Therapeutic responders of dupilumab for CRSwNP have a different endo- and phenotype substrate of the type-2 inflammation than slow or poor responders as can be assessed by peripheral blood and nasal polyp tissue.
ID
Bron
Verkorte titel
Aandoening
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To identify predicting phenotypical and endotypical biomarkers for the response to dupilumab in adult patients with CRSwNP, by comparing the type 2 inflammation in the peripheral blood and nasal polyp tissue at baseline and after 6 months of treatment with dupilumab between responders and non-responders
Achtergrond van het onderzoek
Observational exploratory study of 91 consecutively included adult patients (≥ 18 years) treated with dupilumab for their CRSwNP as indicated by the ruling guideline EPOS2020. We compare the type-2 inflammation in peripheral blood an nasal polyps at baseline and after 6 months of therapeutic responders with poor responders by histochemical and single cell suspension flow cytometry analysis. The study aims to: 1) identify predicting phenotypical and endotypical biomarkers for the therapeutic response to dupilumab; and 2) define phenotypical differences in the peripheral blood and nasal polyp ILC2s, eosinophils, basophils, and mast cells between responders and poor responders. Therapeutic response is assessed by questionnaires and clinical parameters.
Doel van het onderzoek
Therapeutic responders of dupilumab for CRSwNP have a different endo- and phenotype substrate of the type-2 inflammation than slow or poor responders as can be assessed by peripheral blood and nasal polyp tissue.
Onderzoeksopzet
Materials: baseline, 6 months.
Questionnaires: baseline, 1, 2, 3 and 6 months.
Onderzoeksproduct en/of interventie
No therapeutic interventions. Extra blood withdrawal during standard baseline and 6 months check-up phlebotomy and biopsy of nasal polyp tissue at baseline and 6 months.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
adult patients (≥ 18 years) with CRSwNP with an indication for biological treatment as per the ruling European guideline EPOS2020 who will be treated with dupilumab
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• age ≤ 17 years
• patient is not able to complete the SNOT 22 questionnaire
• strong indication for surgical treatment (e.g.: mucoceles)
• systemic diseases affecting the nose (e.g.: GPA, EGPA, sarcoid, primary ciliary dyskinesia, cystic fibrosis)
• antrochoanal polyps (isolated benign polyps originating from the mucosa of the maxillary sinus with a distinctive small stalk)
• inverted papilloma and malignant polyps
• acute upper or lower respiratory tract infections within 2 weeks before the inclusion visit
• use of systemic corticosteroids within 4 weeks before the inclusion visit
• need for continuous systemic corticosteroid treatment for other disease than CRSwNP
• systemic diseases preventing participation in the study (all comorbidities that have a higher impact on quality of life than CRSwNP and/or making the patient at risk during the study period)
• other systemical medical treatments influencing disease or primary and secondary study outcome measurements such as (non-)selective immunosuppressants (e.g.: azathioprine, methotrexate) and other monoclonal antibodies other than dupilumab (e.g.: adalimumab)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9302 |
| Ander register | METC AMC : METC 2020_254 |