mendoza', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-9145-5283', 'authenticated-orcid': True, 'given': 'Sangeetha', 'family': 'Murugapandian', 'sequence': 'additional', 'affiliation': []}, {'given': 'Gaurav', 'family': 'Gupta', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-2378-9302', 'authenticated-orcid': True, 'given': 'Bekir', 'family': 'Tanriover', 'sequence': 'additional', 'affiliation': []}], 'member': '340', 'published-online': {'date-parts': [[2023, 4, 28]]}, 'reference': [ { 'issue': '13', 'key': 'pone.0279326.ref001', 'doi-asserted-by': 'crossref', 'first-page': '1239', 'DOI': '10.1001/jama.2020.2648', 'article-title': 'Characteristics of and Important Lessons From the Coronavirus Disease ' '2019 (COVID-19) Outbreak in China: Summary of a Report of 72314 Cases ' 'From the Chinese Center for Disease Control and Prevention.', 'volume': '323', 'author': 'Z Wu', 'year': '2020', 'journal-title': 'JAMA'}, { 'key': 'pone.0279326.ref002', 'unstructured': 'CDC COVID19 Symptoms. 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