Real-World Evidence and Phase IV studies in CRSwNP
Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) generally have a high symptom burden and poor health-related quality of life (QoL), often requiring recurring systemic corticosteroid use and repeated sinus surgery.
Dupilumab is approved as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.1 Dupilumab has demonstrated its efficacy in pivotal clinical trials to rapidly reduce nasal polyp size, alleviate nasal congestion, restore olfactory function, improve QoL, lower systemic corticosteroid use, and improve comorbidities for patients with severe uncontrolled CRSwNP.2,3
Real-world evidence (RWE) complements clinical trial data by demonstrating how treatments perform in unselected patient populations under routine clinical practice conditions. Additional evidence can also be collected from phase IV studies. For CRSwNP, this evidence is particularly valuable given the complex and heterogeneous nature of the disease.
Clinical practice insights: RWE and phase IV studies
EVEREST study highlights
First ever direct Head-to-Head Comparison of Dupilumab vs Omalizumab in Patients with Severe CRSwNP and Coexisting Asthma.
DUPIREAL: Two-Year Turning Point with Dupilumab in CRSwNP
DUPIREAL is the largest long-term real-world study (n=926) evaluating the effectiveness of dupilumab, including treatment response, disease control and remission, in severe uncontrolled CRSwNP over 2 years.
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DUPIXENT Summary of Product Characteristics, 2025.
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Bachert C, et al. Efficacy and safety of dupilumab in severe CRSwNP: LIBERTY NP SINUS-24 and SINUS-52 trials. Lancet. 2019;394(10209):1638–1650.
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Desrosiers M, et al. Dupilumab reduces systemic corticosteroid use and surgery rate in CRSwNP. Rhinology. 2021;59(3):301–311.
Relaterade Artiklar
DUPIREAL: Two-Year Turning Point with Dupilumab in CRSwNP
The results from the DUPIREAL real-world study reinforce the efficacy of dupilumab demonstrated in the SINUS-24 and SINUS-52 randomized clinical trials and are consistent with the approved SmPC.1,2,3,4 DUPIREAL is the largest long-term real-world study (n=926) evaluating the effectiveness of dupilumab, including treatment response, disease control and remission, in severe uncontrolled CRSwNP over 2 years.2,3
EVEREST study: First ever direct Head-to-Head Comparison of Dupilumab vs Omalizumab in Patients with Severe CRSwNP and Coexisting Asthma
First ever direct Head-to-Head Comparison of Dupilumab vs Omalizumab in Patients with Severe CRSwNP and Coexisting Asthma.
Uncovering the Hidden Burden: Understanding Loss of Smell in CRSwNP
Navigating the Complexities of Smell Loss in Patients with CRSwNP.
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