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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

SEA+NP Patients on FASENRA (benralizumab)

The purpose of this observational study is to describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.

RANS. Study in Patients with Severe Eosinophilic Asthma and Nasal Polyps.

In light of the increasing importance of comorbidities in driving choice for biologics in severe asthma there is a knowledge gap to understand SEA patients with comorbid NP for whom the decision to start biologics was based on the presence of severe, uncontrolled asthma. This retrospective, observational study will describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.

NCT ID

Patient Level Data

Therapeutic Area

This is a retrospective, observational study with secondary data collection
utilizing medical chart review in hospitals or clinical centres that treated SEA + NP patients with benralizumab. Patient data including demographics, clinical characteristics, medication
history, biologic treatment, and NP and asthma clinical outcomes will be abstracted from patient medical charts onto a pre-approved electronic case report form. No personal identifiable data will be collected. Data from all participating centres will be combined into a single anonymised dataset for analysis.

Research Site

Retrospective, Observational Study in Patients with Severe Eosinophilic Asthma and Nasal Polyps treated by FASENRA®

To describe baseline demographics, clinical characteristics, and background treatments, as well as PROs (patient-reported outcomes) for asthma control and HRQoL(health-related quality of life), asthma exacerbation, and healthcare resource utilization.

To describe the distribution (mean, median, range) of NPS (nasal polyp score) before and after initiation of benralizumab among SEA (severe eosinophilic asthma) +NP (nasal polyps) patient. NPS is the sum of the left and the right nostril scores evaluated by nasal endoscopy. Total score ranges from 0 to 8, with higher scores indicate larger-sized polyps.

To describe the distribution (mean, median, range) of NP patient reported HRQoL total score (SNOT-22[Sino-nasal Outcome Test-22]) before and after initiation of benralizumab among EA+NP patients. SNOT-22 measures physical problems, functional limitations, and emotional consequences of sino-nasal conditions. SNOT-22 total score is calculated as the sum of all 22 responses and range from 0 to 110 (higher scores indicate poorer HRQoL).

To describe the use of SCS (systemic corticosteroids) after initiation of benralizumab among SEA + NP patients

To describe asthma exacerbations, PROs, lung function, and benralizumab treatment patterns.

Proportion of patients with different type of surgery and/or procedure

Proportion of patients with repeated or revision surgery

Timing (in days) from first benralizumab dose to NP surgery and/or repeated/revision surgery

Proportion of patients with minor and major surgical complication.

RANS. Study in Patients with Severe Eosinophilic Asthma and Nasal Polyps. - RANS

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