Impact of Sars-CoV-2 prophylaxis with tixagevimab-cilgavimab in high-risk patients with B-cell malignancies: a single-center retrospective study.

Main Article Content

Giovanni Manfredi Assanto ,
Matteo Totaro
Poggiali Rebecca
Delli Paoli Adele
Annechini Giorgia
D’Elia Gianna Maria
Aji Francesco
Petrucci Luigi
Fazio Francesca
Del Giudice Ilaria
Martelli Maurizio
Micozzi Alessandra
Giuseppe Gentile

Keywords

B-cell malignancies, COVID-19, tixagevimab-cilgavimab, Pre-exposure prophylaxis

Abstract

Severe Acute Respiratory Syndrome CoronaVirus‐2 (SARS‐CoV‐2) infection can result in different clinical manifestations (COVID-19), starting from asymptomatic disease to life threatening respiratory insufficiency. Onco-haematologic patients are at higher risk to develop severe COVID-19. In particular, patients affected by lymphoproliferative diseases, given the impaired cell-mediated and antibody-mediated immunity and treatment toxicity, develop more often a symptomatic and a more serious disease of Covid-19. Various therapeutic and prophylactic agents are being used against COVID‐19 such as antiviral drugs, vaccines and antiviral S‐protein monoclonal antibodies. Pre-exposure prophylaxis with AZD442/Evusheld (tixagevimab-cilgavimab) may be a complementary strategy to decrease the incidence or severity of COVID-19 for patients with B-cell malignancies. Tixagevimab-cilgavimab is a combination of two monoclonal antibodies that bind SARS-CoV-2 spike protein and inhibits the attachment to the surface of cells, preventing viral entry in the cell and COVID-19 development. In the setting of hematology real-life, few data are available on the impact of pre-exposure prophylaxis, given the multiple factors involved in the clinical behavior of SARS-CoV-2 . Our aim was to evaluate the clinical benefit and the safety of this strategy at our center.

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References

1. Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;
2. Vijenthira A, Gong IY, Fox TA, Booth S, Cook G, Fattizzo B, Martín-Moro F, Razanamahery J, Riches JC, Zwicker J, Patell R, Vekemans MC, Scarfò L, Chatzikonstantinou T, Yildiz H, Lattenist R, Mantzaris I, Wood WA, Hicks LK. Outcomes of patients with hematologic malignancies and COVID-19: a systematic review and meta-analysis of 3377 patients. Blood. 2020 Dec 17;136(25):2881-2892. doi: 10.1182/blood.2020008824.
3. Passamonti F, Nicastri E, Di Rocco A, Guarini A, Ibatici A, Luminari S, Mikulska M, Visco C. Management of patients with lymphoma and COVID-19: Narrative review and evidence-based practical recommendations. Hematol Oncol. 2023 Feb;41(1):3-15. doi: 10.1002/hon.3086. Epub 2022 Oct 25. PMID: 36251481; PMCID: PMC9874581.
4. Singh DD, Sharma A, Lee HJ, Yadav DK. SARS-CoV-2: Recent Variants and Clinical Efficacy of Antibody-Based Therapy. Front Cell Infect Microbiol. 2022 Feb 14;12:839170. doi: 10.3389/fcimb.2022.839170.
5. McLean G, Kamil J, Lee B, Moore P, Schulz TF, Muik A, Sahin U, Türeci Ö, Pather S. The Impact of Evolving SARS-CoV-2 Mutations and Variants on COVID-19 Vaccines. mBio. 2022 Apr 26;13(2):e0297921. doi: 10.1128/mbio.02979-21.
6. Assanto GM, Di Rocco A, Malfona F, Capriata M, Del Giudice I, Petrucci L, Girardi P, D'Elia GM, Martelli M, Gentile G, Micozzi A, Pulsoni A. Impact of anti-SARS-CoV-2 monoclonal antibodies in the management of patients with lymphoma and COVID19: A retrospective study. Hematol Oncol. 2022 Dec 15:10.1002/hon.3113. doi: 10.1002/hon.3113.
7. Della Pia A, Zhao C, Jandir P, Gupta A, Batistick M, Kim GYG, Xia Y, Ahn J, Magarelli G, Lukasik B, Leslie LA, Goy AH, Ip A, Feldman TA. Improved Survival of Lymphoma Patients with COVID-19 in the Modern Treatment and Vaccination Era. Cancers (Basel). 2022 Aug 31;14(17):4252. doi: 10.3390/cancers14174252. PMID: 36077782; PMCID: PMC9454633.
8. Levin MJ, Ustianowski A, De Wit S, Launay O, Avila M, Templeton A, Yuan Y, Seegobin S, Ellery A, Levinson DJ, Ambery P, Arends RH, Beavon R, Dey K, Garbes P, Kelly EJ, Koh GCKW, Near KA, Padilla KW, Psachoulia K, Sharbaugh A, Streicher K, Pangalos MN, Esser MT; PROVENT Study Group. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19. N Engl J Med. 2022 Jun 9;386(23):2188-2200. doi: 10.1056/NEJMoa2116620.
9. Ocon AJ, Ocon KE, Battaglia J, Low SK, Neupane N, Saeed H, Jamshed S, Mustafa SS. Real-World Effectiveness of Tixagevimab and Cilgavimab (Evusheld) in Patients With Hematological Malignancies. J Hematol. 2022 Dec;11(6):210-215. doi: 10.14740/jh1062. Epub 2022 Dec 1. PMID: 36632574; PMCID: PMC9822659.
10. Comunicato numero 695 , 3 agosto 2022, Agenzia Italiana del Farmaco, published online https://www.aifa.gov.it/documents/20142/1621225/Comunicato_AIFA_695.pdf
11. Marchesi F, Salmanton-García J, Buquicchio C, Itri F, Besson C, Dávila-Valls J, Martín-Pérez S, Fianchi L, Rahimli L, Tarantini G, et al. Passive pre-exposure immunization by tixagevimab/cilgavimab in patients with hematological malignancy and COVID-19: matched-paired analysis in the EPICOVIDEHA registry. J Hematol Oncol. 2023 Apr 1;16(1):32. doi: 10.1186/s13045-023-01423-7. PMID: 37005697; PMCID: PMC10066993.
12. Scarfò L, Cuneo A. COVID-19 prophylaxis: half-full or half-empty glass? Blood. 2023 Jan 12;141(2):130-132. doi: 10.1182/blood.2022018858. PMID: 36633884; PMCID: PMC9906282.
13. Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, et al. Clinical course and risk factors for mortality of adult inpatients with COVID‐19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395(10229):1054‐1062. https:// doi.org/10.1016/S0140‐6736(20)30566‐3
14. Dai M, Liu D, Liu M, Zhou F, Li G, Chen Z, Zhang Z, You H, Wu M, Zheng Q, et al. Patients with cancer appear more vulnerable to SARS‐CoV‐2: a multicenter study during the COVID‐19 outbreak. Cancer Discov. 2020;10(6):783‐791. https://doi.org/10.1158/2159‐ 8290.CD‐20‐0422
15. Davis JA, Granger K, Roubal K, Smith D, Gaffney KJ, McGann M, Cendagorta A, Thurlapati A, Herbst A, Hendrickson L, Hashmi H, Hess BT. Efficacy of tixagevimab-cilgavimab in preventing SARS-CoV-2 for patients with B-cell malignancies. Blood. 2023 Jan 12;141(2):200-203. doi: 10.1182/blood.2022018283.
16. Mauro FR, Visentin A, Giannarelli D, Molinari MC, Proietti G, Petrella M, Angotzi F, Pepe S, Trentin L, Baroncelli S, Giombini E, Meschi S, Maggi F, Focosi D. Pre-exposure prophylaxis with tixagevimab/cilgavimab in patients with chronic lymphocytic leukaemia treated with targeted agents. Br J Haematol. 2023 May;201(3):564-567. doi: 10.1111/bjh.18701.