Post-hoc Analyses of Lebrikizumab Phase 3 Trials (LAVOLTA I and II): Enhanced Efficacy in Patients With Prior Exacerbations and Elevated Baseline FENO or Blood Eosinophilia

LAVOLTA I and II (LI&II) were duplicate placebo-controlled Phase 3 trials of lebrikizumab (LEB) in moderate-to-severe asthma that enrolled patients irrespective of asthma exacerbation history, baseline blood eosinophilia, or FENO. Two dose groups were studied: 125 mg and 37.5 mg Q4W. Primary endpoint was adjusted exacerbation rate ratio (AERR) in “Type 2 (T2) biomarker positive” patients (defined as periostin >50 ng/mL or blood eosinophils >300 cells/μL). LI&II failed to show consistently significant results in AERR or a dose response.