Biologic treatment of rhinosinusitis with nasal polyposis in real-world Danish patients - a direct comparison of dupilumab and mepolizumab

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 220

Inclusion Criteria

Chronic Rhinosinusitis with bilateral nasal polyposis, Age above 18 years, Able to read and/or speak Danish, Evidence of type 2 inflammation as measured by either eosinophilia in blood or tissue (in accordance with EPOS2020), or late-onset eosinophilic asthma, At least one endoscopic sinus surgery within the previous seven years (or not being fit to undergo sinus surgery), Adherence to nasal steroid spray and nasal douches twice a day for a period of at least three months until start of treatment, Additionally: at least three of the following five: 1) need for systemic corticosteroids (OCS), at least two/year or one long term treatment lasting more than three months, or having contraindications to OCSs, 2) Sino-nasal outcome test 22 (SNOT-22) score of at least 50, 3) Reduced sense of smell (Defined as Sniffin Sticks-Evaluation Identification Test 16 (UPSIT-16) score 0-8, 4) Nasal polyp score (NPS) of minimum 2 on both sides, and a minimum score of 5 in total, 5) Asthma requiring inhaled corticosteroids

Exclusion Criteria

Systemic corticosteroid treatment within the last three months, Pregnant or breastfeeding patients., Endoscopic sinus surgery (ESS) within the last six months, Non-adherent to medicine regimens, Hypersensitivity to the active substance or any of the excipients in the two IMPs, Not able to understand spoken and/or written Danish, Prior treatment with any biologic drug aimed at type II disease within the previous six months, Prior treatment failure with one of the two IMPs for any indication, Eosinophilic blood cell count of =1.5x109cells/L (at baseline, i.e. before first injection), Pronounced fear of needles

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of mepolizumab versus dupilumab on objective and subjective symptoms of CRSwNP and related comorbidities in an attempt to determine non-inferiority between the two, or possibly; superiority of dupilumab over mepolizumab.;Secondary Objective: The secondary objective is to explore any other relevant differences between mepolizumab and dupilumab in terms of frequency of AEs, need for rescue treatments, diversity in outcome based on endotype or comorbidity or other factors, that can lead to a patient-centreed approach, when choosing treatment for CRSwNP;Primary end point(s): Co-primary endpoint 1: Change in nasal polyp score (NPS) at 24 weeks, Co-primary endpoint 2: Change in SNOT-22 score at 24 weeks

Secondary Outcome Measures