Real World Experience; An interim analysis of effectiveness of tezepelumab in patients with severe uncontrolled asthma across the UK

Abstract

Introduction and Objectives Tezepelumab is indicated in severe uncontrolled asthma (SuA) patients aged >=12 years inadequately controlled despite high-dose inhaled corticosteroids plus maintenance treatment. Clinical trials demonstrated favourable efficacy of tezepelumab; real-world data are needed to explore effectiveness. This study evaluates characteristics, treatment patterns and outcomes of adult SuA patients who received tezepelumab in the patient access programme and post-reimbursement populations. Methods A retrospective, observational, chart review is ongoing in 11 SuA UK centres. SuA patients with an index date (tezepelumab first dose) between 01/01/2023 and 31/03/2024 were included. Data were extracted from medical records. This interim analysis (N=282) describes characteristics and outcomes during baseline (52 weeks pre-index) and follow-up (52 weeks post-index), stratified by prior biologic status, biologic-naive 0 prior biologics, N=104] or biologic-experienced >=1 prior biologic, N=175]). Results At index, mean (SD) age was 51.0 (14.5) years, 66.0% were female, 98.2% had >=1 comorbidity, 43.4% (N=89) had positive atopic status. Overall, 55.5% (146/263) had a blood eosinophil count (cells/muL) during baseline of >=150.0; this was 64.4% (65/101) in biologic-naive and 50.0% (81/161) in the biologic-experienced. 62.7% and 18.6% had >=1 or >=3 prior biologics, respectively. Key outcomes are summarised in table 1. Median (IQR) forced expiratory volume in 1 second (FEV1) post-bronchodilator (ml) increased from 1965.0 (1360.0, 2560.0) to 2220.0 (1530.0, 2890.0) over follow-up (absolute change of 125.0 -20.0, 480.0]). Annualised asthma exacerbation rate (AAER) relative reduction at 52 weeks vs baseline were 49.0% overall; 63.0% and 41.0% for biologic-naive and biologic-experienced patients, respectively. In patients on maintenance oral corticosteroids (mOCS) at baseline (N=118), 43.1% reduced dose by >=50% by 52 weeks. Overall, 73.7% had a minimally important clinical difference (MCID) improvement in Asthma Control Questionnaire-6 (ACQ-6) at 52 weeks. Conclusions Interim analyses demonstrate this cohort of SuA patients receiving tezepelumab had a high burden of mOCS use and comorbidities, with approximately two-thirds failing on a previous biologic, and almost a fifth failing on >=3 biologics. Patients had marked improvements in all clinical outcomes, especially those receiving tezepelumab as their first biologic. The study is ongoing, final analyses will include approximately 350 patients. Sponsored and funded by AstraZeneca.