EVOLVE Study: The Real-life Clinical Practice With Tezepelumab in Greece

N/AActive Not RecruitingNCT06724575

AstraZeneca155 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

155

Conditions

Asthma

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Change in the ACQ-6 score at baseline and up to 104 weeks post-index

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

Time frame: Before treatment initiation and at Weeks 4, 12, 24, 52, 72, 104 after treatment initiation

Secondary Outcomes

Change in asthma-specific HRQoL using the SGRQ at baseline and up to 52 weeks post-index

St. George's Respiratory Questionnaire (SGRQ) total and component scores at different timepoints Change in SGRQ total and component scores from baseline Proportion of patients with SGRQ response (≥4-point reduction in total score from baseline)

Time frame: 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

To describe the pre- and post-BD (Bronchodilation) FEV1, as well as the changes from baseline in pre- and post-BD FEV1 in patients receiving Tezepelumab.

Time frame: 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

To describe the pre- and post-BD (Bronchodilation) FVC, as well as the changes from baseline in pre- and post-BD FVC in patients receiving Tezepelumab.

Time frame: 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

To assess the pre-BD (Bronchodilation) FEF25-75, as well as the changes from baseline in pre-BD FEF25-75 in patients receiving Tezepelumab

Time frame: 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

To evaluate the proportion of pre- and post-BD (Bronchodilation) FEV1 responders (≥5 percent or ≥100 mL improvement from baseline)

Time frame: 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

To describe (a) Annualised Asthma Exacerbation Rate (AAER), (b) change in AAER from the 52 week period pre-index to the 52- and 104- week period post-index and (c) change in AAER associated with hospitalization or ED visit from the 52 week period pre-index to the 52- and 104- week period post-index

Time frame: 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

To assess the (a) proportion of patients with asthma exacerbations after 52 and 104 weeks of treatment with Tezepelumab, (b) the proportion of patients who completed the 52 week period post-index with any reduction, ≥50 percent, and 100 percent reduction in total number of asthma exacerbations compared with baseline period, and (c) the proportion of patients with asthma exacerbations resulting in hospitalization, and number of hospital days owing to exacerbations (total and averaged per patient) in the 52 week periods pre- and post-index

Time frame: During 52 weeks before treatment initiation and 52 and 104 weeks after treatment initiation

Time to first asthma exacerbation from index date

To describe the time to first asthma exacerbation from index date of treatment with Tezepelumab

Time frame: 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

To assess (a) the proportion of patients with any SCS or ICS use, (b) the proportion of patients who completed the 52 week period post-index with any reduction, ≥25 percent, ≥50 percent ≥75 percent and 100 percent reduction in SCS cumulative dose (in prednisone equivalent dose) compared with baseline period, (c) the proportion of patients who completed the 52 week period post-index with any reduction, ≥50 percent (medium dose) and ≥75 percent (low dose) reduction in ICS dose compared with baseline period, (d) the proportion of patients requiring long-term (\>30 consecutive days) SCS use, and the proportion of patients requiring long-term (\>30 consecutive days) ICS use.

Time frame: 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

To evaluate the change in cumulative annualized SCS and ICS dose through the 52 week periods pre- and post-index

Time frame: During 52 weeks before treatment initiation and 52 weeks after treatment initiation

Time to earliest Systemic Corticosteroids (SCS) use from index date

To describe the time to earliest SCS use from index date among patients that used SCS

Time frame: 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

Number and proportion of patients with any asthma-related Healthcare Resource Utilization (HCRU) and type of HCRU \[i.e., hospitalisations/ Emergency Department (ED) visits (without hospitalisation)/unscheduled outpatient or physician visits\] Annualized rate of (a) asthma-related visits leading to hospitalisation, (b) ED visits (without hospitalisation), and (c) unscheduled outpatient or physician visits Duration (total and Intensive Care Unit Length of Stay) of asthma-related hospitalisations

Time frame: 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

To evaluate (a) the proportion of participants achieving stable disease \[all 4 criteria are met: i) Asthma Control Questionnaire-6 (ACQ-6) \< 1.5 at post-index timepoint; ii) pre-bronchodilator forced expiratory volume in one second (Pre-BD FEV1) at post-index timepoint/pre-BD FEV1 at baseline \>0.95; iii) ≥50 percent reduction in the annualized number of exacerbations in the follow-up period; iv) ≥ 50 percent reduction in oral corticosteroid (OCS) use in the follow-up period\], and (b) the proportion of participants with partial disease stability (1 criterion, 2 criteria, and 3 criteria are met)

Time frame: At weeks 4, 12, 24, 52, 72 and 104 after treatment initiation

Duration of therapy at 52 and 104 weeks post-index

To assess the duration of treatment with tezepelumab, as well as the time to tezepelumab treatment discontinuation

Time frame: 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

To evaluate (a) the rate of for tezepelumab treatment discontinuation and (b) the proportion of participants switching to other biologics for asthma. To describe also the reasons for tezepelumab treatment discontinuation, using a pre-defined checklist.

Time frame: 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)

EVOLVE Study: The Real-life Clinical Practice With Tezepelumab in Greece

Overview

Conditions

Eligibility

Locations (8)

Outcomes

Primary Outcomes

Secondary Outcomes