BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry (BIOPOSE2)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Nasal Polyps; Rhinosinusitis Chronic
• Intervention / Treatment: Drug: Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval).

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geoffrey Mortuaire, MD, pHD; Phone Number: 0320445675; Email: geoffrey.mortuaire@chru-lille.fr
• Study Contact Backup: Name: Geoffrey Mortuaire; Phone Number: 0320445675; Email: geoffrey.mortuaire@chru-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • CHU de Lille
    • Contact: Geoffrey MORTUAIRE, Pr; Phone Number: 03 20 44 59 62; Email: geoffrey.mortuaire@chu-lille.fr
  • Lille, France
    • Active, not recruiting
    • CHU de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Biologic treatments available; Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval).	Drug: Biologic 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of quality of life over 5 years according to the asthmatic status of the patients	Assessment of disease control with the Sino-nasal outcome test-22. from 0 to 110, 110=worst outcome	5-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life progression in patients with Chronic Rhinosinusitis with Nasal Polyps	Assessment of disease control with the Sino-nasal outcome test-22. from 0 to 110, 110=worst outcome	Evaluation after 6 months of treatment with biologics
Patient reported symptoms measurement	Number of oral corticosteroid treatment courses between each visit (in grammes)	Month 0, Month 3, Month 6, and every 6 months until 5 years
Time to first surgical procedure since the beginning of biologic treatment	Date and type of sinus surgery between each visit	MMonth 0, Month 3, Month 6, and every 6 months until 5 years
Blood eosinophil count and total IgE blood concentrations evolution during the course of the 5-year follow-up	Number off cells per mm3	Month 0, Month 3, Month 6, and every 6 months until 5 years

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2024
• Primary Completion (Estimated): September 2, 2034
• Study Completion (Estimated): January 2, 2035

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: chronic rhinosinusitis; eosinophil; nasal polyp; endotype
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Signs and Symptoms; Nasal Polyps; Anti-Asthmatic Agents; Respiratory System Agents; dupilumab; mepolizumab
• Other Study ID Numbers: 2023_0682

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No