Pre-exposure prophylaxis with tixagevimab/cilgavimab (AZD7442) prevents severe SARS-CoV-2 infection in recipients of allogeneic hematopoietic stem cell transplantation during the Omicron wave: a multicentric retrospective study of SFGM-TC

Jondreville, Ludovic; d’Aveni, Maud; Labussière‐Wallet, Hélène; Bourgeois, Amandine Le; Villate, Alban; Berceanu, Ana; Bezsera, Silvia-Maria; Thiebaut, Anne; Boissard-Simonet, Marion; Legrand, Marlène; Cornillon, Jérôme; Rubio, Marie‐Thérèse; Chevallier, Patrice; Nguyen, Stéphanie

doi:10.1186/s13045-022-01387-0

Cited by 29 publications

(52 citation statements)

References 9 publications

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“…On the other hand, the combination of imdevimab and casirivimab (Ronapreve/REGEN-COV) failed to neutralize any of the variants [ 22 ]. During the Omicron wave, tixagevimab and cilgavimab pre-exposure prophylaxis in immunosuppressed individuals, such as allogenic stem-cell or solid-organ transplant receipts, resulted in triple or double reduction in COVID-19 incidence when compared with untreated comparators [ 25 , 26 , 27 , 28 ]. Moreover, immunocompromised individuals treated with tixagevimab and cilgavimab were 92% less likely to be hospitalized or die when compared with the untreated group [ 26 ].…”

Section: Discussionmentioning

confidence: 99%

Tixagevimab and Cilgavimab (Evusheld™) Prophylaxis Prevents Breakthrough COVID-19 Infections in Immunosuppressed Population: 6-Month Prospective Study

et al. 2023

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Background: Persons with neuroinflammatory diseases (pwNID) treated with potent immunosuppressives are at risk of severe COVID-19 outcomes and reduced vaccine seroconversion. We aimed at determining the real-world efficacy of tixagevimab and cilgavimab (Evusheld™) in immunosuppressed pwNID in preventing breakthrough COVID-19 infections. Methods: 31 immunosuppressed pwNID were followed for 6 months after administration of tixagevimab and cilgavimab as a prophylactic COVID-19 medication (January 2022–July 2022). Only pwNID treated with anti-CD20 monoclonal antibodies and sphingosine-1-phosphate modulators were considered eligible for the study. A control group of 126 immunosuppressed pwNID (38 seropositive and 88 seronegative after SARS-CoV-2 vaccination) were included. Breakthrough COVID-19 infections rate and their severity was determined over the follow-up. Results: The pwNID treated with tixagevimab and cilgavimab had more comorbidities when compared with the total and seronegative pwNID control group (54.8% vs. 30.2% vs. 27.3%, p = 0.02 and p = 0.005, respectively). After a 6-month follow-up, significantly lower numbers of pwNID treated with tixagevimab and cilgavimab had breakthrough COVID-19 when compared with the control pwNID group (6.5% vs. 34.1%, p = 0.002) and seronegative control pwNID group (6.5% vs. 38.6%, p < 0.001). All COVID-19 infections in Evusheld-treated pwNID were mild, whereas 9/43 COVID-19 infections in the control group were moderate/severe. No side effects to tixagevimab and cilgavimab were recorded. Conclusion: In pwNID treated with immunosuppressive therapies, tixagevimab and cilgavimab (Evusheld™) significantly reduced the numbers and severity of breakthrough COVID-19 infections during the Omicron (BA.2–BA.5 variants) wave.

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Section: Discussionmentioning

confidence: 99%

Tixagevimab and Cilgavimab (Evusheld™) Prophylaxis Prevents Breakthrough COVID-19 Infections in Immunosuppressed Population: 6-Month Prospective Study

et al. 2023

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“…Real-world evidence (RWE) consistently demonstrates the benefit of Tixagevimab/Cilgavimab in data from immunocompromised populations (see Table 2 ) [ 23 , 24 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 ]. Pre-exposure prophylaxis with Tixagevimab/Cilgavimab was associated with a lower risk of SARS-CoV-2 infections and better outcomes during the Omicron surge in the real world, most data deriving from the BA.2 lineage.…”

Section: Prophylaxismentioning

confidence: 95%

“…The median days from Tixagevimab/Cilgavimab administration to non-COVID-19-related hospitalization and death were 30 (IQR 17, 55) and 53 (IQR 18, 91), respectively [ 53 ]. Similarly, in a series of 161 recipients of allogeneic hematopoietic stem-cell transplants receiving Tixagevimab/Cilgavimab, 86.3% remained uninfected, while no hospitalizations or deaths were reported [ 61 ].…”

Section: Prophylaxismentioning

confidence: 99%

Tixagevimab/Cilgavimab in SARS-CoV-2 Prophylaxis and Therapy: A Comprehensive Review of Clinical Experience

Akinosoglou

Rigopoulos

Kaiafa

et al. 2022

Viruses

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Effective treatments and vaccines against COVID-19 used in clinical practice have made a positive impact on controlling the spread of the pandemic, where they are available. Nevertheless, even if fully vaccinated, immunocompromised patients still remain at high risk of adverse outcomes. This has driven the largely expanding field of monoclonal antibodies, with variable results. Tixagevimab/Cilgavimab (AZD7442), a long-acting antibody combination that inhibits the attachment of the SARS-CoV-2 spike protein to the surface of cells, has proved promising in reducing the incidence of symptomatic COVID-19 or death in high-risk individuals without major adverse events when given as prophylaxis, as well as early treatment. Real-world data confirm the antibody combination’s prophylaxis efficacy in lowering the incidence, hospitalization, and mortality associated with COVID-19 in solid organ transplant recipients, patients with immune-mediated inflammatory diseases and hematological malignancies, and patients in B-cell-depleting therapies. Data suggest a difference in neutralization efficiency between the SARS-CoV-2 subtypes in favor of the BA.2 over the BA.1. In treating COVID-19, AZD7442 showed a significant reduction in severe COVID-19 cases and mortality when given early in the course of disease, and within 5 days of symptom onset, without being associated with severe adverse events, even when it is used in addition to standard care. The possibility of the development of spike-protein mutations that resist monoclonal antibodies has been reported; therefore, increased vigilance is required in view of the evolving variants. AZD7442 may be a powerful ally in preventing COVID-19 and the mortality associated with it in high-risk individuals. Further research is required to include more high-risk groups and assess the concerns limiting its use, along the SARS-CoV-2 evolutionary trajectory.

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“…Four drugs have been approved by the European Medicines Agency (EMA), based on significant results for prevention of progression to severe disease or death in pauci-symptomatic high-risk patients: casirivimab/imdevimab (124,125), sotrovimab (126), regdanvimab (127), tixagevimab/cilgavimab (128). Although the first three treatments are only indicated for curative treatment, tixagevimab/ cilgavimab, has also been approved as prophylactic treatment (at a dose of 300mg/300mg every 6 months), based on the PREVENT study (129), reporting a 77% reduction in the risk of infection at 3 months, with a benefit confirmed in other studies (130)(131)(132), including one with an allo-HSCT population (133). The emergence of new variants has rapidly led to a loss of efficacy (134-141) (particularly with respect to BA.5, currently the most represented variant), leaving only one indication among all these treatments for tixagevimab/cilgavimab in case of contraindication to antiviral treatment, or in case of infection with an old sensitive variant, according to current French recommendations (142).…”

Section: Treatment Of Covid-19 In Allo-hsct Recipientsmentioning

confidence: 99%

Allogeneic hematopoietic stem cell transplantation in the COVID-19 era

Bordat

Maury²,

Leclerc³

2023

Front. Immunol.

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Allogeneic hematopoietic stem-cell transplantation (allo-HSCT) recipients are especially vulnerable to coronavirus disease 19 (COVID-19), because of their profound immunodeficiency. Indeed, the first pandemic wave was marked by a high mortality rate in this population. Factors increasing immunodepression such as older age, immunosuppressive treatments or a short delay between transplant and infection appear to worsen the prognosis. Many changes in clinical practice had to be implemented in order to limit this risk, including postponing of transplant for non-malignant diseases, preference for local rather than international donations and for peripheral blood as stem cell source, and the widespread use of cryopreservation. The great revolution in the COVID-19 pandemic came from the development of mRNA vaccines that have shown to be able to prevent severe forms of the disease. More than 75% of allo-HSCT recipients develop seroconversion after 2 doses of vaccine. Multiple studies have identified lymphopenia, exposure to immunosuppressive or anti-CD20 therapies, and a short post-transplant period as factors associated with a poor response to vaccination. The use of repeated injections of the vaccine, including a third dose, not only improves the seroconversion rate but also intensifies the immune response, both in B cells and T cells. Vaccines are an effective and well-tolerated method in this high-risk population. Some studies investigated the possibility of immune protection being transferred from a vaccinated donor to a recipient, with encouraging initial results. However, dynamic mutations and immune escape of the virus can lead to breakthrough infections with new variants in vaccinated individuals and still represent a threat of severe disease in allo-HSCT recipients. New challenges include the need to adapt vaccine protection to emerging variants.

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Pre-exposure prophylaxis with tixagevimab/cilgavimab (AZD7442) prevents severe SARS-CoV-2 infection in recipients of allogeneic hematopoietic stem cell transplantation during the Omicron wave: a multicentric retrospective study of SFGM-TC

Cited by 29 publications

References 9 publications

Tixagevimab and Cilgavimab (Evusheld™) Prophylaxis Prevents Breakthrough COVID-19 Infections in Immunosuppressed Population: 6-Month Prospective Study

Tixagevimab and Cilgavimab (Evusheld™) Prophylaxis Prevents Breakthrough COVID-19 Infections in Immunosuppressed Population: 6-Month Prospective Study

Tixagevimab/Cilgavimab in SARS-CoV-2 Prophylaxis and Therapy: A Comprehensive Review of Clinical Experience

Allogeneic hematopoietic stem cell transplantation in the COVID-19 era

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