A Real World Study to Capture Clinical and Patient Centered Outcomes in Adults With Severe Eosinophilic Asthma Treated With Benralizumab.

A Real World Multicenter 48 Week Prospective Cohort Study to Capture Clinical and Patient Centered Outcomes in Adults With Severe Eosinophilic Asthma Treated With Benralizumab in Routine Care Settings in Greece

Severe eosinophilic asthma (SEA) is associated with poor disease control and compromised health-related quality of life (HRQoL), leading to a substantial psychosocial and economic disease burden. Benralizumab (Fasenra®), an interleukin (IL)-5-alpha receptor monoclonal antibody, is approved as an add-on maintenance treatment for SEA.

This study aims at collecting real-world data that extend beyond the clinical effectiveness of benralizumab to the participant-reported impact of treatment on their HRQoL, sleep quality, depression, anxiety, work productivity and activity impairment, but also on treatment effectiveness. Recent technological advances in portable spirometers and wearable activity trackers (WAT) to increase physical activity for participants with asthma, even for older participants, allow this study to collect data on lung function parameters and physical activity from such devices for the first time at a country level in Greece. Using a multi-aspect approach, this study will generate real-world evidence on a broad range of both well-established clinical and novel patient-centered outcomes which are critical to the assessment of the therapeutic benefit both from the physician's and the participant's perspective. All main study outcomes will be examined at various timepoints throughout the course of the 48-week observation period, starting as early as 4 weeks after treatment initiation, thus enabling the identification of 'early' treatment responders with a closer focus on patients' physical and psychological well-being and HRQoL in addition to asthma control and lung function metrics

Inclusion Criteria:

• Male or female outpatients aged 18 to 75 years (inclusive) at the time of benralizumab prescription
• Patients with physician-diagnosed Severe Eosinophilic Asthma SEA inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus long-acting β-agonists (LABA)
• Patients who have been prescribed but not yet initiated treatment with benralizumab according to the Summary of Product Characteristics (SmPC), prior to signed Informed Consent, and for whom the decision to prescribe this therapy is clearly separated from the physician's decision to include the patient in the current study
• For patients that are not Oral Corticosteroid (OCS)-dependent: Blood eosinophil count (BEC) ≥150 cells/μL in the 2 weeks before benralizumab initiation and a historical value of ≥300 cells/μL during the previous year
• For OCS-dependent patients: BEC ≥150 cells/μL in the 2 weeks before benralizumab initiation or a historical value of ≥300 cells/μL during the previous year
• History of ≥1 documented Clinically Significant Exacerbations (CSE) in the 48 weeks prior to benralizumab initiation, and of ≥2 CSEs in the previous 24 months
• Patients must be willing and able to read and complete the study specific questionnaires
• Patients must be willing and able to use the study-specific wearable/handheld devices.

Note: This requirement applies only at the time of benralizumab (Fasenra®) prescription. If a patient stops using any or both of the aforementioned devices for any reason during his/her participation in the study, (s)he may continue participating in the study and this will not be considered as a reason for withdrawal.

-Patients must provide a written Informed Consent prior to inclusion to the study

Exclusion Criteria:

• Patients that meet any of the contraindications to the administration of the benralizumab outlined in the SmPC
• Concomitant treatment with any other biologic agent for any indication
• Previous exposure to anti-IL5/ILR5 treatment
• Exposure to omalizumab in the past 6 months prior to benralizumab initiation
• Clinically important pulmonary disease other than asthma or ever been diagnosed with any disease, other than asthma, that is associated with elevated BEC
• Acute upper or lower respiratory infections within 8 weeks prior to the date of informed consent
• Heavy smokers with a >20 pack-year smoking history
• Currently pregnant (or intention to become pregnant within the study period), breastfeeding or lactating women
• Known evidence of lack of adherence to asthma controller medications
• Use of immunosuppressive medication (including but not limited to: OCS [for reasons other than asthma], methotrexate, troleandomycin, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroids [for reasons other than asthma] or any experimental anti-inflammatory therapy) within 3 months prior to the date of informed consent
• Patients who currently receive treatment with any investigational drug/device/intervention or who have received any investigational product within 30 days or 5 half-lives of the investigational agent (whichever is longer) before benralizumab initiation