Patient Reported Outcomes in Adults With Severe Eosinophilic Asthma on Benralizumab.

The start of an exacerbation is defined as the start-date of systemic corticosteroids or start-date of a temporary increase in a stable oral corticosteroid background dose, or start-date of a hospital admission, whichever occurs earlier.

Data will be presented as an annualized exacerbation rate.

Change in concomitant medications (i.e. oral corticosteroid usage) will be measured.

Assessment of safety and tolerability through measuring the overall change in number of serious adverse events and hospitalizations.

Data will be presented as the proportion of patients experiencing serious adverse events and hospitalizations.

The AQLQ(S)+12 is a questionnaire that measures the health-related quality of life experienced by asthma patients.

The questionnaire comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli).

Patients are asked to recall their experiences during the previous 2 weeks and to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions, and is presented as a score from 1 to 7, with lower overall scores indicating increasing impairement.

The 4 individual domain scores (symptoms, activity limitations, emotional function, and environmental stimuli) are the means of the responses to the questions in each of the domains.

Individual AQLQ(s)+12 Total or domain score changes of ≥0.5 are considered clinically meaningful.

Data will be presented as a mean score and change from baseline with a measure of dispersion.

Health Care Resource Utilization (HCRU) will be measured through the overall change in the number of hospitalization visits, visits to the emergency department, and presenteeism/absenteeism from school/work.

The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

The measurement of the EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, may be converted into a single index value. The index values, presented in country specific value sets, are a major feature of the EQ-5D instrument, facilitating the calculation of quality-adjusted life years (QALYs) that are used to inform economic evaluations of health care interventions.

Index values are presented on a continuum between 0 and 1, with values approaching 1 indicating increasing quality of life (utility).

Data will be presented as mean score as well as a change from baseline score with a measure of dispersion.

The TSQM-9 treatment satisfaction questionnaire is a measure of Effectiveness, Side effects, Convenience, and Global Satisfaction. The scores range from 0 to 100 with higher scores indicating greater satisfaction.

Data will be presented as a mean score with a change from baseline calculation including a measure of dispersion.

The self-reported measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment.

PGIC is a 7 point scale depicting a patient's rating of overall improvement.

Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."

Data will be presented as a mean score with a change from baseline calculation including a measure of dispersion.

PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S item asks the participant to best describe how their asthma symptoms are now ("Check the one number that best describes how your asthma symptoms are now") on a 4-point scale scored as: "normal" (1), "mild" (2), "moderate" (3), or "severe" (4) .

Data will be presented as a mean score with a change from baseline calculation including a measure of dispersion.