Chronic Rhinosinusitis With Nasal Polyposis
Conditions
Keywords
Real World Evidence (RWE), ENT disease, CRSwNP, Nasal Polyp Syndrome, Dupixent, Surgery
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
Interventions
DRUGDupilumab
This study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice.
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of Nasal polyps score (NPS) | From baseline up to 24 months | 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). |
| Change from baseline of Nasal congestion score (NCS) | From baseline up to 24 months | 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. |
| Change from baseline of Smell test scores UPSIT | From baseline up to 24 months | 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. |
| Change from baseline of smell test score Visual Analog Scale (VAS) | From baseline up to 24 months | 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. |
| Change from baseline of Quality of life questionnaire for patients with sino nasal symptoms (SNOT22) | From baseline up to 24 months | SNOT-22 is a patient-reported outcome (PRO) questionnaire. Score ranges from 0 to 110 with higher score indicating greater rhinosinusitis related health burden. |
| Change from baseline of VAS for CRSwNP symptoms | From baseline up to 24 months | 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. |
| Change from baseline of Rhinorrhea score (anterior/posterior) | From baseline up to 24 months | 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. |
| Change from baseline of number of SCS bursts/ surgery for CRSwNP | From baseline up to 24 months | Rescue therapy: The number of SCS bursts/ surgery for CRSwNP will be reported. |
| Health care resource utilization (HCRU) for CRSwNP | From baseline up to 24 months. | Health care resource utilization may include hospitalizations (including length of stay), outpatient visits, emergency room visits, specific transfusion visits. |
| Sense of smell impairment other than related to CRSwNP (Covid19) | From baseline up to 24 months. | Collection of: Sense of smell impairment other than related to CRSwNP (Covid19) will be reported. If present, an Adverse Event (AE) will be recorded. |
| 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 | The number of events and the percentage of patients who had at least one event will be described. |
| Site characteristics | At baseline (Day 1) | Site characteristics (University/general Hospital/private clinic) will be described. |
Countries
France
Contacts
STUDY_DIRECTORClinical Sciences & Operations
Sanofi
Outcome results
None listed