Asthma
Conditions
Keywords
Asthma, uncontrolled severe asthma
Brief summary
This observational study aims to collect data in clinical practice on the clinical profile of patients treated with Tezepelumab from Q1 2024 to Q1 2025 according to the approved and reimbursed indication in Italy
Detailed description
There is a current need to gain information on the clinical profile of patients eligible for treatment with Tezepelumab according to the approved and reimbursed indication in Italy. Moreover, being Tezepelumab the latest approved biologic drug for severe asthma, it is important to better understand clinical response to treatment in patients with high severe asthma burden as: patients with allergic-eosinophilic phenotype; patients with low eosinophils level; patients affected by severe asthma associated with sinonasal disease; biologic-naïve patients, as well as bio-treated patients. The present observational study aims at filling the above-mentioned knowledge gaps in the study population in terms of clinical course, disease control and clinical remission, use of healthcare resources (treatments, visits, hospitalizations), lung functions, biomarkers, and sinonasal outcomes.
Interventions
BIOLOGICALTezepelumab
Tezepelumab is indicated as an add-on maintenance treatment in adult and adolescent ≥12 years patients with severe uncontrolled asthma despite high-dose inhaled corticosteroids plus long-acting β-agonists
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
1. Adult and adolescent patients (age ≥12 years) at the Index Date (i.e., first administration of tezepelumab); 2. Patients with severe uncontrolled asthma (diagnosed according to clinician's judgment as per ERS-ATS or GINA guidelines) requiring a stable treatment of high doses of ICS and a long acting β2 agonist ± additional asthma controller; 3. Patients who received at least one injection of tezepelumab from February 2024 to March 2025 , according to Italian reimbursement indications; 4. Patients who signed the ICF and privacy form. 5. Patients with continuous enrolment in the data source for at least 12-months before the index date. 6. Patients with at least three months of continuous enrolment in the data source after the index date.
Exclusion criteria
1. Patients with hypersensitivity to the active ingredient or any of the excipients of Tezspire; 2. Patients who received any biologic drug for the treatment of asthma in a clinical trial at any time during the 12-months prior to the index date. 3. Patients who, during the observation period, participated in studies imposing a specific patient's management strategy, which does not correspond to the site's normal clinical practice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demographic and Clinic characterization | Basal | To describe demographic and clinical characteristics of a population of patients with severe asthma who initiated treatment with tezepelumab |
| COMORBIDITIES AND RELEVANT MEDICAL HISTORY | Basal | To describe the respiratory and non-respiratory related conditions in patients with severe asthma who initiated treatment with tezepelumab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exacerbation rate | Basal, 12 months, 24 months | To describe the annualized asthma exacerbation rate in the 12-month period before (baseline period) and up to 12 and 24-months (follow-up period) after initiating treatment with tezepelumab in patients with severe asthma. |
| mOCS (maintenance Oral Corticosteroids) and ICS (Inhaled Corticosteroids) use | Basal, 12 months, 24 months | To describe the mOCS and ICS daily dose in the 12-month period before (baseline period) and up to 12 and 24-months (+/- 2 months, follow-up period) after initiating treatment with tezepelumab in patients with severe asthma |
| ACT (Asthma Control Test) score | Basal, 12 months, 24 months | To describe asthma control (ACT score) from last ACT score recorded before index date (within 12-month baseline period) and up to 12 and 24-months (+/- 2 months, follow-up period) after initiating treatment with tezepelumab in patients with severe asthma. ACT score range 1-25 - 25 means sympthoms under control |
| Asthma Control Questionnaire (ACQ) score | Basal, 12 months, 24 months | To describe ACQ score from last score recorded before index date (within 12-month baseline period) and up to 12 and 24-months (+/- 2 months, follow-up period) after initiating treatment with tezepelumab in patients with severe asthma. ACQ score range 0-6. 6 means severely uncontrolled |
| Lung function FEV1 (L) | Basal, 12 months, 24 months | To describe lung function through FEV1 (Forced Expiratory Volume in 1 Second) from last measurement before index date (within 12-month baseline period) and up to 12 and 24-months (+/- 2 months, follow-up period) after initiating treatment with tezepelumab in patients with severe asthma. |
| Lung function FVC (L) | Basal, 12 months, 24 months | To describe lung function through FVC (Forced vital capacity) from last measurement before index date (within 12-month baseline period) and up to 12 and 24-months (+/- 2 months, follow-up period) after initiating treatment with tezepelumab in patients with severe asthma. |
| Lung function % predicted FVC | Basal, 12 months, 24 months | To describe lung function through % predicted FVC (Forced vital capacity) from last measurement before index date (within 12-month baseline period) and up to 12 and 24-months (+/- 2 months, follow-up period) after initiating treatment with tezepelumab in patients with severe asthma. |
| Lung function % predicted FEV1 | Basal, 12 months, 24 months | To describe lung function through % predicted FEV1 (Forced expiratory volume in 1 second) from last measurement before index date (within 12-month baseline period) and up to 12 and 24-months (+/- 2 months, follow-up period) after initiating treatment with tezepelumab in patients with severe asthma. |
| Biomarkers - BEC (blood eosinophils count) | Basal, 12 months, 24 months | To describe BEC (cells/microL (cells/mm3)) in the 12-month period before (baseline period) and up to 12 and 24-months (+/- 2 months, follow-up period) after initiating treatment with tezepelumab in patients with severe asthma. |
| Biomarkers - FeNO (Fractional exhaled Nitric Oxide) | Basal, 12 months, 24 months | To describe FeNO (ppb) in the 12-month period before (baseline period) and up to 12 and 24-months (+/- 2 months, follow-up period) after initiating treatment with tezepelumab in patients with severe asthma. FeNo range 0-99 |
| Biomarkers - IgE (Immunoglobulin E) | Basal, 12 months, 24 months | To describe blood IgE (IU/mL) in the 12-month period before (baseline period) and up to 12 and 24-months (+/- 2 months, follow-up period) after initiating treatment with tezepelumab in patients with severe asthma. |
| Treatments | Basal, 12 months, 24 months | To describe treatment of asthma in 12-month period before (baseline period) and up to 12 and 24-months (+/- 2 months, follow-up period) after initiating treatment with tezepelumab in patients with severe asthma. |
| Clinical Remission | 12 months, 24 months | To describe frequency and characteristics of patients achieving partial and complete clinical remission after 12 months and 24 months of treatment (+/- 2 months) \[Severe Asthma Network in Italy (SANI) 2023 definition\] \[Canonica G et al, 2023\]. |
Countries
Italy
Outcome results
None listed