Dupilumab-Induced Blood Eosinophilia in Patients With Chronic Rhinosinusitis With Nasal Polyps: Temporal Trends and Correlation With Adverse Events

Eugenio De Corso¹, Claudio Montuori², Ernesto Pasquini³, Ignazio La Mantia⁴, Angelo Ghidini⁵, Carlotta Pipolo⁶, Massimiliano Garzaro⁷, Giancarlo Ottaviano⁸, Veronica Seccia⁹, Andrea Ciofalo¹⁰, Sara Torretta¹¹, Elena Cantone¹², Giulia Danè¹³, Fabio Pagella¹⁴, Daniela Lucidi¹⁵, Gian Luca Fadda¹⁶, Alice Mannocci¹⁷, Carlo Cavaliere¹⁸, Giulio Pagliuca¹⁹, Frank Rikki Mauritz Canevari²⁰, Stefano Settimi², Francesco Bussu²¹, Marco Corbo², Silvia Baroni²², Jacopo Galli²; Dupilumab Italian Study Group

Collaborators, Affiliations

Collaborators

Dupilumab Italian Study Group:
Cecilia Rosso, Francesca Anastasi, Marianna Maffei, Stefania Gallo, Matteo Frascio, Matteo Trimarchi, Camilla Spanu, Davide Paolo Porru, Simone Lo Verde, Alessia Giorli, Mariella Scarano, Mele Dario, Tiziana Di Cesare, Giuseppe D'Agostino, Leandro Maria D'Auria, Gabriele De Maio, Giuseppe Alberto Di Bella, Daniele Penazzi, Luigi Fiorillo, Alberta Rizzuti, Clara Pacilli, Serena Pisciottano, Rampi Andrea, Umberto Tanzini, Tommaso Saccardo, Giuseppe Roccuzzo, Giovanna Stilo, Giuliano Messina, Andrea Zappalà, Matteo Alicandri Ciufelli, Roberto Sannasardo, Costanza Galloni, Davide Rizzo, Carla De Vita, Paolo Farneti, Miriana Picariello, Leonardo Zini, Giovanni Cavallo, Anastasia Urbanelli, Francesco Ferrella, Letizia Nitro, Claudio Di Nola, Lorenzo Pignataro, Nicolò Nava, Paolo Russo, Riccardo Caramia, Simonetta Masieri, Valeria Dell'Era, Paolo Aluffi Valletti, Fabio Sovardi, Vera Siragusa, Veronica Clemenzi, Andrea Stolfa, Claudia Crescio, Luca Mureddu, Riccardo Bernardi E Sonny Zampollo

Affiliations

¹ Otorhinolaryngology Unit, A. Gemelli University Hospital Foundation IRCCS, Rome, Italy. Electronic address: eugenio.decorso@policlinicogemelli.it.
² Department of Head, Neck and Sensory Organs, Catholic University of The Sacred Heart, Rome, Italy.
³ Otorhinolaryngology Unit, Ospedale Bellaria Dip Chirurgie Specialistiche AUSL, Bologna, Italy.
⁴ Department of Medical-Surgical Sciences and Advanced Technologies"G.F. Ingrassia", Director of E.N.T. Unit, P.O. "G. Rodolico", University of Catania, Catania, Italy.
⁵ ENT Department, Azienda USL Reggio Emilia-IRCCS, Reggio Emilia, Italy.
⁶ Otorhinolaryngology Unit, ASST Santi Paolo e Carlo Hospital, Milan, Italy; Department of Health Sciences, Università degli Studi di Milano, Milan, Italy.
⁷ Department of Otorhinolaryngology, Rhinology Unit, Eastern Piedmont University-Maggiore Hospital, Novara, Italy.
⁸ Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy.
⁹ 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.
¹⁰ Rhinology Unit, Department of Sensory Organs, Sapienza University of Rome, Rome, Italy.
¹¹ Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico", Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
¹² Department of Neuroscience, Reproductive and Odontostomatological Sciences-ENT Section, University of Naples Federico II, Naples, Italy; Head and Neck Department-ENT Section, AOU Federico II, Naples, Italy.
¹³ Otorhinolaryngology Unit, Head and Neck Department, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
¹⁴ Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, Pediatric Unit, University of Pavia, Pavia, Italy; Department of Otorhinolaryngology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
¹⁵ Department of Otolaryngology-Head and Neck Surgery, Azienda Ospedaliero Universitaria di Modena, Modena, Italy.
¹⁶ Department of Otorhinolaryngology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Italy.
¹⁷ Department for the Promotion of Human Sciences and Quality of Life, San Raffaele University, Rome, Italy; Clinical and Molecular Epidemiology, IRCCS San Raffaele, Rome, Italy.
¹⁸ Department of Sense Organs, Sapienza University of Rome, Rome, Italy.
¹⁹ Otolaryngology University Unit, "S. M. Goretti Hospital", Latina, Italy.
²⁰ Otorhinolaryngology Unit, IRCCS Policlinico San Martino Genova, Dipartimento DISC Università di Genova, Genova, Italy.
²¹ Department of Medicine, Surgery and Pharmacy, Sassari University, Sassari, Italy; Otolaryngology Division, Sassari University Hospital, Sassari, Italy.
²² Unit of Chemistry, Biochemistry and Molecular Biology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy; Department of Basic Biotechnological Sciences, Intensive Care and Perioperative Clinics, Università Cattolica del Sacro Cuore, Rome, Italy.

PMID: 41177433
DOI: 10.1016/j.jaip.2025.10.032

Observational Study

Dupilumab-Induced Blood Eosinophilia in Patients With Chronic Rhinosinusitis With Nasal Polyps: Temporal Trends and Correlation With Adverse Events

Eugenio De Corso et al. J Allergy Clin Immunol Pract. 2026 Feb.

. 2026 Feb;14(2):482-494.e13.

doi: 10.1016/j.jaip.2025.10.032. Epub 2025 Oct 31.

Authors

Collaborators

Dupilumab Italian Study Group:
Cecilia Rosso, Francesca Anastasi, Marianna Maffei, Stefania Gallo, Matteo Frascio, Matteo Trimarchi, Camilla Spanu, Davide Paolo Porru, Simone Lo Verde, Alessia Giorli, Mariella Scarano, Mele Dario, Tiziana Di Cesare, Giuseppe D'Agostino, Leandro Maria D'Auria, Gabriele De Maio, Giuseppe Alberto Di Bella, Daniele Penazzi, Luigi Fiorillo, Alberta Rizzuti, Clara Pacilli, Serena Pisciottano, Rampi Andrea, Umberto Tanzini, Tommaso Saccardo, Giuseppe Roccuzzo, Giovanna Stilo, Giuliano Messina, Andrea Zappalà, Matteo Alicandri Ciufelli, Roberto Sannasardo, Costanza Galloni, Davide Rizzo, Carla De Vita, Paolo Farneti, Miriana Picariello, Leonardo Zini, Giovanni Cavallo, Anastasia Urbanelli, Francesco Ferrella, Letizia Nitro, Claudio Di Nola, Lorenzo Pignataro, Nicolò Nava, Paolo Russo, Riccardo Caramia, Simonetta Masieri, Valeria Dell'Era, Paolo Aluffi Valletti, Fabio Sovardi, Vera Siragusa, Veronica Clemenzi, Andrea Stolfa, Claudia Crescio, Luca Mureddu, Riccardo Bernardi E Sonny Zampollo

Affiliations

¹ Otorhinolaryngology Unit, A. Gemelli University Hospital Foundation IRCCS, Rome, Italy. Electronic address: eugenio.decorso@policlinicogemelli.it.
² Department of Head, Neck and Sensory Organs, Catholic University of The Sacred Heart, Rome, Italy.
³ Otorhinolaryngology Unit, Ospedale Bellaria Dip Chirurgie Specialistiche AUSL, Bologna, Italy.
⁴ Department of Medical-Surgical Sciences and Advanced Technologies"G.F. Ingrassia", Director of E.N.T. Unit, P.O. "G. Rodolico", University of Catania, Catania, Italy.
⁵ ENT Department, Azienda USL Reggio Emilia-IRCCS, Reggio Emilia, Italy.
⁶ Otorhinolaryngology Unit, ASST Santi Paolo e Carlo Hospital, Milan, Italy; Department of Health Sciences, Università degli Studi di Milano, Milan, Italy.
⁷ Department of Otorhinolaryngology, Rhinology Unit, Eastern Piedmont University-Maggiore Hospital, Novara, Italy.
⁸ Department of Neurosciences, Otolaryngology Section, University of Padova, Padova, Italy.
⁹ 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.
¹⁰ Rhinology Unit, Department of Sensory Organs, Sapienza University of Rome, Rome, Italy.
¹¹ Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico", Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
¹² Department of Neuroscience, Reproductive and Odontostomatological Sciences-ENT Section, University of Naples Federico II, Naples, Italy; Head and Neck Department-ENT Section, AOU Federico II, Naples, Italy.
¹³ Otorhinolaryngology Unit, Head and Neck Department, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
¹⁴ Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, Pediatric Unit, University of Pavia, Pavia, Italy; Department of Otorhinolaryngology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
¹⁵ Department of Otolaryngology-Head and Neck Surgery, Azienda Ospedaliero Universitaria di Modena, Modena, Italy.
¹⁶ Department of Otorhinolaryngology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Italy.
¹⁷ Department for the Promotion of Human Sciences and Quality of Life, San Raffaele University, Rome, Italy; Clinical and Molecular Epidemiology, IRCCS San Raffaele, Rome, Italy.
¹⁸ Department of Sense Organs, Sapienza University of Rome, Rome, Italy.
¹⁹ Otolaryngology University Unit, "S. M. Goretti Hospital", Latina, Italy.
²⁰ Otorhinolaryngology Unit, IRCCS Policlinico San Martino Genova, Dipartimento DISC Università di Genova, Genova, Italy.
²¹ Department of Medicine, Surgery and Pharmacy, Sassari University, Sassari, Italy; Otolaryngology Division, Sassari University Hospital, Sassari, Italy.
²² Unit of Chemistry, Biochemistry and Molecular Biology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy; Department of Basic Biotechnological Sciences, Intensive Care and Perioperative Clinics, Università Cattolica del Sacro Cuore, Rome, Italy.

PMID: 41177433
DOI: 10.1016/j.jaip.2025.10.032

Abstract

Background: Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) treated with dupilumab may experience an increase in blood absolute eosinophil count (AEC). However, the onset and temporal pattern of dupilumab-induced blood eosinophilia (DIBE) have not been thoroughly investigated in real life.

Objective: To evaluate DIBE prevalence and temporal pattern in patients with CRSwNP, and to determine associations between DIBE and adverse events (AEs), patients' clinical characteristics, and treatment outcomes.

Methods: This is a multicentric historical prospective observational study conducted across 14 Italian centers of the DUPIREAL network. DIBE onset and temporal pattern, clinical characteristics, CRSwNP outcomes, and AEs were analyzed. DIBE was defined as an AEC increased by 50% from baseline and at least >500 cells/mm³, or AEC >1500 cells/mm³.

Results: A total of 564 patients with CRSwNP were enrolled. Mean AEC peaked at 3 months and declined by 12 months. Among patients developing DIBE (48.2%), 3 distinct temporal patterns were identified based on onset and duration: early-onset temporary (group 1, 30.7% patients), early-onset persistent (group 2, 14.4% patients), and late-onset (group 3, 3.2% patients). Asthma prevalence (P < .001), use of asthma inhalers (P < .001), and previous oral corticosteroid use (P < .045) were greater in patients with DIBE (group 1-3) than in patients without DIBE (group 0). DIBE >1500 cells/mm³ was associated with a higher risk of developing mild AEs (P < 0.001). DIBE occurrence did not influence dupilumab outcomes in patients with CRSwNP.

Conclusions: Distinct DIBE patterns have been identified in patients with CRSwNP based on eosinophilia temporal trends. DIBE was mainly observed in patients with comorbid asthma and previous use of systemic steroids. The findings confirm that DIBE is a mostly transient and harmless phenomenon associated only with mild AEs.

Keywords: Adverse events; Asthma; CRSwNP; Dupilumab; Eosinophilia; Safety; Systemic steroids; Temporal pattern.

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Dupilumab-Induced Blood Eosinophilia in Patients With Chronic Rhinosinusitis With Nasal Polyps: Temporal Trends and Correlation With Adverse Events

Collaborators

Affiliations

Dupilumab-Induced Blood Eosinophilia in Patients With Chronic Rhinosinusitis With Nasal Polyps: Temporal Trends and Correlation With Adverse Events

Authors

Collaborators

Affiliations

Abstract

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MeSH terms

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LinkOut - more resources

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Medical