LAUSR

Background: Thymic stromal lymphopoietin (TSLP) is an epithelial cytokine and key regulator of inflammatory pathways including type 2 responses. Tezepelumab is a human anti-TSLP monoclonal antibody that reduces the early and late phase asthmatic responses to inhaled allergen. Objectives: To evaluate efficacy and safety of tezepelumab in patients with inadequately controlled, severe asthma. Methods: This was a 52-week randomized, double-blind, placebo-controlled study (NCT02054130). A total of 584 eligible adults with severe asthma and recurrent exacerbations were randomly assigned (1:1:1:1) to subcutaneous tezepelumab 70mg every 4 weeks (Q4W), 210mg Q4W, 280mg every 2 weeks (Q2W) or placebo Q2W. Randomization was stratified by region, blood eosinophils, and ICS dose. The primary endpoint was the annualized asthma exacerbation rate (AER) at Week 52. Results: Compared with placebo, AER reductions of 61%, 72%, and 66% were seen in 70, 210, and 280mg groups, respectively (p Conclusion: Tezepelumab was well-tolerated and effective in reducing AER and improving FEV1 and asthma control in a broad population of patients with inadequately controlled, severe asthma. Study supported by MedImmune and Amgen.