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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 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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval) | Drug | Drug prescription according to their marketing approval (subcutaneously, every month or every two weeks) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey Mortuaire, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hop Claude Huriez Chu Lille | Lille | 59037 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38749694 | Result | Favier V, Daveau C, Carsuzaa F, Fieux M, Vandersteen C, Castillo L, Papon JF, de Gabory L, Saroul N, Verillaud B, Rumeau C, Jankowski R, Michel J, de Bonnecaze G, Lecanu JB, Coste A, Bequignon E, Malard O, Mortuaire G. Study protocol: the biologics in severe chronic rhinosinusitis with nasal polyps survey. BMJ Open. 2024 May 15;14(5):e083112. doi: 10.1136/bmjopen-2023-083112. |
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| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
| C434107 | mepolizumab |
| D000069444 | Omalizumab |
| C000622721 | tezepelumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| 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 | number of treatment sequencies | Day 0, Month 3, Month 6, Month 12 and Month 18 |
| Delay to first surgical procedure | time between biologic onset and need for surgery | 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 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |