Observational Study

. 2023 Oct;78(10):2669-2683.

doi: 10.1111/all.15772. Epub 2023 May 26.

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

Eugenio De Corso¹, Ernesto Pasquini², Matteo Trimarchi³, Ignazio La Mantia⁴, Fabio Pagella⁵, Giancarlo Ottaviano⁶, Massimiliano Garzaro⁷, Carlotta Pipolo⁸, Sara Torretta⁹, Veronica Seccia¹⁰, Elena Cantone¹¹, Andrea Ciofalo¹², Daniela Lucidi¹³, Gian Luca Fadda¹⁴, Pia Clara Pafundi¹⁵, Stefano Settimi¹⁶, Claudio Montuori¹⁶, Francesca Anastasi¹⁷, Giulio Pagliuca¹⁸, Angelo Ghidini¹⁹, Carlo Cavaliere²⁰, Marianna Maffei²¹, Francesco Bussu²², Stefania Gallo²³, Frank Rikki Mauritz Canevari²⁴, Gaetano Paludetti¹⁶, Jacopo Galli¹⁶; Dupireal Italian Study Group

Collaborators, Affiliations

Collaborators

Dupireal Italian Study Group:
Camilla Spanu, Davide Paolo Porru, Simone Lo Verde, Marco Corbò, Alessandro Cantiani, Daniela Furno, Giuseppe D'Agostino, Leandro Maria D'Auria, Gabriele De Maio, Giuseppe Alberto Di Bella, Daniele Penazzi, Dario Antonio Mele, Tiziana Di Cesare, Rampi Andrea, Tanzini Umberto, Tommaso Saccardo, Giuseppe Roccuzzo, Federica Cipolla, Martina Ragusa, Egle Grigaliute, Matteo Alicandri Ciufelli, Leonardo Roncadi, Davide Rizzo, Carla De Vita, Paolo Farneti, Gabriella Todero, Lodovica Cristofani-Mencacci, Erica Statuti, Giovanni Cavallo, Anastasia Urbanelli, Francesco Ferrella, Flavio Arnone, Claudio Di Nola, Lorenzo Pignataro, Nicolò Nava, Paolo Russo, Vincenzo Savastano, Simonetta Masieri, Valeria Dell'Era, Paolo Aluffi Valletti, Fabio Sovardi, Vera Siragusa, Veronica Clemenzi, Andrea Stolfa, Edi Simoni, Laura Astolfi

Affiliations

¹ Otorhinolaryngology Unit, A.Gemelli University Hospital Foundation IRCCS, Rome, Italy.
² Otorhinolaryngology Unit, Ospedale Bellaria Dip Chirurgie Specialistiche AUSL, Bologna, Italy.
³ Otorhinolaryngology Unit, Head and Neck Department, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
⁴ Department of Medical-Surgical Sciences and Advanced Technologies, E.N.T. Unit, P.O. "G. Rodolico", University of Catania, Catania, Italy.
⁵ Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.
⁶ Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy.
⁷ Department of Otorhinolaryngology, Rhinology Unit, Eastern Piedmont University, Maggiore Hospital, Novara, Italy.
⁸ Otorhinolaryngology Unit, Department of Health Sciences, ASST Santi Paolo e Carlo Hospital, Università degli Studi di Milano, Milan, Italy.
⁹ Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico", University of Milan, Milan, Italy.
¹⁰ Otolaryngology, Audiology and Phoniatric Operative Unit, Department of Surgical, Medical, Molecular Pathology and Critical Care Medicine, Azienda Ospedaliera Universitaria Pisana, University of Pisa, Pisa, Italy.
¹¹ Department of Neuroscience, Reproductive and Odontostomatological Sciences-ENT Section, Head and Neck Department-ENT Section, University of Naples Federico II, AOU Federico II, Naples, Italy.
¹² Rhinology Unit, Department of Sensory Organs, Sapienza University of Rome, Rome, Italy.
¹³ Department of Otolaryngology-Head and Neck Surgery, Azienda Ospedaliero Universitaria di Modena, Modena, Italy.
¹⁴ Department of Otorhinolaryngology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Italy.
¹⁵ Epidemiology and Biostatistics Core Facility, Gemelli Science and Technology park, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
¹⁶ Department of Head, Neck and Sensory Organs, Catholic University of The Sacred Heart, Rome, Italy.
¹⁷ Otorhinolaryngology Unit, Ospedale San Giovanni Evangelista, Tivoli, Italy.
¹⁸ Otolaryngology University Unit, "S. M. Goretti Hospital", Latina, Italy.
¹⁹ ENT Department, Azienda USL Reggio Emilia-IRCCS, Reggio Emilia, Italy.
²⁰ Department of Sensory Organs, Sapienza University of Rome, Rome, Italy.
²¹ Otolaryngology Head and Neck Surgery Unit, AORN Ospedali della Colli, Naples, Italy.
²² Division of Otorhinolaryngology, Department of Medicine, Surgery and Pharmacy, Azienda Ospedaliera Universitaria di Sassari, University of Sassary, Sassari, Italy.
²³ Otorinolaryngology Unit, Head and Neck Department, ASST Sette Laghi and UPLOAD Research Center, University of Insubria, Varese, Italy.
²⁴ Otorhinolaryngology Unit, Dipartimento DISC, IRCCS Policlinico San Martino, Università di Genova, Genoa, Italy.

PMID: 37203259
DOI: 10.1111/all.15772

Free article

Observational Study

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

Eugenio De Corso et al. Allergy. 2023 Oct.

Free article

. 2023 Oct;78(10):2669-2683.

doi: 10.1111/all.15772. Epub 2023 May 26.

Authors

Collaborators

Dupireal Italian Study Group:
Camilla Spanu, Davide Paolo Porru, Simone Lo Verde, Marco Corbò, Alessandro Cantiani, Daniela Furno, Giuseppe D'Agostino, Leandro Maria D'Auria, Gabriele De Maio, Giuseppe Alberto Di Bella, Daniele Penazzi, Dario Antonio Mele, Tiziana Di Cesare, Rampi Andrea, Tanzini Umberto, Tommaso Saccardo, Giuseppe Roccuzzo, Federica Cipolla, Martina Ragusa, Egle Grigaliute, Matteo Alicandri Ciufelli, Leonardo Roncadi, Davide Rizzo, Carla De Vita, Paolo Farneti, Gabriella Todero, Lodovica Cristofani-Mencacci, Erica Statuti, Giovanni Cavallo, Anastasia Urbanelli, Francesco Ferrella, Flavio Arnone, Claudio Di Nola, Lorenzo Pignataro, Nicolò Nava, Paolo Russo, Vincenzo Savastano, Simonetta Masieri, Valeria Dell'Era, Paolo Aluffi Valletti, Fabio Sovardi, Vera Siragusa, Veronica Clemenzi, Andrea Stolfa, Edi Simoni, Laura Astolfi

Affiliations

¹ Otorhinolaryngology Unit, A.Gemelli University Hospital Foundation IRCCS, Rome, Italy.
² Otorhinolaryngology Unit, Ospedale Bellaria Dip Chirurgie Specialistiche AUSL, Bologna, Italy.
³ Otorhinolaryngology Unit, Head and Neck Department, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
⁴ Department of Medical-Surgical Sciences and Advanced Technologies, E.N.T. Unit, P.O. "G. Rodolico", University of Catania, Catania, Italy.
⁵ Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.
⁶ Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy.
⁷ Department of Otorhinolaryngology, Rhinology Unit, Eastern Piedmont University, Maggiore Hospital, Novara, Italy.
⁸ Otorhinolaryngology Unit, Department of Health Sciences, ASST Santi Paolo e Carlo Hospital, Università degli Studi di Milano, Milan, Italy.
⁹ Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico", University of Milan, Milan, Italy.
¹⁰ Otolaryngology, Audiology and Phoniatric Operative Unit, Department of Surgical, Medical, Molecular Pathology and Critical Care Medicine, Azienda Ospedaliera Universitaria Pisana, University of Pisa, Pisa, Italy.
¹¹ Department of Neuroscience, Reproductive and Odontostomatological Sciences-ENT Section, Head and Neck Department-ENT Section, University of Naples Federico II, AOU Federico II, Naples, Italy.
¹² Rhinology Unit, Department of Sensory Organs, Sapienza University of Rome, Rome, Italy.
¹³ Department of Otolaryngology-Head and Neck Surgery, Azienda Ospedaliero Universitaria di Modena, Modena, Italy.
¹⁴ Department of Otorhinolaryngology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Italy.
¹⁵ Epidemiology and Biostatistics Core Facility, Gemelli Science and Technology park, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
¹⁶ Department of Head, Neck and Sensory Organs, Catholic University of The Sacred Heart, Rome, Italy.
¹⁷ Otorhinolaryngology Unit, Ospedale San Giovanni Evangelista, Tivoli, Italy.
¹⁸ Otolaryngology University Unit, "S. M. Goretti Hospital", Latina, Italy.
¹⁹ ENT Department, Azienda USL Reggio Emilia-IRCCS, Reggio Emilia, Italy.
²⁰ Department of Sensory Organs, Sapienza University of Rome, Rome, Italy.
²¹ Otolaryngology Head and Neck Surgery Unit, AORN Ospedali della Colli, Naples, Italy.
²² Division of Otorhinolaryngology, Department of Medicine, Surgery and Pharmacy, Azienda Ospedaliera Universitaria di Sassari, University of Sassary, Sassari, Italy.
²³ Otorinolaryngology Unit, Head and Neck Department, ASST Sette Laghi and UPLOAD Research Center, University of Insubria, Varese, Italy.
²⁴ Otorhinolaryngology Unit, Dipartimento DISC, IRCCS Policlinico San Martino, Università di Genova, Genoa, Italy.

PMID: 37203259
DOI: 10.1111/all.15772

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.

Keywords: asthma; biologics; chronic rhinosinusitis with nasal polyps; dupilumab; smell.

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References

REFERENCES

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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

References

REFERENCES

Publication types

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Medical