Assessing Long-Term Outcomes of DUPIXENT® Treatment in Patients with Chronic Rhinosinusitis with Nasal Polyposis (AROMA)

Study type

• Study topic:
  Herbal medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

  Evaluation of patient-reported outcomes

  Other

  Safety study (incl. comparative)
• If ‘other’, further details on the scope of the study:
  Characterization of population receiving therapy

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational prospective product registry

Study drug and medical condition

• Medicinal product name:
  DUPIXENT
• Study drug International non-proprietary name (INN) or common name:
  DUPILUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (D11AH05) dupilumab

  dupilumab
• Medical condition to be studied:
  Chronic rhinosinusitis with nasal polyps

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  709

Study design details

• Main study objective:
  • To longitudinally characterize the long-term effectiveness of DUPIXENT® through assessment of patient-reported symptoms, HRQoL related to CRSwNP and other type 2 comorbidities and their change over-time. ; • To characterize patients who receive DUPIXENT® for CRSwNP in a real-world setting with respect to their medical history, demographic and disease characteristics, and type 2 comorbidities
• Outcomes:
  • Baseline Patient Characteristics ; • Baseline Disease Characteristics, ; • Descriptive summaries of DUPIXENT and other CRSwNP treatments used during the study as defined in the protocol ; • Reasons for initiation of new CRSwNP treatments, concomitant therapies, treatment durations, and reasons for discontinuation and/or switching ; • Global assessment of disease severity and treatment satisfaction ; • Descriptive summary of adverse events See add'l info NCT04959448
• Data analysis plan:
  Data collected in this registry will be analyzed descriptively.