Pre-exposure prophylaxis with tixagevimab and cilgavimab (Evusheld) for COVID-19 among 1112 severely immunocompromised patients

Nguyen, Yann; Flahault, Adrien; Chavarot, Nathalie; Melenotte, Cléa; Cheminant, Morgane; Deschamps, P; Carlier, Nicolas; Lafont, Emmanuel; Thomas, M.; Flamarion, Edouard; Lebeaux, David; Charlier, Caroline; Rachline, Anne; Guérin, C.; Ratiney, Robert; Touchard, Jean; Péré, Hélène; Rozenberg, Flore; Lanternier, Fanny; Arlet, Jean‐Benoît; Avouac, Jérôme; Boussaud, Véronique; Guillemain, R.; Vignon, Marguerite; Thervet, Éric; Scemla, Anne; Weiss, Laurence; Mouthon, Luc

doi:10.1016/j.cmi.2022.07.015

Cited by 92 publications

(97 citation statements)

References 11 publications

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“…Of the 29 cases with viral sequencing from Nguyen’s paper, all the cases were found to be Omicron infections. At the time of the study, the mean weekly incidence rate in Ile-de-France was 1,669 infections in 100,000 inhabitants, whereas amongst the study population the incidence rate was 530 infections in 100,000 inhabitants 27 . Breakthrough infection rates reported across each study are summarised in Table 1.…”

Section: Resultsmentioning

confidence: 89%

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Systematic review of the clinical effectiveness of Tixagevimab/Cilgavimab for prophylaxis of COVID-19 in immunocompromised patients

Suribhatla

Starkey

Ionescu³

et al. 2022

Preprint

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Background and aims Immunocompromised patients have a reduced ability to generate antibodies after COVID-19 vaccination and are at higher risk of SARS-CoV-2 infection, complications and mortality. Tixagevimab/Cilgavimab (Evusheld) is a monoclonal antibody combination which bind to the SARS-CoV-2 spike protein, preventing the virus entering human cells. The phase III PROVENT trial reported that immunocompromised patients given Tixagevimab/Cilgavimab had a significantly reduced risk of COVID-19 infection. However, PROVENT was conducted before the SARS-CoV-2 Omicron became prevalent. This systematic review provides an updated summary of real-world clinical evidence of Tixagevimab/Cilgavimab effectiveness in immunocompromised patients. Methods Two independent reviewers conducted PubMed and medRxiv searches for the period of 01/01/2021 to 01/10/2022. Clinical studies which reported the primary outcome of breakthrough COVID-19 infections after Tixagevimab/Cilgavimab administration were included in the review. COVID-19-related hospitalisations, ITU admissions and mortality were assessed as secondary outcomes. Clinical effectiveness was determined using the case-control clinical effectiveness methodology. The GRADE tool was used to ascertain the level of certainty for the primary outcome in each study. Results 17 clinical studies were included, comprising 24,773 immunocompromised participants of whom 10,775 received Tixagevimab/Cilgavimab. Most studies reported clinical outcomes during the SARS-CoV-2 Omicron wave. Six studies compared a Tixagevimab/Cilgavimab intervention group to a control group. Overall, the clinical effectiveness of prophylactic Tixagevimab/Cilgavimab against COVID-19 breakthrough infection, hospitalisation and ITU admission were 40.47%, 69.23% and 87.89%, respectively. For prevention of all-cause and COVID-19-specifc mortality, overall clinical effectiveness was 81.29% and 86.36%, respectively. Conclusions There is a growing body of real-world evidence validating the original PROVENT phase III study regarding the clinical effectiveness of Tixagevimab/Cilgavimab as prophylaxis for immunocompromised patients, notably demonstrating effectiveness during the Omicron wave. This review demonstrates the clinical effectiveness of prophylactic Tixagevimab/Cilgavimab at reducing COVID-19 infection, hospitalisation, ITU admission and mortality for immunosuppressed individuals. It is important that ongoing larger-scale and better-controlled real world studies are initiated and evaluated to provide ongoing certainty of the clinical benefit of prophylactic antibody treatment for immunocompromised patients in the face of new variants.

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Section: Resultsmentioning

confidence: 89%

“…All of these studies demonstrated reduced rates of hospitalisation in patients receiving Tixagevimab/Cilgavimab. The rates of hospitalisations in the ten cohort studies ranged between 0-9% over a 0.5-4-month period 12,22–25,27–31 . Hospitalisation rates reported across each study are summarised in Table 2.…”

Section: Resultsmentioning

confidence: 99%

Systematic review of the clinical effectiveness of Tixagevimab/Cilgavimab for prophylaxis of COVID-19 in immunocompromised patients

Suribhatla

Starkey

Ionescu³

et al. 2022

Preprint

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“…The authorization of T/C coincided with the emergence of the Omicron variant, which resulted in previously effective monoclonal antibodies losing effectiveness. 4 5 6 7 There is limited data available on the real-world effectiveness of T/C, especially in the Omicron era. T/C requires significant resources for administration due to its EUA status and associated institutional requirements for administering it.…”

Section: Introductionmentioning

confidence: 99%

Real World Effectiveness of Tixagevimab/cilgavimab (Evusheld) in the Omicron Era

Chen

Haste

Binkin

et al. 2022

Preprint

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Background: Pre-exposure prophylaxis for COVID-19 with tixagevimab/cilgavimab (T/C) received Emergency Use Authorization (EUA) based off of results from a clinical trial conducted prior to the Omicron variant. Its clinical effectiveness has not been well described in the Omicron era. We examined the incidence of symptomatic illness and hospitalizations among T/C recipients when Omicron accounted for virtually all cases. Methods: We used the electronic medical record to identify patients who received T/C at our institution. Among these patients, we assessed for cases of symptomatic COVID-19 and associated hospitalizations before and after receiving T/C. We used chi square tests and Fishers exact p-values to examine differences between characteristics of those who got COVID before and after T/C prophylaxis. Results: Of 1295 T/C recipients, 121 (9.3%) developed symptomatic COVID-19 before receiving T/C, and 102 (7.9%) developed symptomatic disease after receiving it. Among those with infection prior to T/C, 36/121 (29.8%) were hospitalized, including 8 (6.6%) admitted to the ICU. Among those with COVID-19 after receiving T/C, 6/102 (5.9%) were hospitalized but none required ICU admission. No COVID-related deaths occurred in either group. The majority of COVID-19 cases among those infected prior to T/C treatment occurred during Omicron BA.1 surge, while the majority of cases among post-T/C recipients occurred when BA.5 was predominant. Patients infected with COVID-19 prior to receiving T/C had received fewer vaccine doses and were less likely to receive COVID-19 therapeutics compared to those with COVID-19 after having received T/C. Conclusion: We identified COVID-19 infections after T/C prophylaxis. Among persons eligible for T/C, COVID-19 illnesses occurring after T/C were less likely to require hospitalization compared to those with COVID-19 prior to T/C. In the presence of changing vaccine coverage, multiple therapies, and changing variants, the effectiveness of T/C in the Omicron era remains difficult to assess.

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“…They are also at risk of prolonged and relapsing COVID-19 disease (3). In the absence of a robust humoral vaccination response, attention has been given recently to other potential prophylactic strategies such as long-acting monoclonal antibodies against the spike (S) protein of SARS-CoV-2 (5). We hypothesised that, given the ubiquity of vaccination and/or natural infection even by 2021, immunoglobulin preparations prepared from plasma of healthy donors may now contain levels of antibody that confer some protection, reducing the imperative for other prophylaxis.…”

Section: Textmentioning

confidence: 99%

Commercial immunoglobulin products now contain neutralising antibodies against SARS-CoV-2 spike protein which are detectable in patient serum

Upasani

OʼSullivan

Moreira

et al. 2022

Preprint

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Antibody-deficient patients respond poorly to COVID-19 vaccination and are at risk of severe or prolonged infection. Prophylaxis with anti-SARS-CoV-2 monoclonal antibodies has been considered. We here demonstrate that many immunoglobulin preparations now contain neutralising anti-SARS-CoV-2 antibodies which are transmitted to patients in good concentrations, albeit with significant differences between products.

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Pre-exposure prophylaxis with tixagevimab and cilgavimab (Evusheld) for COVID-19 among 1112 severely immunocompromised patients

Cited by 92 publications

References 11 publications

Systematic review of the clinical effectiveness of Tixagevimab/Cilgavimab for prophylaxis of COVID-19 in immunocompromised patients

Systematic review of the clinical effectiveness of Tixagevimab/Cilgavimab for prophylaxis of COVID-19 in immunocompromised patients

Real World Effectiveness of Tixagevimab/cilgavimab (Evusheld) in the Omicron Era

Commercial immunoglobulin products now contain neutralising antibodies against SARS-CoV-2 spike protein which are detectable in patient serum

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