The EVOLVE Study: A Prospective, Observational Study to Evaluate Patient-centered Outcomes Over 2 Years of Treatment With Tezepelumab in Real-life Clinical Practice in Greece
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 155
- 试验地点
- 8
- 主要终点
- Change in the ACQ-6 score at baseline and up to 104 weeks post-index
研究概览
简要总结
Tezepelumab is a first-in-class human monoclonal antibody for uncontrolled severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), a key epithelial cytokine inducing both Type 2 and non- Type 2 inflammatory pathways. Considering the recent addition of tezepelumab to the severe asthma therapeutic arsenal, there is a need for real-world evidence that can inform treatment-decision making in clinical practice and support regulatory decisions.
EVOLVE is a prospective, observational study designed to generate real-world evidence on patient-reported outcomes of treatment with tezepelumab, assessing the effectiveness over a 2-year period in routine care settings in Greece.
The study plans to enroll 150 adult patients at an allocation ratio of: i) 70 percent Type 2-high/30 percent Type 2-low, and ii) 80 percent biologic naïve/20 percent switching from a prior biologic. Eligible patients must be newly prescribed tezepelumab according to the approved label.
Primary data will be collected at enrollment and 4, 12, 24, 52, 72 and 104 weeks after treatment initiation through visits as per the standard clinical practice in various healthcare settings (20-25 sites) across the country.
The primary objective is to describe the patient-reported asthma symptom control using the Asthma Control Questionnaire (ACQ-6) at baseline and up to 104 weeks post-index. Secondary and exploratory objectives include assessment of quality of life, lung function, exacerbation rate, corticosteroid use, health-care utilization. Novel composite endpoints will also be evaluated such as early clinically important improvement, disease stability, super-response and clinical remission at 2 years, which in the era of precision biologics, have the potential to shift treatment paradigms toward a treat-to-target approach.
Findings of EVOLVE are expected to not only complement evidence obtained from clinical trials, but also to provide valuable insights into the long-term durability of treatment benefits and sustainability of clinical response under pragmatic clinical conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients aged 12 years or older at the time of signing the informed consent/assent form.
- •Patients who have been prescribed but not yet initiated treatment with tezepelumab according to the label and local market reimbursement criteria.
- •Diagnosis of asthma for at least 52 weeks prior to enrolment date and symptoms confirmed by the Investigator not to be due to alternative diagnoses.
- •Receipt of at least one prescription of high-dose Inhaled Corticosteroids (ICS) (according to the Global Initiative for Asthma 2024) during the 52 weeks prior to enrolment date.
- •Use of additional asthma maintenance controller medication(s) in addition to ICS either as free- or fixed-drug combination for at least 52 weeks prior to enrolment date.
- •Documented history of at least 1 asthma exacerbation during the 52 weeks prior to enrolment date.
- •Asthma Control Questionnaire (ACQ-6) score ≥1.5 (indicating inadequate asthma symptom control) at enrolment.
- •Availability of at least one Blood Eosinophil Count (BEC) measurement (in medical records) in the 52-week period prior to enrolment date.
- •Availability of participants' medical records for asthma exacerbations and unscheduled Health Care Resource Utilization (HCRU) for the 52 weeks prior to enrolment date.
- •Patients are able to understand and complete the Patient-Reported Outcome (PROs).
- •Provision of signed and dated written informed consent/assent (as applicable).
排除标准
- •Any contraindication to tezepelumab as per the approved product label or in the opinion of the Investigator.
- •Concurrent or recent (<30 days before the index date) treatment with biologics for asthma, with the exception of stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment).
- •Participation in an observational study that might, in the Investigator's opinion, influence the assessment for the current study, or participation in an interventional clinical trial in the last 3 months.
- •Currently pregnant (or intention to become pregnant) or lactating women.
结局指标
主要结局
Change in the ACQ-6 score at baseline and up to 104 weeks post-index
时间窗: Before treatment initiation and at Weeks 4, 12, 24, 52, 72, 104 after treatment initiation
Asthma Control Questionnaire-6 (ACQ-6) score at different timepoints Change in ACQ-6 score from baseline Proportion of patients with ACQ-6 response (i.e., achieving the Minimum Clinically Important Difference (MCID) of ≥0.5 reduction in score from baseline) Proportion of patients with major improvement in asthma control (defined as decrease in ACQ-6 score ≥1 point \[i.e., 2xMCID\] from baseline) Proportion of patients with well-controlled asthma (ACQ-6 score ≤ 0.75) Proportion of patients with ACQ-6 score in categories 0.75 to \<1.5 and ≥1.5 Time to ACQ-6 score response
次要结局
- Change in asthma-specific HRQoL using the SGRQ at baseline and up to 52 weeks post-index(Before treatment initiation and at Weeks 24 and 52 after treatment initiation)
- Change in FEV1 (forced expiratory volume in 1 second) at baseline and up to 104 weeks post-index(Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation)
- Change in FVC (Forced Vital Capacity) at baseline and up to 104 weeks post-index(Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation)
- Change in pre-BD FEF25-75 (Forced Expiratory Flow) at baseline and up to 104 weeks post-index(Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation)
- Change in lung function at baseline and up to 104 weeks post-index(Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation)
- Change in asthma exacerbations in the 52 and 104 weeks post-index(During 52 weeks before treatment initiation and 52 and 104 weeks after treatment initiation)
- Proportion of patients with asthma exacerbations in the 52 and 104 weeks post-index(During 52 weeks before treatment initiation and 52 and 104 weeks after treatment initiation)
- Time to first asthma exacerbation from index date(Until 104 weeks after treatment initiation)
- Proportion of patients with asthma-related Systemic Corticosteroids (SCS) and Inhaled Corticosteroids (ICS) use during the 52 week-period pre- and post-index(During 52 weeks before treatment initiation and 52 weeks after treatment initiation)
- Change in asthma-related Systemic Corticosteroids (SCS) and Inhaled Corticosteroids (ICS) use during the 52 week-period pre- and post-index(During 52 weeks before treatment initiation and 52 weeks after treatment initiation)
- Time to earliest Systemic Corticosteroids (SCS) use from index date(During 52 weeks before treatment initiation and 52 weeks after treatment initiation)
- Change in rate and duration of asthma-related HCRU for the 52 weeks pre- and post-index(During 52 weeks before treatment initiation and during 52 and 104 weeks after treatment initiation)
- Changes in proportion of participants achieving (a) asthma disease stability or (b) partial stability up to 104 weeks post-index(At weeks 4, 12, 24, 52, 72 and 104 after treatment initiation)
- Duration of therapy at 52 and 104 weeks post-index(At Week 52 and 104 after treatment initiation or at the moment of treatment discontinuation through study completion, an average of 2 years (104 weeks))
- Discontinuation rate at 52 and 104 weeks post-index(At Week 52 and 104 after treatment initiation or at the moment of treatment discontinuation through study completion, an average of 2 years (104 weeks))