Background 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. Methods 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. Results 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. Conclusions 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.

Dupilumab in the treatment of severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP): A multicentric observational Phase IV real-life study (DUPIREAL) / 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; Spanu, Camilla; Porru Davide, Paolo; Lo Verde, Simone; Corbò, Marco; Cantiani, Alessandro; Furno, Daniela; D’Agostino, Giuseppe; D’Auria Leandro, Maria; De Maio, Gabriele; Di Bella Giuseppe, Alberto; Penazzi, Daniele; Mele Dario, Antonio; Di Cesare, Tiziana; Andrea, Rampi; Umberto, Tanzini; Saccardo, Tommaso; Roccuzzo, Giuseppe; Cipolla, Federica; Ragusa, Martina; Grigaliute, Egle; Alicandri Ciufelli, Matteo; Roncadi, Leonardo; Rizzo, Davide; De Vita, Carla; Farneti, Paolo; Todero, Gabriella; Cristofani‐mencacci, Lodovica; Statuti, Erica; Cavallo, Giovanni; Urbanelli, Anastasia; Ferrella, Francesco; Arnone, Flavio; Di Nola, Claudio; Pignataro, Lorenzo; Nava, Nicolò; Russo, Paolo; Savastano, Vincenzo; Masieri, Simonetta; Dell’Era, Valeria; Aluffi Valletti, Paolo; Sovardi, Fabio; Siragusa, Vera; Clemenzi, Veronica; Stolfa, Andrea; Simoni, Edi; Astolfi, Laura. - In: ALLERGY. - ISSN 0105-4538. - (2023). [10.1111/all.15772]

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

Ciofalo Andrea;Cavaliere Carlo;Savastano Vincenzo;Masieri Simonetta;Clemenzi Veronica;Stolfa Andrea;
2023

Abstract

Background 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. Methods 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. Results 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. Conclusions 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.
2023
crswnp; dupilumab; dupireal; asthma, biologics, chronic rhinosinusitis with nasal polyps, dupilumab, smell
01 Pubblicazione su rivista::01a Articolo in rivista
Dupilumab in the treatment of severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP): A multicentric observational Phase IV real-life study (DUPIREAL) / 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; Spanu, Camilla; Porru Davide, Paolo; Lo Verde, Simone; Corbò, Marco; Cantiani, Alessandro; Furno, Daniela; D’Agostino, Giuseppe; D’Auria Leandro, Maria; De Maio, Gabriele; Di Bella Giuseppe, Alberto; Penazzi, Daniele; Mele Dario, Antonio; Di Cesare, Tiziana; Andrea, Rampi; Umberto, Tanzini; Saccardo, Tommaso; Roccuzzo, Giuseppe; Cipolla, Federica; Ragusa, Martina; Grigaliute, Egle; Alicandri Ciufelli, Matteo; Roncadi, Leonardo; Rizzo, Davide; De Vita, Carla; Farneti, Paolo; Todero, Gabriella; Cristofani‐mencacci, Lodovica; Statuti, Erica; Cavallo, Giovanni; Urbanelli, Anastasia; Ferrella, Francesco; Arnone, Flavio; Di Nola, Claudio; Pignataro, Lorenzo; Nava, Nicolò; Russo, Paolo; Savastano, Vincenzo; Masieri, Simonetta; Dell’Era, Valeria; Aluffi Valletti, Paolo; Sovardi, Fabio; Siragusa, Vera; Clemenzi, Veronica; Stolfa, Andrea; Simoni, Edi; Astolfi, Laura. - In: ALLERGY. - ISSN 0105-4538. - (2023). [10.1111/all.15772]
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