Tixagevimab and Cilgavimab (Evusheld) as Pre-exposure Prophylaxis for COVID-19 in Patients With Inflammatory Bowel Disease: A Propensity Matched Cohort Study

DOI record: { "DOI": "10.1093/crocol/otad047", "ISSN": [ "2631-827X" ], "URL": "http://dx.doi.org/10.1093/crocol/otad047", "abstract": "<jats:title>Abstract</jats:title>\n <jats:sec>\n <jats:title>Background</jats:title>\n <jats:p>Tixagevimab and cilgavimab (Evusheld) are 2 fully human monoclonal antibodies that received emergency-use authorization on December 21, 2021, for pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in patients who are moderate–severely immunocompromised. The real-world efficacy of Evusheld in patients with inflammatory bowel disease (IBD) is not known.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Methods</jats:title>\n <jats:p>We conducted a retrospective cohort study using TriNetX, a multi-institutional database in patients with IBD who received Evusheld compared to patients with IBD who did not receive Evusheld (12.1.2021–10.28.2022). The primary outcome was to assess the risk of COVID-19 within 6 months. One-to-one propensity score matching (PSM) was performed for demographic parameters, comorbid conditions, IBD medications, and history of COVID-19. Risk was expressed as adjusted odds ratio (aOR) with 95% confidence interval (CI).</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Results</jats:title>\n <jats:p>Four hundred and eight patients (0.19%) with IBD received Evusheld (mean age 58.6 ± 15.4 years old, female 47.7%) during the study period. After PSM, there was no difference in the risk (aOR 0.88, 95% CI, 0.33–2.35) of COVID-19 in the Evusheld cohort compared to the IBD control cohort. No patients required ICU care or intubation/respiratory support or were deceased in the Evusheld cohort.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Conclusions</jats:title>\n <jats:p>Our study did not show that Evusheld decreases the risk of COVID-19 in patients with IBD. Prevention of moderate–severe COVID-19 in these patients should focus on vaccination strategies and early COVID-19 therapies.</jats:p>\n </jats:sec>", "author": [ { "ORCID": "http://orcid.org/0000-0002-6604-7712", "affiliation": [ { "name": "Division of Gastroenterology and Hepatology, MetroHealth Medical Center, Case Western Reserve University , Cleveland, OH , USA" } ], "authenticated-orcid": false, "family": "Desai", "given": "Aakash", "sequence": "first" }, { "ORCID": "http://orcid.org/0000-0001-8305-9742", "affiliation": [ { "name": "Division of Gastroenterology and Hepatology, Mayo Clinic , Jacksonville, FL , USA" } ], "authenticated-orcid": false, "family": "Hashash", "given": "Jana G", "sequence": "additional" }, { "affiliation": [ { "name": "Division of Gastroenterology & Hepatology, Allegheny Health Network , Pittsburgh, PA , USA" } ], "family": "Kochhar", "given": "Gursimran S", "sequence": "additional" }, { "affiliation": [ { "name": "Division of Gastroenterology and Hepatology, Mayo Clinic , Jacksonville, FL , USA" } ], "family": "Farraye", "given": "Francis A", "sequence": "additional" } ], "container-title": "Crohn's &amp; Colitis 360", "content-domain": { "crossmark-restriction": false, "domain": [] }, "created": { "date-parts": [ [ 2023, 9, 6 ] ], "date-time": "2023-09-06T16:30:20Z", "timestamp": 1694017820000 }, "deposited": { "date-parts": [ [ 2023, 9, 6 ] ], "date-time": "2023-09-06T16:30:27Z", "timestamp": 1694017827000 }, "indexed": { "date-parts": [ [ 2024, 2, 13 ] ], "date-time": "2024-02-13T17:26:03Z", "timestamp": 1707845163613 }, "is-referenced-by-count": 1, "issue": "3", "issued": { "date-parts": [ [ 2023, 7, 1 ] ] }, "journal-issue": { "issue": "3", "published-print": { "date-parts": [ [ 2023, 7, 1 ] ] } }, "language": "en", "license": [ { "URL": "https://creativecommons.org/licenses/by/4.0/", "content-version": "vor", "delay-in-days": 67, "start": { "date-parts": [ [ 2023, 9, 6 ] ], "date-time": "2023-09-06T00:00:00Z", "timestamp": 1693958400000 } } ], "link": [ { "URL": "https://academic.oup.com/crohnscolitis360/article-pdf/5/3/otad047/51393532/otad047.pdf", "content-type": "application/pdf", "content-version": "vor", "intended-application": "syndication" }, { "URL": "https://academic.oup.com/crohnscolitis360/article-pdf/5/3/otad047/51393532/otad047.pdf", "content-type": "unspecified", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "286", "original-title": [], "prefix": "10.1093", "published": { "date-parts": [ [ 2023, 7, 1 ] ] }, "published-online": { "date-parts": [ [ 2023, 9, 6 ] ] }, "published-other": { "date-parts": [ [ 2023, 7, 1 ] ] }, "published-print": { "date-parts": [ [ 2023, 7, 1 ] ] }, "publisher": "Oxford University Press (OUP)", "reference": [ { "DOI": "10.1126/scitranslmed.abl8124", "article-title": "The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans", "author": "Loo", "doi-asserted-by": "crossref", "first-page": "eabl8124", "issue": "635", "journal-title": "Sci Transl Med.", "key": "2023090616205803500_CIT0001", "volume": "14", "year": "2022" }, { "DOI": "10.1056/NEJMoa2116620", "article-title": "Intramuscular AZD7442 (tixagevimab–cilgavimab) for prevention of COVID-19", "author": "Levin", "doi-asserted-by": "crossref", "first-page": "2188", "issue": "23", "journal-title": "N Engl J Med.", "key": "2023090616205803500_CIT0002", "volume": "386", "year": "2022" }, { "key": "2023090616205803500_CIT0003" }, { "DOI": "10.1016/j.cmi.2022.07.015", "article-title": "Pre-exposure prophylaxis with tixagevimab and cilgavimab (Evusheld©) for COVID-19 among 1112 severely immunocompromised patients", "author": "Nguyen", "doi-asserted-by": "crossref", "first-page": "1654.e1", "issue": "12", "journal-title": "Clin Microbiol Infect", "key": "2023090616205803500_CIT0004", "volume": "28", "year": "2022" }, { "DOI": "10.1016/j.amjmed.2022.08.019", "article-title": "The prevention of COVID-19 in high-risk patients using tixagevimab–cilgavimab (Evusheld): Real-world experience at a large academic center", "author": "Al-Obaidi", "doi-asserted-by": "crossref", "first-page": "96", "issue": "1", "journal-title": "Am J Med.", "key": "2023090616205803500_CIT0005", "volume": "136", "year": "2022" }, { "DOI": "10.1093/ibd/izac131", "article-title": "A systematic review of Crohn’s disease case definitions in administrative or claims databases", "author": "Hutfless", "doi-asserted-by": "crossref", "first-page": "705", "issue": "5", "journal-title": "Inflamm Bowel Dis.", "key": "2023090616205803500_CIT0006", "volume": "29", "year": "022" }, { "DOI": "10.1093/ibd/izac252", "article-title": "Effect of 2 vs 3 doses of COVID-19 vaccine in patients with inflammatory bowel disease: a population-based propensity matched analysis", "author": "Desai", "doi-asserted-by": "crossref", "first-page": "izac252", "journal-title": "Inflamm Bowel Dis.", "key": "2023090616205803500_CIT0007", "year": "2022" }, { "DOI": "10.3390/v14091999", "article-title": "A critical analysis of the use of cilgavimab plus tixagevimab monoclonal antibody cocktail (EvusheldTM) for COVID-19 prophylaxis and treatment", "author": "Focosi", "doi-asserted-by": "crossref", "first-page": "1999", "issue": "9", "journal-title": "Viruses", "key": "2023090616205803500_CIT0008", "volume": "14", "year": "2022" }, { "DOI": "10.1097/RHU.0000000000001907", "article-title": "Real-world experience of tixagevimab and cilgavimab (Evusheld) in rheumatologic patients on rituximab", "author": "Ocon", "doi-asserted-by": "crossref", "first-page": "109", "issue": "2", "journal-title": "J Clin Rheumatol", "key": "2023090616205803500_CIT0009", "volume": "29", "year": "2022" }, { "DOI": "10.1016/j.ekir.2022.08.019", "article-title": "Tixagevimab and cilgavimab (Evusheld) in rituximab-treated antineutrophil cytoplasmic antibody vasculitis patients", "author": "Aqeel", "doi-asserted-by": "crossref", "first-page": "2537", "issue": "11", "journal-title": "Kidney Int Rep", "key": "2023090616205803500_CIT0010", "volume": "7", "year": "2022" }, { "DOI": "10.1111/ajt.17128", "article-title": "Tixagevimab/cilgavimab pre-exposure prophylaxis is associated with lower breakthrough infection risk in vaccinated solid organ transplant recipients during the omicron wave", "author": "Al Jurdi", "doi-asserted-by": "crossref", "first-page": "3130", "issue": "12", "journal-title": "Am J Transplant.", "key": "2023090616205803500_CIT0011", "volume": "22", "year": "2022" }, { "article-title": "Efficacy of Paxlovid and Lagevrio for COVID-19 infection in patients with inflammatory bowel disease: a propensity-matched study", "author": "Hashah", "issue": "3", "journal-title": "Clin Gastroenterol Hepatol.", "key": "2023090616205803500_CIT0012", "volume": "21", "year": "2022" }, { "author": "FDA announces Evusheld is not currently authorized for emergency use in the U.S", "key": "2023090616205803500_CIT0013", "year": "2023" } ], "reference-count": 13, "references-count": 13, "relation": {}, "resource": { "primary": { "URL": "https://academic.oup.com/crohnscolitis360/article/doi/10.1093/crocol/otad047/7261634" } }, "score": 1, "short-title": [], "source": "Crossref", "subject": [ "Gastroenterology" ], "subtitle": [], "title": "Tixagevimab and Cilgavimab (Evusheld) as Pre-exposure Prophylaxis for COVID-19 in Patients With Inflammatory Bowel Disease: A Propensity Matched Cohort Study", "type": "journal-article", "volume": "5" }