BIOlogics in Severe Nasal POlyposis SurvEy

Study Overview
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Brief Summary
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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.

Official Title
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Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps

Conditions
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Chronic Rhinosinusitis With Nasal Polyps

Intervention / Treatment
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* Drug: Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval)|Drug prescription according to their marketing approval (subcutaneously, every month or every two weeks)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month rate of patients with a SNOT-22 (Sinonasal Outcome test -22) score change over the minimal clinically important difference of 8.9 by comparison of SNOT-22 scores measured at Month 0 and Month 6 | from 0 to 110 , 110 = worst outcome | Day0, Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNOT 22 (Sinonasal Outcome Test-22) scores | from 0 to 110 , 110 = worst outcome | Day 0, Month 3, Month 6, Month 12 and Month 18 | 
| Visual analogical scale (VAS) for nasal obstruction | from 0 to 10, 10 = worst outcome | Day 0, Month 3, Month 6, Month 12 and Month 18 | 
| Visual analogical scale (VAS) for smell lost | from 0 to 10, 10 = worst outcome | Day 0, Month 3, Month 6, Month 12 and Month 18 | 
| Visual analogical scale (VAS) for rhinorrhea | from 0 to 10, 10 = worst outcome | Day 0, Month 3, Month 6, Month 12 and Month 18 | 
| Visual analogical scale (VAS) for craniofacial pain | from 0 to 10, 10 = worst outcome | Day 0, Month 3, Month 6, Month 12 and Month 18 | 
| Number of systemic corticosteroid treatment courses between each visit |  | Day 0, Month 3, Month 6, Month 12 and Month 18 | 
| Delay to first surgical procedure |  | Day 0, Month 3, Month 6, Month 12 and Month 18 | 
| Blood eosinophil count | number of cells per mm3 | Day 0, Month 3, Month 6, Month 12 and Month 18 | 
| Blood total IgE concentrations | concentration expressed by KUI/L | Day 0, Month 3, Month 6, Month 12 and Month 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biologic, nasal polyp, chronic rhinosinusitis, eosinophil, endotype