Abstract
BackgroundPatients with severe, uncontrolled asthma experience frequent exacerbations and hospitalization, leading to poor health-related quality of life. In the phase 2b PATHWAY study (NCT02054130), tezepelumab reduced exacerbations by up to 71% and improved lung function, asthma control, and health-related quality of life vs placebo. ObjectiveThis analysis further assessed the impact of tezepelumab on patient-reported outcomes (PROs) in PATHWAY. MethodsAdults with severe, uncontrolled asthma were randomized to subcutaneous tezepelumab (70 mg every 4 weeks, 210 mg every 4 weeks, or 280 mg every 2 weeks) or placebo for 52 weeks. PROs were assessed using the asthma control questionnaire–6 (ACQ-6) and the asthma quality of life questionnaire (standardized) for patients aged 12 years or older (AQLQ[S]+12). The proportions of responders (defined by improvements of ≥0.5 in ACQ-6 or AQLQ(S)+12 scores) and patients whose asthma was well-controlled, partially-controlled, or uncontrolled in the tezepelumab and placebo groups were identified. The Asthma Daily Diary questionnaire was used to assess changes in overall symptom severity. ResultsOverall, 550 patients were randomized. Up to 82% and 77% of tezepelumab-treated patients were ACQ-6 and AQLQ(S)+12 responders, respectively, compared with 70% and 64% of placebo-treated patients, respectively. The proportions of patients with well-controlled or partially-controlled asthma were higher in the tezepelumab-treated group than in the placebo group. In addition, tezepelumab improved the overall symptom severity. ConclusionTezepelumab treatment improved PROs vs placebo, as indicated by the higher proportion of ACQ-6 and AQLQ(S)+12 responders and improvements in symptom severity in the tezepelumab dose groups. These data further support the benefits of tezepelumab in patients with severe, uncontrolled asthma.
Highlights
10% of patients with asthma in the USA have severe asthma.[1]
In a previous analysis of PATHWAY, patients treated with tezepelumab had greater improvements from baseline in the Asthma Control Questionnaire-6 (ACQ-6) and Asthma Quality of Life Questionnaire for patients aged 12 years or older (AQLQ[S]þ12) scores than those treated with placebo.[13]
In a previous analysis of PATHWAY phase 2b study data, tezepelumab improved patient-reported outcomes (PROs) compared with placebo in patients with severe, uncontrolled asthma, as demonstrated by improvements from baseline to end of treatment in ACQ-6 and AQLQ(S)þ12 scores
Summary
10% of patients with asthma in the USA have severe asthma.[1]. These patients experience recurrent exacerbations[2,3,4] and poorly controlled symptoms despite the standard-ofcare treatment,[1,5,6,7] which contributes to poor health-related quality of life (HRQoL).[5,7] New biologic therapies that have been developed for the treatment of severe asthma have limited efficacy in some patients.[8,9,10] for these patients, an unmet need remains for effective therapies to reduce asthma symptoms, prevent exacerbations, and improve HRQoL.[11]Tezepelumab is a human monoclonal antibody (immunoglobulin G2l) that binds to thymic stromal lymphopoietin (TSLP), blocking it from interacting with its heterodimeric receptor.[12,13] TSLP is an epithelial-derived cytokine and is a key regulator of many downstream inflammatory pathways involved in response to airborne particles such as viruses and allergens.[14,15,16] Expression of TSLP is increased in the airways of patients with asthma and correlates with disease severity.[17,18,19] In the PATHWAY phase 2b trial (ClinicalTrials.gov identifier: NCT02054130), tezepelumab significantly reduced asthma exacerbations over 52 weeks by up to 71% compared with placebo in patients with severe, uncontrolled asthma. The proportions of responders (defined by improvements of !0.5 in ACQ-6 or AQLQ(S)þ12 scores) and patients whose asthma was well-controlled, partially-controlled, or uncontrolled in the tezepelumab and placebo groups were identified. Conclusion: Tezepelumab treatment improved PROs vs placebo, as indicated by the higher proportion of ACQ-6 and AQLQ(S)þ12 responders and improvements in symptom severity in the tezepelumab dose groups. These data further support the benefits of tezepelumab in patients with severe, uncontrolled asthma
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