Nasal Polyps, Rhinosinusitis Chronic
Conditions
Keywords
nasal polyp, chronic rhinosinusitis, eosinophil, endotype
Brief summary
With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed. During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production. New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies. Herein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.Patient-reported outcomes will be addressed according to their initial clinical profile (allergy, asthma, NSAID, gastroesophageal reflux disease, obstructive apnea, otologic disorder, smoke habit).
Interventions
DRUGBiologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval).
Drug prescription according to their marketing approval (subcutaneously, every month or every two weeks).
Sponsors
University Hospital, Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval. * The patients already treated according to this criteria since August 2021 will be followed and their previous clinical and biological data retrospectively collected
Exclusion criteria
* Oral corticotherapy in the previous month; * Biologic treatment with anti-IgE (omalizumab), anti-IL-5/IL-5R (mepolizumab, benralizumab) or anti-IL-4/IL-13R (dupilumab) or any other biotherapy for inflammatory diseases in the previous 6 months of initiation of treatment apart from ongoing biotherapies for severe asthma or CRSwNP; * Hypersensitivity to humanized antibodies ; * Documented SARS-Cov2 infection in the last 3 months with persistent olfactory disorders related to COVID; * Pregnant or breast-feeding women; * Patient without social coverage.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of quality of life over 5 years according to the asthmatic status of the patients | 5-year follow-up | Assessment of disease control with the Sino-nasal outcome test-22. from 0 to 110, 110=worst outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life progression in patients with Chronic Rhinosinusitis with Nasal Polyps | Evaluation after 6 months of treatment with biologics | Assessment of disease control with the Sino-nasal outcome test-22. from 0 to 110, 110=worst outcome |
| Patient reported symptoms measurement | Month 0, Month 3, Month 6, and every 6 months until 5 years | Number of oral corticosteroid treatment courses between each visit (in grammes) |
| Time to first surgical procedure since the beginning of biologic treatment | MMonth 0, Month 3, Month 6, and every 6 months until 5 years | Date and type of sinus surgery between each visit |
| Blood eosinophil count and total IgE blood concentrations evolution during the course of the 5-year follow-up | Month 0, Month 3, Month 6, and every 6 months until 5 years | Number off cells per mm3 |
Countries
France
Contacts
CONTACTGeoffrey Mortuaire, MD, pHD
CONTACTGeoffrey Mortuaire
Outcome results
None listed