{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T20:50:52Z","timestamp":1790542252074,"version":"4.1.0"},"reference-count":15,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,1,3]],"date-time":"2022-01-03T00:00:00Z","timestamp":1641168000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,1,3]],"date-time":"2022-01-03T00:00:00Z","timestamp":1641168000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Pharm Health Care Sci"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Casirivimab-imdevimab has been developed to neutralize SARS-CoV-2. The global clinical trials in outpatients documented several adverse effects (AE), which mandate caution in Japan where part of patients return home. To investigate post-infusion clinical events and their risk factors, we attempted a retrospective study.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Main body<\/jats:title>\n                <jats:p>Subjects were a consecutive series of inpatients with COVID-19 undergoing an infusion of casirivimab-imdevimab in our institute. The criteria for administration were in accordance with previous clinical trials, e.g., exclusion of patients necessitating oxygen supply. In Japan, however, SARS-CoV-2 vaccinees were eligible.<\/jats:p>\n                <jats:p>Methods were review of background factors of status, imaging, and laboratory findings for the outcome of post-infusion events such as temperature increase (Temp+), pulse oximetry below 94%, and other events. Also, we documented the drug efficacy.<\/jats:p>\n                <jats:p>Of a total of 96 patients with a median follow-up of 54\u2009days, one (1.0%) died who alone was an exception demanding oxygen supply. Other 95 patients (99.0%) recovered from fever and hypoxia by Day 4 and later had no worsening of COVID-19.<\/jats:p>\n                <jats:p>Median increase of body temperature was 1.0 degrees Celsius, which was used for computation of Temp+. Multivariate analysis showed that for Temp+ (<jats:italic>n<\/jats:italic>\u2009=\u200947), white blood cell counts more than 4.3\u2009\u00d7\u200910<jats:sup>3<\/jats:sup>\/microliter (Odds Ratio [OR] 2.593, 95% Confidence Interval [CI] 1.060\u20136.338, <jats:italic>P<\/jats:italic>\u00a0=\u20090.037) was at risk, whereas 2-time vaccination for SARS-CoV-2 (OR 0.128, 95% CI 0.026\u20130.636, <jats:italic>P<\/jats:italic>\u2009=\u20090.012) was a preventing factor. Likewise for lowered oximetry (<jats:italic>n<\/jats:italic>\u2009=\u200921), CT showing bilateral ground glass attenuation (OR 5.544, CI 1.599\u201319.228, <jats:italic>P<\/jats:italic>\u2009=\u20090.007) was a significant risk factor. Two patients (2.1%) showed bradycardia (asymptomatic, intervention not indicated) on Day 3 and recovery on Day 5.<\/jats:p>\n                <jats:p>Limitations for this study included the difficulty distinguishing AE from worsening of COVID-19, thus we documented as clinical events.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>For 24\u2009h after infusion of casirivimab-imdevimab, COVID-19 patients with increased white blood cell counts may be predisposed to temperature elevation more than 1.0 degrees centigrade, as may bilateral ground glass opacity to lowered oximetry. Thus, patients with leukocytosis and bilateral ground glass attenuation may need precaution for transient fever and hypoxia, respectively.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s40780-021-00233-8","type":"journal-article","created":{"date-parts":[[2022,1,3]],"date-time":"2022-01-03T11:03:43Z","timestamp":1641207823000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Casirivimab-imdevimab neutralizing SARS-CoV-2: post-infusion clinical events and their risk factors"],"prefix":"10.1186","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7183-8455","authenticated-orcid":false,"given":"Junichi","family":"Yoshida","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenichiro","family":"Shiraishi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tetsuro","family":"Tamura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhiro","family":"Otani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tetsuya","family":"Kikuchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akiko","family":"Mataga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takako","family":"Ueno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masao","family":"Tanaka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,1,3]]},"reference":[{"issue":"3","key":"233_CR1","doi-asserted-by":"publisher","first-page":"238","DOI":"10.1056\/NEJMoa2035002","volume":"384","author":"DM Weinreich","year":"2021","unstructured":"Weinreich DM, Sivapalasingam S, Norton T, Ali S, Gao H, Bhore R, et al. REGN-COV2, a neutralizing antibody cocktail, in outpatients with Covid-19. N Engl J Med. 2021;384(3):238\u201351. https:\/\/doi.org\/10.1056\/NEJMoa2035002.","journal-title":"N Engl J Med"},{"key":"233_CR2","unstructured":"Infectious Disease Society of America. Guideline. Immunomodulators. Last reviewed: September 3, 2021. https:\/\/www.idsociety.org\/covid-19-real-time-learning-network\/therapeutics-and-interventions\/immunomodulators\/. Accessed 18 Sep 2021."},{"key":"233_CR3","unstructured":"Pharmaceuticals and Medical Devices Agency. FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE AUTHORIZATION (EUA) OF REGEN-COVTM (casirivimab and imdevimab) AUTHORIZED USE. https:\/\/www.pmda.go.jp\/drugs\/2021\/P20210719001\/450045000_30300AMX00310_B100_1.pdf. Accessed 18 Sep 2021."},{"key":"233_CR4","unstructured":"U.S. Food and Drug Administration. FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE AUTHORIZATION (EUA) OF REGEN-COV\u00ae (casirivimab and imdevimab). https:\/\/www.fda.gov\/media\/145611\/download. Accessed 18 Sep 2021."},{"key":"233_CR5","unstructured":"National Institute of Infectious Diseases of Japan. Current Situation of Infection, September 1, 2021. 50th meeting of the COVID-19 advisory board of Ministry of Health, Labour and Welfare (September 1, 2021). https:\/\/wwwniidgojp\/niid\/en\/2019-ncov-e\/10636-covid19-ab50th-enhtml. Accessed 18 Sep 2021."},{"key":"233_CR6","unstructured":"U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Published: November 27, 2017. https:\/\/ctep.cancer.gov\/protocoldevelopment\/electronic_applications\/docs\/ctcae_v5_quick_reference_5x7.pdf. 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Vaccine. 2021;39(22):3053\u201366. https:\/\/doi.org\/10.1016\/j.vaccine.2021.01.055.","journal-title":"Vaccine."},{"issue":"11","key":"233_CR11","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01063-21","volume":"65","author":"Y Li","year":"2021","unstructured":"Li Y, Qi L, Bai H, Sun C, Xu S, Wang Y, et al. Safety, tolerability, pharmacokinetics, and immunogenicity of a monoclonal antibody (SCTA01) targeting SARS-CoV-2 in healthy adults: a randomized, double-blind, placebo-controlled. Phase I Study Antimicrob Agents Chemother. 2021;65(11):e0106321. https:\/\/doi.org\/10.1128\/AAC.01063-21.","journal-title":"Phase I Study Antimicrob Agents Chemother"},{"key":"233_CR12","doi-asserted-by":"crossref","unstructured":"Hsu JY, Mao YC, Liu PY, Lai KL. Pharmacology and Adverse Events of Emergency-Use Authorized Medication in Moderate to Severe COVID-19. 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Ethical Guidelines for Medical and Health Research Involving Human Subjects, Provisional Translation (as of July 2018) https:\/\/www.lifescience.mext.go.jp\/files\/pdf\/n2181_01.pdf. Accessed 18 Sep 2021."}],"container-title":["Journal of Pharmaceutical Health Care and Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s40780-021-00233-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s40780-021-00233-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s40780-021-00233-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,1,3]],"date-time":"2022-01-03T11:08:36Z","timestamp":1641208116000},"score":1,"resource":{"primary":{"URL":"https:\/\/jphcs.biomedcentral.com\/articles\/10.1186\/s40780-021-00233-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,1,3]]},"references-count":15,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2022,12]]}},"alternative-id":["233"],"URL":"https:\/\/doi.org\/10.1186\/s40780-021-00233-8","relation":{},"ISSN":["2055-0294"],"issn-type":[{"value":"2055-0294","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,1,3]]},"assertion":[{"value":"25 October 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 November 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 January 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The institution\u2019s Ethics Committee of Medical Research approved the current study with the reference number 2021SCHEC-16 [] and inclusive informed consent by the patients, in accordance with the governmental Guidelines [].","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"1"}}