A Study in Male and Female Adolescent Participants With Severe Uncontrolled Asthma Starting Treatment With Dupilumab Injection (Dupixent®)

Relevant medical history other than asthma according to the investigator (including documented comorbidities associated with type 2 inflammation). Asthma history includes patient age at the time of diagnosis and family history.

Background asthma treatments (doses and international nonproprietary name (INN) of inhaled corticosteroids (ICS), long-acting beta-2 agonist (LABA) and oral corticosteroids (OCS), etc) including cumulative yearly dose of OCS. Use of oral corticosteroids due to exacerbation of asthma (dose, INN). Use of emergency treatments (short-acting beta-2 agonist (SABA)) (number of times per week).

Age and gender.

Disease characteristics at the inclusion including severity (Global Initiative for Asthma (GINA) step), number of severe exacerbations during the past year, number of days in intensive care unit (ICU) for severe exacerbation since the diagnosis, forced expiratory volume per second (FEV1), Asthma Control Test (ACT) score.

Relevant concomitant medication other than medication for asthma according to the investigator.

ACT score range: 5-25; higher score indicates better asthma control.

An exacerbation is defined as deterioration of asthma requiring use of systemic corticosteroids for ≥3 days; or increase in oral corticosteroids (OCS) dose at ≥2 times the current dose for ≥3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.

Questionnaire including 23 questions in 3 domains (symptoms, activity limitation, emotional function) and a 7-point scale (7 = not bothered at all; 1 = extremely bothered).

Change in corticosteroid dose.

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Following food allergic reactions will be recorded: allergic symptoms and anaphylaxis in real life or during an oral food challenge.

VAS score range: 0 ('no symptoms') to 100 ('severe symptoms').

SCORAD is a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis as objectively as possible with scores ranging from 0-100. The higher the score indicates more severe atopic dermatitis.

Following sinonasal symptoms will be recorded: nasal congestion, loss in smell, posterior nasal discharge, anterior nasal discharge.

A participant is defined as responder if he/she has a change from baseline of 3 points or more at week 52 on the ACT score. ACT score range: 5-25; higher score indicates better asthma control.

A participant is defined as responder if he/she has a change from baseline of 0.5 points or more at week 52 on the PAQLQ score. The PAQLQ(S) overall score is calculated by adding points of individual responses to all questions, with the higher scores indicating less impairment that is, a better quality of life. Questionnaire including 23 questions in 3 domains (symptoms, activity limitation, emotional function) and a 7-point scale (7 = not bothered at all; 1 = extremely bothered).

All reasons for treatment discontinuation.

Number of adverse events.

Number of serious adverse events.