Background

About, 20% of pts with severe uncontrolled asthma (SUA) were ineligible for approved biologics¹ and ~60% of biologic-treated pts remained uncontrolled or sub-optimally controlled². Tezepelumab, a thymic stromal lymphopoietin (TSLP)-blocking monoclonal antibody, reduced exacerbations and improved lung function, asthma control and health-related quality of life (HRQoL) vs placebo in a broad population of pts with SUA in randomised controlled trials.

Objective

ASCENT will assess the impact of tezepelumab on asthma outcomes, with a focus on patient-reported outcomes (PROs), in a real-world setting.

Methods

ASCENT is a prospective, non-comparative, observational real-world evidence study. Approximately 400 pts with SUA (>12yr) treated with tezepelumab as determined by routine clinical care will be enrolled across 8 European countries and Canada. The primary objective is to describe patient-reported asthma symptom control using the asthma control questionnaire at baseline and first 12-mo of treatment. Key secondary objectives include improvements in HRQoL, lung function, exacerbations, asthma medication use, asthma-related healthcare utilisation and disease stability. Exploratory objectives differ by country, but focus on clinical remission, asthma triggers, SNOT-22, work productivity, sleep and physical activity using wearable devices.

Conclusion

ASCENT aims to demonstrate the effectiveness of tezepelumab in patients with SUA in a real-world clinical setting with a focus on PROs.

References

1. Heaney LG et al. Chest. 2021;160:814-30.

2. Reibman J et al. Ann Allergy, Asthma Immunol. 2021;127:318-325.e2.