Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Diseases, of Patients With Asthma Treated With Dupilumab (DUPIXENT)

Study Overview
=================
Brief Summary
-----------------
Primary Objective: The primary objective of the study is to characterize patients initiating DUPIXENT for asthma in a real-world setting, with respect to their medical history, including asthma history and asthma treatment history, socio-demographic, biomarkers (including Fractional exhaled nitric oxide [FeNO]), and concomitant treatments for asthma. Secondary Objectives: The secondary objectives of the study are: To characterize real-world use patterns of DUPIXENT for asthma (eg, most commonly used regimens, reason for initiation of new asthma treatments, concomitant therapies, treatment durations, and reasons for discontinuation and/or switching) To assess the effectiveness of DUPIXENT in asthma patients in a real world setting (lung function improvement, exacerbation rate, asthma control) To assess comorbid type 2 conditions (atopic/allergic) and patterns of use and effects of treatment in comorbid conditions in asthma patients treated with Dupixent To collect data on HealthCare Resource Utilization (HCRU) To collect safety data on study participants in the real-world setting.

Detailed Description
-----------------
Each patient will be followed during 36 months.

Official Title
-----------------
PRospEctiVe charactErization of Asthma Patients Treated With DupilumAb in reaL World Setting

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Dupilumab SAR231893


Participation Criteria
=================
Eligibility Criteria
-----------------
- Male or female, 12 years or older Initiating treatment with Dupixent for asthma according to the country-specific prescribing information Willing and able to comply with the required clinic visits, study procedures and assessments. Provided signed informed consent - Most important exclusion criteria for potential participants Patients who have a contraindication to Dupixent according to the country-specific prescribing information Treatment with Dupixent within 6 months before the baseline visit. Note: for patients who have been treated previously with DUPIXENT a washout period of 6 months is required before Visit 1. Any condition that, in the opinion of the Investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from adequately completing the schedule of visits and assessments Patients currently participating in any interventional clinical trial which modifies patient care. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with asthma<br>Eligible participants are initiating treatment with Dupixent for asthma according to the prescribing information in effect in each country | Drug: Dupilumab SAR231893<br>* Pharmaceutical form:solution Route of administration: subcutaneous Dose regimen:<br>* Other names: Dupixent;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Characteristics: Socio-demographics |  | At baseline | 
| Baseline Characteristics: Medical history | Including asthma history and asthma treatment history. | At baseline | 
| Baseline Characteristics: Disease characteristics |  | At baseline | 
| Baseline Characteristics: Concomitant treatments for asthma |  | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dupixent and other asthma treatment use patterns | Including doses and dose frequency, treatment duration, asthma treatment associations (eg, Dupixent monotherapy, Dupixent + inhaled corticosteroids (ICS), Dupixent + ICS + additional controllers, oral corticosteroid (OCS) burst), and reasons for initiation and for discontinuation/switching. | Baseline to Month 54 | 
| Lung function | Pre and post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) over time. | Baseline to Month 54 | 
| Annualized exacerbation rate | An Exacerbation event is defined as a deterioration of asthma requiring: Use of systemic corticosteroids for ≥3 days; or Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. | Baseline to Month 54 | 
| Patient reported outcomes | For asthma and type 2 comorbidities over time. | Baseline to Month 54 | 
| Healthcare Resource Utilization | The Healthcare Resource Utilization (HCRU) is a questionnaire filled out by the participating site at baseline and at clinical visits (scheduled and unscheduled) throughout the study. | Baseline to Month 54 | 
| Number of participants with adverse events (AE) and serious adverse events (SAE) |  | Baseline to Month 54 |