Lenzilumab in Hospitalized Black/African-American COVID-19 Patients: Live-Air Phase 3 Study Results
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Pharmacology, Infection, Worldwide Data, 2022
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BACKGROUND: Black/African Americans (B/AA) are twice as likely as Whites to develop COVID-19, possibly due to disparities in healthcare access and genetics. Mutations in the angiotensin converting enzyme gene enabling greater SARS-CoV-2 replication may be overexpressed in B/AAs leading to increased viral load, morbidity, hospitalizations, and mortality. The hyperinflammatory cytokine storm accompanying SARS-CoV-2 infection is mediated by GM-CSF releasing downstream inflammatory chemokines, cytokines, and inflammatory markers including C-reactive protein (CRP), predictive of clinical worsening. This analysis of LIVE-AIR explored the efficacy of lenzilumab in its B/AA population. METHODS: LIVE-AIR was a randomized, double-blind, placebo-controlled trial of 479 (mITT population) hospitalized COVID-19. Patients, >18 years old with oxygen saturation ≤94% on room air or requiring supplemental oxygen (low-flow or high-flow), but not invasive mechanical ventilation, were randomized to receive lenzilumab (1800 mg, n=236) or placebo (n=243) via three IV infusions, every 8 hours, within 12 hours of randomization. A secondary analysis of the primary endpoint, survival without ventilation (SWOV), by race/ethnicity and baseline CRP level was assessed at Day 28. RESULTS: Participants were racially and ethnically diverse: 3.1% Asians, 14.8% B/AA, 38.6% Hispanic/Latino. The likelihood of SWOV was significantly improved by lenzilumab across races and ethnicities compared with placebo (HR: 1.54; 95% CI: 1.02, 2.32; p=0.0403; Nf479) and in patients with baseline CRP < 150 mg/L, < 85 years of age (HR 3.04; 1.68, 5.51; p=0.0003; n=337). The likelihood of SWOV in B/AAs trended higher than the overall population (HR: 2.68; 0.89-8.12; p=0.0811; n=71) and was significantly and disproportionately improved in those with baseline CRP < 150 mg/L (HR: 8.96; 1.09-73.55; p=0.0412; n=51). Serious adverse events were similar across treatment groups. CONCLUSION: In LIVE-AIR, with a B/AA representation comparable to the US population and usually under-represented in trials, lenzilumab improved the likelihood of SWOV across races and ethnicities of COVID-19 patients; however, B/AA with baseline CRP < 150 mg/L exhibited a markedly greater improvement. Biological, genetic, and social factors contributing to these differences requires further investigation.
Meta Tag
Content Type Presentation
Knowledge Area Pharmacology
Knowledge Area Infection
Knowledge Area Worldwide Data
Knowledge Level Advanced
Membership Level Select
Tag Pharmacokinetics Pharmacodynamics
Tag Epidemiology Outcomes
Tag COVID-19
Year 2022
clinical trial
C-reactive protein


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