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.
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.
Study Type
OBSERVATIONAL
Enrollment
273
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.
Baseline demographics, clinical characteristics, and background treatments, as well as PROs for asthma control and HRQoL, asthma exacerbation, and healthcare resource utilization.
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.
Time frame: At or up to 12 months prior to first benralizumab dose.
Total NPS
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.
Time frame: Up to 12 months prior to and up to 12 months from first benralizumab dose.
SNOT-22 total score
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).
Time frame: Up to 12 months prior to and up to 12 months from first benralizumab dose.
Overall SCS use. SCS use for asthma only. SCS use for NP only
To describe the use of SCS (systemic corticosteroids) after initiation of benralizumab among SEA + NP patients
Time frame: Up to 12 months from first benralizumab dose.
Asthma Clinical outcomes.
To describe asthma exacerbations, PROs, lung function, and benralizumab treatment patterns.
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Research Site
Centennial, Colorado, United States
Research Site
Denver, Colorado, United States
Research Site
Glendale, New York, United States
Research Site
New York, New York, United States
Research Site
Rochester, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Norfolk, Virginia, United States
Research Site
Lyon, France
Research Site
Marseille, France
...and 35 more locations
Time frame: Up to 12 months from first benralizumab dose.
NP surgery type and/or procedure
Proportion of patients with different type of surgery and/or procedure
Time frame: Up to 12 months from first benralizumab dose.
Repeated or revision surgery for NP
Proportion of patients with repeated or revision surgery
Time frame: Up to 12 months from first benralizumab dose.
Time to NP surgery
Timing (in days) from first benralizumab dose to NP surgery and/or repeated/revision surgery
Time frame: Up to 12 months from first benralizumab dose.
NP surgery complications
Proportion of patients with minor and major surgical complication.
Time frame: Up to 12 months from first benralizumab dose.