Observational Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) Treated With Dupilumab in France
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Sanofi
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Patient characteristics: Weight
Study Overview
Brief 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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient aged >= 18 years old at the time of the initiation of the treatment with dupilumab (Dupixent®).
- •Decision to initiate Dupixent® prior to inclusion in the study, initiation of Dupixent® for severe Chronic rhinosinusitis with nasal polyposis (CRSwNP) maximum 3 months before inclusion.
- •Informed consent and willingness to participate.
Exclusion Criteria
- •Conditions or legal situations resulting in impossibility to consent or impacting the interpretation of the results.
- •Patient participating in an interventional clinical trial with experimental product at inclusion.
Arms & Interventions
Dupilumab
The information will be collected during consultation as part of the patient's usual follow-up.
Intervention: Dupilumab (Drug)
Outcomes
Primary Outcomes
Patient characteristics: Weight
Time Frame: At baseline (Day 1)
Patient characteristics: Height
Time Frame: At baseline (Day 1)
Disease characteristics: Nasal polyps score (NPS) at baseline
Time Frame: 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).
Concomitant and prior medications for CRSwNP or other disease:Type of prior Systemic Corticosteroids (SCS) per patient
Time Frame: From baseline up to 24 months.
Prior (resp. concomitant) SCS taken (Prednisone/Prednisolone/Betamethasone/Methylprednisolone)
Disease characteristics: CRSwNP duration
Time Frame: At baseline (Day 1)
Disease characteristics: Rhinorrhea score (anterior/posterior) at baseline
Time Frame: 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: smell test score Visual Analog Scale (VAS) at baseline
Time Frame: 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.
Patient characteristics: Sex
Time Frame: At baseline (Day 1)
Dupilumab (Dupixent®) modalities: Treatment duration
Time Frame: From baseline up to 24 months.
Patient characteristics: Age
Time Frame: At baseline (Day 1)
Patient characteristics: Type 2 comorbidities
Time Frame: 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
Time Frame: At baseline (Day 1)
Including CRSwNP history and CRSwNP family history.
Disease characteristics: Blood Eosinophils
Time Frame: 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: Nasal congestion score (NCS) at baseline
Time Frame: 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: VAS for CRSwNP symptoms at baseline
Time Frame: 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.
Concomitant and prior medications for CRSwNP or other disease: Cumulative dose of SCS
Time Frame: From baseline up to 24 months.
Cumulative dose over the past year
Concomitant and prior medications for CRSwNP or other disease: Recovery of sense of smell after SCS
Time Frame: From baseline up to 24 months.
Recovery of sense of smell after SCS will be described.
Patient characteristics: Lifestyle habits
Time Frame: At baseline (Day 1)
Including smoking habits
Disease characteristics: Age at diagnosis of CRSwNP
Time Frame: At baseline (Day 1)
Dupilumab (Dupixent®) modalities: Dosage
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.
Disease characteristics: Total serum IgE
Time Frame: 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
Time Frame: 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.
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: Number of prior or respiratory concomitant biotherapies per patient
Time Frame: From baseline up to 24 months.
Number of prior, resp. concomitant biotherapies per patient
Concomitant and prior medications for CRSwNP or other diseases: Reason for stop
Time Frame: From baseline up to 24 months.
Reason for stop will be describe.
Concomitant and prior medications for CRSwNP or other disease: Number of patients with at least one prior or concomitant SCS
Time Frame: 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 diseases: Indication
Time Frame: From baseline up to 24 months.
Indication (CRSwNP/Asthma/Atopic dermatitis/Prurigo nodularis/Eosinophilic esophagitis)
Dupilumab (Dupixent®) modalities: Injection modalities
Time Frame: From baseline up to 24 months.
Injection modalities (Nurse/Caregiver/Self-injection)
Dupilumab (Dupixent®) modalities: Compliance with treatment
Time Frame: From baseline up to 24 months.
Secondary Outcomes
- Change from baseline of Nasal polyps score (NPS)(From baseline up to 24 months)
- Change from baseline of number of SCS bursts/ surgery for CRSwNP(From baseline up to 24 months)
- Change from baseline of VAS for CRSwNP symptoms(From baseline up to 24 months)
- Sense of smell impairment other than related to CRSwNP (Covid19)(From baseline up to 24 months.)
- Site characteristics(At baseline (Day 1))
- Change from baseline of Nasal congestion score (NCS)(From baseline up to 24 months)
- Change from baseline of smell test score Visual Analog Scale (VAS)(From baseline up to 24 months)
- Change from baseline of Quality of life questionnaire for patients with sino nasal symptoms (SNOT22)(From baseline up to 24 months)
- Change from baseline of Smell test scores UPSIT(From baseline up to 24 months)
- Health care resource utilization (HCRU) for CRSwNP(From baseline up to 24 months.)
- Change from baseline of Rhinorrhea score (anterior/posterior)(From baseline up to 24 months)
- Number of Adverse Events (AE) / Serious Adverse Events (SAE)(From date of signed ICF or from date of Day 1 whichever comes first, up to 24 months)