Efficacy and Safety of Tezepelumab in Adults With Severe, Uncontrolled Asthma in Asia: Results From the Phase 3 DIRECTION Study

BACKGROUND: Tezepelumab, a human monoclonal antibody that blocks thymic stromal lymphopoietin, reduced the annualized asthma exacerbation rate (AAER) and improved lung function, asthma control, and health-related quality of life (HRQoL) in patients with severe, uncontrolled asthma (SUA) in the global, phase 3 NAVIGATOR study (NCT03347279). OBJECTIVE: DIRECTION was a phase 3, multicenter, double-blind study that assessed the efficacy and safety of tezepelumab in adults with SUA in China, the Philippines, and the Republic of Korea. METHODS: ) and Asthma Control Questionnaire-6 (ACQ-6), Asthma Quality of Life Questionnaire (standardized) for patients 12 years and older (AQLQ[S]+12), and Asthma Symptom Diary (ASD) scores. Safety was also assessed. RESULTS: (least-squares mean difference: 0.24 L [95% CI: 0.16, 0.32]) and ACQ-6, AQLQ(S)+12, and ASD scores at week 52 versus placebo (all P ≤ .001). No new safety concerns were identified. CONCLUSIONS: Tezepelumab reduced exacerbations and improved lung function, asthma control, and HRQoL in Asian patients with SUA, consistent with prior study findings.