Methods: We analyzed baseline distribution of key Type 2 biomarkers in pooled data from three Phase 2 lebrikizumab trials in 659 moderate-to-severe asthma patients (NCT00930163/NCT01545440/NCT01545453). Key eligibility criteria included treatment with ICS (200–2000 µg/day fluticasone propionate or equivalent) and ≥1 additional controller, uncontrolled asthma (ACQ-5 ≥1.5), pre-bronchodilator FEV1 40–80% predicted and ≥12% FEV1 reversibility. Patients were not excluded based on history of exacerbations or biomarker values.
Results: The key Type 2 biomarkers and cut-off values assessed in this post hoc analysis were serum periostin (≥50 ng/mL), blood eosinophils (≥300 cells/µL) and FeNO (≥30 ppb). Based on these cut-offs, 46%, 35% and 33% of patients were high for periostin, blood eosinophils and FeNO, respectively. There were 68% patients high for any Type 2 biomarker, 23% high for any two, and 11% high for all three. Overall, 18% of asthma patients were high for serum periostin only, 9% high for blood eosinophils only and 7% high for FeNO only.
Conclusions: In a pooled analysis of three trials designed to evaluate the effects of lebrikizumab treatment in moderate-to-severe uncontrolled asthma, 68% of patients had evidence of Type 2 inflammation using the specified cut-off values for periostin, blood eosinophils and FeNO.