Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis Treated With Dupilumab in France

Condition(s) studied

Investigational drug(s) / intervention(s)

Dupilumab: This study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice.

Study summary

This is a multicentre, non-interventional, single arm study that aims to describe the treatment patterns in France: patients' characteristics, disease characteristics, prior treatments for Severe chronic rhinosinusitis with nasal polyposis and treatment prescription modalities. As well as to assess the clinical outcome after initiation of dupilumab (Dupixent®) and safety of the product during the two years of treatment

Eligibility

Primary outcome measure(s)

• Patient characteristics: Age — At baseline (Day 1)
• Patient characteristics: Sex — At baseline (Day 1)
• Patient characteristics: Weight — At baseline (Day 1)
• Patient characteristics: Height — At baseline (Day 1)
• Patient characteristics: Type 2 comorbidities — At baseline (Day 1)
  The following patient characteristics will be described: Documented comorbidities associated with type 2 inflammation (asthma + severity, atopic dermatitis, Aspirin Exacerbated Disease (AERD), chronic allergic rhinitis)
• Patient characteristics: Medical history — At baseline (Day 1)
  Including CRSwNP history and CRSwNP family history.
• Patient characteristics: Lifestyle habits — At baseline (Day 1)
  Including smoking habits
• Disease characteristics: CRSwNP duration — At baseline (Day 1)
• Disease characteristics: Age at diagnosis of CRSwNP — At baseline (Day 1)
• Disease characteristics: Blood Eosinophils — At baseline (Day 1)
  The results of the last test carried out before Dupixent® initiation will be used as baseline, as per standard of care, if available.
• Disease characteristics: Total serum IgE — At baseline (Day 1)
  The results of the last test carried out before Dupixent® initiation will be used as baseline, as per standard of care, if available.
• Disease characteristics: Anatomopathology — At baseline (Day 1)
  The results of the last exam carried out before Dupixent® initiation will be used as baseline, as per standard of care, if available.
• Disease characteristics: Nasal polyps score (NPS) at baseline — At baseline (Day 1)
  The nasal polyps endoscopic score (NPS) assesses length and distribution of polyps, with a score from 0 to 4 for each nostril, maximum bilateral score of 8 points. Meaning lower (0=no polyp) and higher (4=large polyps).
• Disease characteristics: Nasal congestion score (NCS) at baseline — At baseline (Day 1)
  The Nasal congestion score (NCS) was assessed on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicating more severity.
• Disease characteristics: Rhinorrhea score (anterior/posterior) at baseline — At baseline (Day 1)
  The rhinorrhea scores are scored from 0 ('No symptoms') to 3 ('Severe symptoms'). Where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicating more severity.
• Disease characteristics: VAS for CRSwNP symptoms at baseline — At baseline (Day 1)
  The Visual Analog Scale for CRSwNP assesses symptoms, ranging from 0 to 10: * mild if VAS between 0 and 3 * moderate if VAS between \> 3 and 7 * severe if VAS between \> 7 and 10.
• Disease characteristics: smell test score Visual Analog Scale (VAS) at baseline — At baseline (Day 1)
  Participants value their olfactory function by using the Visual Analogue Scale (VAS), the range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome), where higher score indicated worse thinkable troublesome.
• Concomitant and prior medications for CRSwNP or other disease: Number of patients with at least one prior or concomitant SCS — From baseline up to 24 months.
  Number of patients with at least one prior or concomitant Systemic Corticosteroids (SCS)
• Concomitant and prior medications for CRSwNP or other disease:Type of prior Systemic Corticosteroids (SCS) per patient — From baseline up to 24 months.
  Prior (resp. concomitant) SCS taken (Prednisone/Prednisolone/Betamethasone/Methylprednisolone)
• Concomitant and prior medications for CRSwNP or other disease: Cumulative dose of SCS — From baseline up to 24 months.
  Cumulative dose over the past year
• Concomitant and prior medications for CRSwNP or other disease: Total number of SCS bursts per patient — From baseline up to 24 months.
• Concomitant and prior medications for CRSwNP or other disease: Recovery of sense of smell after SCS — From baseline up to 24 months.
  Recovery of sense of smell after SCS will be described.
• Concomitant and prior medications for CRSwNP or other disease:Time since the most recent SCS burst before initiation of Dupixent® — From baseline up to 24 months.
• Concomitant and prior medications for CRSwNP or other disease: Number of prior or respiratory concomitant biotherapies per patient — From baseline up to 24 months.
  Number of prior, resp. concomitant biotherapies per patient
• Concomitant and prior medications for CRSwNP or other diseases: Indication — From baseline up to 24 months.
  Indication (CRSwNP/Asthma/Atopic dermatitis/Prurigo nodularis/Eosinophilic esophagitis)
• Concomitant and prior medications for CRSwNP or other diseases: Reason for stop — From baseline up to 24 months.
  Reason for stop will be describe.
• Dupilumab (Dupixent®) modalities: Dosage — From baseline up to 24 months.
• Dupilumab (Dupixent®) modalities: Injection modalities — From baseline up to 24 months.
  Injection modalities (Nurse/Caregiver/Self-injection)
• Dupilumab (Dupixent®) modalities: Treatment duration — From baseline up to 24 months.
• Dupilumab (Dupixent®) modalities: Compliance with treatment — From baseline up to 24 months.

Trial sites (1)

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