Study: Evusheld Offers Significant Prevention Against Severe COVID-19 Disease, Death – Pharmacy Times

Analysis shows that individuals who received treatment within 3 days of symptom onset with tixagevimab and cilgavimab reduced their risk by 88% compared with the placebo.

Detailed results from the TACKLE phase 3 outpatient treatment trial showed that tixagevimab and cilgavimab (Evusheld; AstraZeneca) provided clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared with the placebo, AstraZeneca said in a statement.

Additionally, the findings, published in The Lancet Respiratory Medicine, showed that treatment with tixagevimab and cilgavimab earlier in the disease course led to more favorable outcomes.

“Despite the success of vaccines, many individuals such as older adults, individuals with co-morbidities and those who are immunocompromised, remain at risk for poor outcomes from severe COVID-19. Additional options are needed to prevent disease progression and reduce the burden on health care systems, especially with the continued emergence of new variants,” Hugh Montgomery, MD, professor of Intensive Care Medicine at University College London, United Kingdom, said in the statement.

“The TACKLE results show that 1 intramuscular dose of [tixagevimab and cilgavimab] can prevent these individuals from progressing to severe COVID-19, with earlier treatment leading to even better results,” he said.

The TACKLE study was conducted in individuals with mild to moderate COVID-19 who were symptomatic for 7 days or fewer and were not hospitalized. Investigators reported that 90% of the individuals in the study were at high risk of progression to severe COVID-19 because of age or comorbidities.

In the study, a single 600-mg intramuscular dose of tixagevimab and cilgavimab significantly reduced the relative risk of progressing to severe COVID-19 or death, from any cause, by 50% through day 29 compared with the placebo in individuals with mild-to-moderate COVID-19 who were symptomatic for 7 days or fewer and not hospitalized, which was the primary endpoint of the study.

In pre-specified analyses of individuals who received treatment within 3 days of symptom onset, tixagevimab and cilgavimab reduced the risk of developing severe COVID-19 or death, from any cause, by 88% compared with the placebo.

Additionally, the risk reduction was 67% when individuals received tixagevimab and cilgavimab within 5 days of symptom onset.

Tixagevimab and cilgavimab also reduced the risk of respiratory failure, a secondary endpoint by 72%, with 3 individuals who received tixagevimab and cilgavimab compared with 11 individuals taking the placebo requiring measures, such as extracorporeal membrane oxygenation or mechanical ventilation.

“These results published in The Lancet Respiratory Medicine add to the growing evidence supporting the use of [tixagevimab and cilgavimab] to help patients who most need additional protection against COVID-19. We are discussing the TACKLE data with regulatory authorities and continue to progress submissions in both treatment and prophylaxis indications to help combat COVID-19 on all fronts,” Mene Pangalos, PHD, executive vice president of BioPharmaceuticals R&D at AstraZeneca, said in the statement.

Tixagevimab and cilgavimab was generally well-tolerated in the trial with adverse events (AEs) occurring more frequently in the placebo arm than the tixagevimab and cilgavimab arm at 36% and 29%, respectively.

The most common AE was COVID-19 pneumonia, occurring in 11% of individuals in the placebo arm and 6% in the tixagevimab and cilgavimab arm. Serious AEs occurred in 12% and 7%, respectively, and there were 6 deaths and 3 deaths, respectively.

Reference

Evusheld significantly prevented COVID-19 disease progression or death in TACKLE Phase 3 treatment trial. AstraZeneca. News release. June 8, 2022. Accessed June 10, 2022. https://www.astrazeneca.com/media-centre/press-releases/2022/evusheld-significantly-prevented-covid-19-disease-progression-or-death-in-tackle-phase-iii-treatment-trial.html

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