Use of Dupilumab in Asthma in Real-world Setting (DUPILUMAB)

June 4, 2026 updated by: Hospices Civils de Lyon

Use of Dupilumab in Asthma in Real-world Setting: Analysis of the SNDS Database

The main objective of asthma pharmacological management in adults and teenagers is to maintain long-term control of the disease, including symptom relief, the prevention of exacerbations, the improvement of pulmonary function, the reduction of limitations in daily life and side effects of pharmacological treatments.

Dupilumab is a recombinant human monoclonal antibody that inhibits signalling of both IL-4 and IL-13, two Type 2 cytokines involved in inflammatory pathway. Dupixent obtained a European Marketing Authorization in September 2017 and was reimbursed in France from March 5, 2019 in adults with moderate-to-severe atopic dermatitis. On November 10, 2020, the reimbursement of Dupixent was extended to adults and adolescents aged 12 and over as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils (≥ 0.150 g/L) and/or raised fraction of exhaled nitric oxide (FeNO ≥ 20 ppb), who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Lastly, on July 22, 2021, Dupixent was also reimbursed in patients with severe nasal polyposis.

Primary objective: To describe the characteristics of patients using dupilumab for severe asthma in a real-world setting.

Secondary objectives:

  • To describe the Health Care Resource Use (HCRU) and associated costs of severe asthmatic patients using dupilumab.
  • To describe the use of corticosteroids (oral and inhaled) before and after dupilumab initiation.
  • To study persistence with dupilumab in real-world

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

35000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France
        • Hospices Civils De Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

For this study, we will use the data from the SNDS database. This is the French claims database, which contains all information related to public and private healthcare reimbursements from various regimens in France. It includes all non-hospital reimbursed healthcare expenditures. In 2019, SNIIRAM covered 98.8% of the French population. It also contains demographic characteristics (age, sex, vital status), information on healthcare professionals, presence of chronic condition with ICD-10 codes, as well as information on date and nature of medical and paramedical interventions, laboratory tests, medical transportations, and number of days of paid sick leaves. These data are linked to the hospital discharge ICD-10 diagnoses codes for all medical, obstetric, and surgery hospitalizations, medical procedures, hospitalization department, and cost coding system. Data are also linked to the national deaths database for medical causes of death.

Description

Inclusion Criteria:

  • At least one reimbursement of dupilumab during the inclusion period from November 10, 2020 to December 31, 2023

  • At least one of the following asthma markers:

    • at least one reimbursement of inhaled corticosteroids (ICS and fixed-dose combination ICS/LABA inhalers) in a 3-month time-window before and after one of the reimbursement of dupilumab
    • A Long-Term Disease (LTD) for asthma in the 12 months before dupilumab initiation or over follow-up.
    • An hospital admission for asthma in the 12 months before dupilumab initiation or over follow-up.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study cohort

* Patients will be included in the study if they meet the following inclusion criteria:

  • At least one reimbursement of dupilumab during the inclusion period from November 10, 2020 to December 31, 2023 AND
  • Be 12 years or older at dupilumab initiation. AND

  • At least one of the following asthma markers:

    • At least one reimbursement of inhaled corticosteroids (ICS and fixed-dose combination ICS/LABA inhalers) in a 3-month time-window before and after one of the reimbursement of dupilumab
    • A Long-Term Disease (LTD) for asthma in the 12 months before dupilumab initiation or over follow-up.
    • An hospital admission for asthma in the 12 months before dupilumab initiation or over follow-up.

Two subgroups: 12 to 18 y.o. subgroup vs. 18 and+ y.o. subgroup

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's characteristics
Time Frame: At index date, i.e. at the date of the 1st reimbursement of Dupilumab over the inclusion period (betw Nov 10, 2020 and Dec 31, 2023)

Age at index date

  • Sex
  • Affiliation of Complementary universal healthcare coverage (CMU-C)

  • Comorbidities in the 12 months before dupilumab initiation, from diagnoses recorded during hospitalization or LTD status and medications :

    • Diabetes

    • Cardiovascular diseases

      • disabling stroke,
      • chronic arterial diseases,
      • heart failure, arrhythmias, valvular and severe congenital heart disease,
      • severe hypertension,
      • coronary heart disease,
    • Mental illness, including depression/anxiety
    • Eosinophilic Esophagitis
    • Nodular prurigo
    • Atopic dermatitis
    • Osteoporosis

The characteristics of patients will be described in the overall cohort and in age subgroups ([12-18[ and ≥ 18 years old).
At index date, i.e. at the date of the 1st reimbursement of Dupilumab over the inclusion period (betw Nov 10, 2020 and Dec 31, 2023)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL24_0491
  • 26-5238 (Other Identifier: Hospices Civils de Lyon (AGORA))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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