BIOlogics in Severe Nasal POlyposis SurvEy (BIOPOSE)

University Hospital, Lille

Status: Enrolling

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Treatments: Drug: Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval)

Study type: Observational

Funder types: Other

Identifiers

NCT05228041

DRI_2021/0030

Details and patient eligibility

About

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 we 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval

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 apart from ongoing biotherapies for severe asthma;
• 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