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.
Study Type
OBSERVATIONAL
Enrollment
100
Drug prescription according to their marketing approval (subcutaneously, every month or every two weeks)
Hop Claude Huriez Chu Lille
Lille, France
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
Time frame: Day0, Month 6
SNOT 22 (Sinonasal Outcome Test-22) scores
from 0 to 110 , 110 = worst outcome
Time frame: 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
Time frame: 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
Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18
Visual analogical scale (VAS) for rhinorrhea
from 0 to 10, 10 = worst outcome
Time frame: 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
Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18
Number of systemic corticosteroid treatment courses between each visit
number of treatment sequencies
Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18
Delay to first surgical procedure
time between biologic onset and need for surgery
Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18
Blood eosinophil count
number of cells per mm3
Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18
Blood total IgE concentrations
concentration expressed by KUI/L
Time frame: Day 0, Month 3, Month 6, Month 12 and Month 18
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