Dupilumab in the treatment of severe uncontrolled chronic rhinosinusitis with nasal polyps ( CRSwNP ): A multicentric observational Phase IV real‐life study ( DUPIREAL )

Chronic rhinosinusitis with nasal polyps (CRSwNP) is associated with significant morbidity and reduced health-related quality of life. Findings from clinical trials have demonstrated the effectiveness of dupilumab in CRSwNP, although real-world evidence is still limited. This Phase IV real-life, obs...

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Bibliographic Details
Published in:Allergy (Copenhagen) Vol. 78; no. 10; pp. 2669 - 2683
Main Authors: De Corso, Eugenio, Pasquini, Ernesto, Trimarchi, Matteo, La Mantia, Ignazio, Pagella, Fabio, Ottaviano, Giancarlo, Garzaro, Massimiliano, Pipolo, Carlotta, Torretta, Sara, Seccia, Veronica, Cantone, Elena, Ciofalo, Andrea, Lucidi, Daniela, Fadda, Gian Luca, Pafundi, Pia Clara, Settimi, Stefano, Montuori, Claudio, Anastasi, Francesca, Pagliuca, Giulio, Ghidini, Angelo, Cavaliere, Carlo, Maffei, Marianna, Bussu, Francesco, Gallo, Stefania, Canevari, Frank Rikki Mauritz, Paludetti, Gaetano, Galli, Jacopo
Format: Journal Article
Language:English
Published: Denmark Blackwell Publishing Ltd 01.10.2023
Subjects:
adrenal cortex hormones
Clinical trials
Comorbidity
Corticosteroids
hypersensitivity
Monoclonal antibodies
Morbidity
nose
Olfaction
Patients
Polyps
Quality of life
Rhinitis
Rhinosinusitis
Sinusitis
smell
Steroid hormones
Surgery
asthma
biologics
smell
chronic rhinosinusitis with nasal polyps
dupilumab
ISSN:0105-4538, 1398-9995, 1398-9995
Online Access:Get full text
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Summary:Chronic rhinosinusitis with nasal polyps (CRSwNP) is associated with significant morbidity and reduced health-related quality of life. Findings from clinical trials have demonstrated the effectiveness of dupilumab in CRSwNP, although real-world evidence is still limited. This Phase IV real-life, observational, multicenter study assessed the effectiveness and safety of dupilumab in patients with severe uncontrolled CRSwNP (n = 648) over the first year of treatment. We collected data at baseline and after 1, 3, 6, 9, and 12 months of follow-up. We focused on nasal polyps score (NPS), symptoms, and olfactory function. We stratified outcomes by comorbidities, previous surgery, and adherence to intranasal corticosteroids, and examined the success rates based on current guidelines, as well as potential predictors of response at each timepoint. We observed a significant decrease in NPS from a median value of 6 (IQR 5-6) at baseline to 1.0 (IQR 0.0-2.0) at 12 months (p < .001), and a significant decrease in Sino-Nasal Outcomes Test-22 (SNOT-22) from a median score of 58 (IQR 49-70) at baseline to 11 (IQR 6-21; p < .001) at 12 months. Sniffin' Sticks scores showed a significant increase over 12 months (p < .001) compared to baseline. The results were unaffected by concomitant diseases, number of previous surgeries, and adherence to topical steroids, except for minor differences in rapidity of action. An excellent-moderate response was observed in 96.9% of patients at 12 months based on EPOS 2020 criteria. Our findings from this large-scale real-life study support the effectiveness of dupilumab as an add-on therapy in patients with severe uncontrolled CRSwNP in reducing polyp size and improving the quality of life, severity of symptoms, nasal congestion, and smell.
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ISSN:0105-4538
1398-9995
1398-9995
DOI:10.1111/all.15772