Background

Patients 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.

Objective

This analysis further assessed the impact of tezepelumab on patient-reported outcomes (PROs) in PATHWAY.

Methods

Adults 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.

Results

Overall, 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.

Conclusion

Tezepelumab 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.

中文翻译：

---

Tezepelumab可改善PATHWAY中严重，无法控制的哮喘患者的患者报告结局

背景

患有严重不受控制的哮喘的患者会频繁发作和住院，导致与健康相关的生活质量较差。在2b阶段PATHWAY研究（NCT02054130）中，与安慰剂相比，tezepelumab可使病情加重最多减少71％，并改善了肺功能，哮喘控制和健康相关的生活质量。

目的

该分析进一步评估了tezepelumab对PATHWAY中患者报告的结局（PRO）的影响。

方法

患有严重，不受控制的哮喘的成年人被随机分配至皮下tezepelumab（每4周70 mg，每4周210 mg或每2周280 mg）或安慰剂52周。使用哮喘控制调查表-6（ACQ-6）和哮喘生活质量调查表（标准）对12岁或12岁以上患者（AQLQ [S] +12）评估PRO。确定了tezepelumab和安慰剂组中反应良好的患者的比例（定义为ACQ-6或AQLQ（S）+12得分提高≥0.5）和哮喘得到良好控制，部分控制或不受控制的患者。哮喘每日日记调查表用于评估总体症状严重程度的变化。

结果

总体上，有550名患者被随机分组​​。接受tezepelumab治疗的患者中，分别有多达82％和77％的患者为ACQ-6和AQLQ（S）+12应答者，而接受安慰剂治疗的患者分别为70％和64％。tezepelumab治疗组哮喘控制或部分控制的患者比例高于安慰剂组。此外，tezepelumab改善了总体症状严重程度。

结论

如ACZE-6和AQLQ（S）+12应答者比例更高以及tezepelumab剂量组的症状严重程度改善，表明Tezepelumab治疗可改善PROs优于安慰剂。这些数据进一步支持了tezepelumab对严重，无法控制的哮喘患者的益处。