Use of Dupilumab in Asthma in Real-world Setting

NCT07637292 | Active Not Recruiting

• 2 other identifiers: 69HCL24_049126-5238
• Study Type: observational
• Target: 35,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma Acute

Keywords

Recombinant human monoclonal antibody; SNDS database; Real-life setting

Outcome Measures

Primary Outcomes (1)

• Patient's characteristics

  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)

Study Arms (1)

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

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Lyon, France

Location

Related Publications (3)

• Tuppin P, Rudant J, Constantinou P, Gastaldi-Menager C, Rachas A, de Roquefeuil L, Maura G, Caillol H, Tajahmady A, Coste J, Gissot C, Weill A, Fagot-Campagna A. Value of a national administrative database to guide public decisions: From the systeme national d'information interregimes de l'Assurance Maladie (SNIIRAM) to the systeme national des donnees de sante (SNDS) in France. Rev Epidemiol Sante Publique. 2017 Oct;65 Suppl 4:S149-S167. doi: 10.1016/j.respe.2017.05.004. Epub 2017 Jul 27.

  PMID: 28756037 BACKGROUND

• Rabe KF, Nair P, Brusselle G, Maspero JF, Castro M, Sher L, Zhu H, Hamilton JD, Swanson BN, Khan A, Chao J, Staudinger H, Pirozzi G, Antoni C, Amin N, Ruddy M, Akinlade B, Graham NMH, Stahl N, Yancopoulos GD, Teper A. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. N Engl J Med. 2018 Jun 28;378(26):2475-2485. doi: 10.1056/NEJMoa1804093. Epub 2018 May 21.

  PMID: 29782224 BACKGROUND

• Busse WW, Maspero JF, Rabe KF, Papi A, Wenzel SE, Ford LB, Pavord ID, Zhang B, Staudinger H, Pirozzi G, Amin N, Akinlade B, Eckert L, Chao J, Graham NMH, Teper A. Liberty Asthma QUEST: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Dupilumab Efficacy/Safety in Patients with Uncontrolled, Moderate-to-Severe Asthma. Adv Ther. 2018 May;35(5):737-748. doi: 10.1007/s12325-018-0702-4. Epub 2018 May 3.

  PMID: 29725983 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start: January 2, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

FR (1)