Early and continued asthma control up to week 24 in patients with severe, uncontrolled asthma treated with tezepelumab: Initial results of the real-world ASCENT study.

INTRODUCTION: Tezepelumab has demonstrated efficacy in patients with severe, uncontrolled asthma in randomized controlled trials (RCTs). Real-world studies assessing patient-reported outcomes are required to complement RCT findings. METHODS: ASCENT is an ongoing, multi-country, single-arm, prospective, real-world study assessing asthma symptom control in participants (≥12 years old) with severe, uncontrolled asthma initiating tezepelumab as routine standard of care in Europe and Canada. This interim analysis assessed changes from baseline in Asthma Control Questionnaire-6 (ACQ-6) score, St George's Respiratory Questionnaire (SGRQ) total score, and pre-bronchodilator forced expiratory volume in 1 second (FEV1) at weeks 4, 12, and 24, and the annualized asthma exacerbation rate (AAER) in the 52-week baseline and 24-week follow-up periods. RESULTS: Overall, 211 participants were included in this analysis. ACQ-6 and SGRQ total scores improved from baseline to week 4 (least-squares mean [95% CI] change: -0.99 [-1.13, -0.84] and -13.2 [-15.6, -10.8], respectively) and further improved to week 24 (-1.28 [-1.44, -1.12] and -19.8 [-22.6, -17.0], respectively). AAER decreased by 65% (95% CI: 55, 73) between baseline (1.75) and follow-up (0.61) periods. Least-squares mean changes from baseline in pre-bronchodilator FEV1 at weeks 4 and 24 were 0.09 L (0.03, 0.14) and 0.12 L (0.06, 0.18), respectively. These changes were observed across asthma phenotypes and biomarker levels. CONCLUSION: Patients with severe, uncontrolled asthma treated with tezepelumab had clinically meaningful improvements in asthma control, health-related quality of life, lung function, and exacerbations as early as week 4 through to week 24, irrespective of asthma phenotype. CLINICAL TRIAL NUMBER: NCT05677139.