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
Study Type
OBSERVATIONAL
Enrollment
150
This study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice.
Investigational Site Number: 250.0001
Nantes, France
Patient characteristics: Age
Time frame: At baseline (Day 1)
Patient characteristics: Sex
Time frame: At baseline (Day 1)
Patient characteristics: Weight
Time frame: At baseline (Day 1)
Patient characteristics: Height
Time frame: At baseline (Day 1)
Patient characteristics: Type 2 comorbidities
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)
Time frame: At baseline (Day 1)
Patient characteristics: Medical history
Including CRSwNP history and CRSwNP family history.
Time frame: At baseline (Day 1)
Patient characteristics: Lifestyle habits
Including smoking habits
Time frame: At baseline (Day 1)
Disease characteristics: CRSwNP duration
Time frame: At baseline (Day 1)
Disease characteristics: Age at diagnosis of CRSwNP
Time frame: At baseline (Day 1)
Disease characteristics: Blood Eosinophils
The results of the last test carried out before Dupixent® initiation will be used as baseline, as per standard of care, if available.
Time frame: At baseline (Day 1)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Disease characteristics: Total serum IgE
The results of the last test carried out before Dupixent® initiation will be used as baseline, as per standard of care, if available.
Time frame: At baseline (Day 1)
Disease characteristics: Anatomopathology
The results of the last exam carried out before Dupixent® initiation will be used as baseline, as per standard of care, if available.
Time frame: At baseline (Day 1)
Disease characteristics: Nasal polyps score (NPS) at baseline
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).
Time frame: At baseline (Day 1)
Disease characteristics: Nasal congestion score (NCS) at baseline
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.
Time frame: At baseline (Day 1)
Disease characteristics: Rhinorrhea score (anterior/posterior) at baseline
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.
Time frame: At baseline (Day 1)
Disease characteristics: VAS for CRSwNP symptoms at baseline
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.
Time frame: At baseline (Day 1)
Disease characteristics: smell test score Visual Analog Scale (VAS) at baseline
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.
Time frame: At baseline (Day 1)
Concomitant and prior medications for CRSwNP or other disease: Number of patients with at least one prior or concomitant SCS
Number of patients with at least one prior or concomitant Systemic Corticosteroids (SCS)
Time frame: From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other disease:Type of prior Systemic Corticosteroids (SCS) per patient
Prior (resp. concomitant) SCS taken (Prednisone/Prednisolone/Betamethasone/Methylprednisolone)
Time frame: From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other disease: Cumulative dose of SCS
Cumulative dose over the past year
Time frame: From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other disease: Total number of SCS bursts per patient
Time frame: From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other disease: Recovery of sense of smell after SCS
Recovery of sense of smell after SCS will be described.
Time frame: From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other disease:Time since the most recent SCS burst before initiation of Dupixent®
Time frame: From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other disease: Number of prior or respiratory concomitant biotherapies per patient
Number of prior, resp. concomitant biotherapies per patient
Time frame: From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other diseases: Indication
Indication (CRSwNP/Asthma/Atopic dermatitis/Prurigo nodularis/Eosinophilic esophagitis)
Time frame: From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other diseases: Reason for stop
Reason for stop will be describe.
Time frame: From baseline up to 24 months.
Dupilumab (Dupixent®) modalities: Dosage
Time frame: From baseline up to 24 months.
Dupilumab (Dupixent®) modalities: Injection modalities
Injection modalities (Nurse/Caregiver/Self-injection)
Time frame: From baseline up to 24 months.
Dupilumab (Dupixent®) modalities: Treatment duration
Time frame: From baseline up to 24 months.
Dupilumab (Dupixent®) modalities: Compliance with treatment
Time frame: From baseline up to 24 months.
Change from baseline of Nasal polyps score (NPS)
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).
Time frame: From baseline up to 24 months
Change from baseline of Nasal congestion score (NCS)
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.
Time frame: From baseline up to 24 months
Change from baseline of Smell test scores UPSIT
The UPSIT (UPSIT 40-odorant test) quantifies human olfactory function. Being the scores: ≤ 18 (anosmia) / \[19-25\] (severe hyposmia) / \[26-30\] (moderate hyposmia) / \[31-34\] (mild hyposmia) / \[35-40\] (normosmia)). A higher score indicating a better function.
Time frame: From baseline up to 24 months
Change from baseline of smell test score Visual Analog Scale (VAS)
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.
Time frame: From baseline up to 24 months
Change from baseline of Quality of life questionnaire for patients with sino nasal symptoms (SNOT22)
SNOT-22 is a patient-reported outcome (PRO) questionnaire. Score ranges from 0 to 110 with higher score indicating greater rhinosinusitis related health burden.
Time frame: From baseline up to 24 months
Change from baseline of VAS for CRSwNP symptoms
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.
Time frame: From baseline up to 24 months
Change from baseline of Rhinorrhea score (anterior/posterior)
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.
Time frame: From baseline up to 24 months
Change from baseline of number of SCS bursts/ surgery for CRSwNP
Rescue therapy: The number of SCS bursts/ surgery for CRSwNP will be reported.
Time frame: From baseline up to 24 months
Health care resource utilization (HCRU) for CRSwNP
Health care resource utilization may include hospitalizations (including length of stay), outpatient visits, emergency room visits, specific transfusion visits.
Time frame: From baseline up to 24 months.
Sense of smell impairment other than related to CRSwNP (Covid19)
Collection of: Sense of smell impairment other than related to CRSwNP (Covid19) will be reported. If present, an Adverse Event (AE) will be recorded.
Time frame: From baseline up to 24 months.
Number of Adverse Events (AE) / Serious Adverse Events (SAE)
The number of events and the percentage of patients who had at least one event will be described.
Time frame: From date of signed ICF or from date of Day 1 whichever comes first, up to 24 months
Site characteristics
Site characteristics (University/general Hospital/private clinic) will be described.
Time frame: At baseline (Day 1)