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0 0.5 1 1.5 2+ Hospitalization 12% Improvement Relative Risk Case -35% Tixagevimab/c..  Desai et al.  Prophylaxis Is prophylaxis with tixagevimab/cilgavimab beneficial for COVID-19? Retrospective 782 patients in the USA (January - October 2022) More cases with tixagevimab/cilgavimab (not stat. sig., p=0.18) Desai et al., Crohn's & Colitis 360, Sep 2023 Favors tixagevimab/ci.. Favors control

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

Desai et al., Crohn's & Colitis 360, doi:10.1093/crocol/otad047
Sep 2023  
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TriNetX PSM retrospective 408 IBD patients receiving tixagevimab/cilgavimab and matched controls, showing no significant difference in COVID-19 cases or hospitalization.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2.75.2, BA.4.6, and BQ.1.1 Planas.
risk of hospitalization, 12.0% lower, OR 0.88, p = 0.81, treatment 391, control 391, RR approximated with OR.
risk of case, 35.0% higher, OR 1.35, p = 0.18, treatment 391, control 391, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Desai et al., 6 Sep 2023, retrospective, USA, peer-reviewed, 4 authors, study period 1 January, 2022 - 28 October, 2022.
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Tixagevimab and Cilgavimab (Evusheld) as Pre-exposure Prophylaxis for COVID-19 in Patients With Inflammatory Bowel Disease: A Propensity Matched Cohort Study
MD, * Aakash Desai, MD, MSc Jana G Hashash, MD Gursimran S Kochhar, MD, MSc Francis A Farraye
Crohn's & Colitis 360, doi:10.1093/crocol/otad047
Background: 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. Methods: 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). Results: 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. Conclusions: 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.
Author Contributions A.D.: Data collection, data analysis and preparation of manuscript. J.G.H. and G.S.K.: Data interpretation and critical revision of the manuscript. F.A.F.: Study conceptualization, data interpretation, critical revision, and final approval of the manuscript. Conflicts of Interest A.D.: None exists. J.G.H. holds the position of Associate Editor for Crohn's & Colitis 360 and has been recused from reviewing or making decisions for the manuscript. G.S.K.: Advisor Board: Corvetas Research Foundation, Lilly Pharmaceuticals, GIE medical; Stock options: Digbi Health. F.A.F. is a consultant for BMS, Braintree Labs, GSK, IBD Educational Group, Innovation Pharmaceuticals, Janssen, Pfizer and Sebela. He sits on a DSMB for Adiso Therapeutics and Lilly.
Aqeel, Geetha, Tixagevimab and cilgavimab (Evusheld) in rituximab-treated antineutrophil cytoplasmic antibody vasculitis patients, Kidney Int Rep, doi:10.1016/j.ekir.2022.08.019
Coronavirus, COVID-19) update: FDA authorizes new long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 in certain individuals, FDA. Published
Desai, Deepak, Cross, Effect of 2 vs 3 doses of COVID-19 vaccine in patients with inflammatory bowel disease: a population-based propensity matched analysis, Inflamm Bowel Dis, doi:10.1093/ibd/izac252
Focosi, Casadevall, A critical analysis of the use of cilgavimab plus tixagevimab monoclonal antibody cocktail (Evusheld TM ) for COVID-19 prophylaxis and treatment, Viruses, doi:10.3390/v14091999
Gungor, Kurtin, Mathias, Tanriover, Zangeneh, The prevention of COVID-19 in high-risk patients using tixagevimab-cilgavimab (Evusheld): Real-world experience at a large academic center, Am J Med, doi:10.1016/j.amjmed.2022.08.019
Hashah, Desai, Kochhar, Farraye, Efficacy of Paxlovid and Lagevrio for COVID-19 infection in patients with inflammatory bowel disease: a propensity-matched study, Clin Gastroenterol Hepatol, doi:10.1016/j.cgh.2022.09.011
Hutfless, Jasper, Tilak, A systematic review of Crohn's disease case definitions in administrative or claims databases, Inflamm Bowel Dis, doi:10.1093/ibd/izac131
Jurdi, Morena, Cote, Bethea, Azzi et al., Tixagevimab/cilgavimab pre-exposure prophylaxis is associated with lower breakthrough infection risk in vaccinated solid organ transplant recipients during the omicron wave, Am J Transplant, doi:10.1111/ajt.17128
Levin, Ustianowski, Wit, Intramuscular AZD7442 (tixagevimab-cilgavimab) for prevention of COVID-19, N Engl J Med, doi:10.1056/nejmoa2116620
Loo, Mctamney, Arends, The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans, Sci Transl Med, doi:10.1126/scitranslmed.abl8124
Nguyen, Flahault, Chavarot, Pre-exposure prophylaxis with tixagevimab and cilgavimab (Evusheld©) for COVID-19 among 1112 severely immunocompromised patients, Clin Microbiol Infect, doi:10.1016/j.cmi.2022.07.015
Ocon, Mustafa, Real-world experience of tixagevimab and cilgavimab (Evusheld) in rheumatologic patients on rituximab, J Clin Rheumatol, doi:10.1097/rhu.0000000000001907
Please send us corrections, updates, or comments. Vaccines and treatments are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment, vaccine, or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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