Clinical and Molecular Allergy (May 2022)
Effectiveness and safety of dupilumab in patients with chronic rhinosinusitis with nasal polyps and associated comorbidities: a multicentric prospective study in real life
- Eustachio Nettis,
- Luisa Brussino,
- Vincenzo Patella,
- Laura Bonzano,
- Aikaterini Detoraki,
- Elisabetta Di Leo,
- Maria Maddalena Sirufo,
- Cristiano Caruso,
- Fabio Lodi Rizzini,
- Mariaelisabetta Conte,
- Mona-Rita Yacoub,
- Massimo Triggiani,
- Erminia Ridolo,
- Luigi Macchia,
- Giovanni Rolla,
- Raffaele Brancaccio,
- Amato De Paulis,
- Giuseppe Spadaro,
- Danilo Di Bona,
- Angela Maria D’Uggento,
- Lia Ginaldi,
- Francesco Gaeta,
- Eleonora Nucera,
- Kliljeda Jaubashi,
- Danilo Villalta,
- Lorenzo Dagna,
- Domenico Ciotta,
- Francesco Pucciarini,
- Diego Bagnasco,
- Giorgio Celi,
- Fulvia Chieco Bianchi,
- Lorenzo Cosmi,
- Maria Teresa Costantino,
- Maria Angiola Crivellaro,
- Simona D’Alò,
- Pietro del Biondo,
- Stefano Del Giacco,
- Mario Di Gioacchino,
- Linda Di Pietro,
- Elisabetta Favero,
- Sebastiano Gangemi,
- Gabriella Guarnieri,
- Enrico Heffler,
- Maria Stefania Leto Barone,
- Carla Lombardo,
- Francesca Losa,
- Andrea Matucci,
- Paola Lucia Minciullo,
- Paola Parronchi,
- Giovanni Passalacqua,
- Stefano Pucci,
- Oliviero Rossi,
- Lorenzo Salvati,
- Michele Schiappoli,
- Gianenrico Senna,
- Andrea Vianello,
- Alessandra Vultaggio,
- Yang Baoran,
- Cristoforo Incorvaia,
- Giorgio Walter Canonica
Affiliations
- Eustachio Nettis
- Department of Emergency and Organ Transplantation, School of Allergology and Clinical Immunology, University of Bari Aldo Moro
- Luisa Brussino
- Department of Medical Sciences, University of Turin
- Vincenzo Patella
- Division of Allergy and Clinical Immunology, Department of Medicine ASL Salerno, Santa Maria Della Speranza Hospital
- Laura Bonzano
- Dermatology Unit, Azienda USL-IRCCS di Reggio Emilia
- Aikaterini Detoraki
- Department of Internal Medicine, Clinical Immunology, Clinical Pathology and Infectious Disease, Azienda Ospedaliera Universitaria Federico II
- Elisabetta Di Leo
- Section of Allergy and Clinical Immunology, Unit of Internal Medicine, “F. Miulli” Hospital
- Maria Maddalena Sirufo
- Department of Life, Health and Environmental Sciences, University of L’Aquila
- Cristiano Caruso
- Dipartimento di Scienze Mediche e Chirurgiche, Digestive Disease Center, Fondazione Policlinico A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore
- Fabio Lodi Rizzini
- Facoltà Medicina e Chirurgia, Università Studi Brescia
- Mariaelisabetta Conte
- Struttura Dipartimentale di Immunologia ed Allergologia Azienda Sanitaria Friuli Occidentale, Presidio Ospedaliero di Pordenone
- Mona-Rita Yacoub
- Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Scientific Institute
- Massimo Triggiani
- Division of Allergy and Clinical Immunology, University of Salerno
- Erminia Ridolo
- Department of Medicine and Surgery, University of Parma
- Luigi Macchia
- Department of Emergency and Organ Transplantation, School of Allergology and Clinical Immunology, University of Bari Aldo Moro
- Giovanni Rolla
- Dipartimento di Scienze Mediche, Università Di Torino
- Raffaele Brancaccio
- Dermatology Unit, Azienda USL-IRCCS di Reggio Emilia
- Amato De Paulis
- Department of Internal Medicine, Clinical Immunology, Clinical Pathology and Infectious Disease, Azienda Ospedaliera Universitaria Federico II
- Giuseppe Spadaro
- Department of Internal Medicine, Clinical Immunology, Clinical Pathology and Infectious Disease, Azienda Ospedaliera Universitaria Federico II
- Danilo Di Bona
- Department of Emergency and Organ Transplantation, School of Allergology and Clinical Immunology, University of Bari Aldo Moro
- Angela Maria D’Uggento
- Department of Economics and Finance, University of Bari
- Lia Ginaldi
- Department of Life, Health and Environmental Sciences, University of L’Aquila
- Francesco Gaeta
- Dipartimento di Scienze Mediche e Chirurgiche, Digestive Disease Center, Fondazione Policlinico A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore
- Eleonora Nucera
- Dipartimento di Scienze Mediche e Chirurgiche, Digestive Disease Center, Fondazione Policlinico A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore
- Kliljeda Jaubashi
- Facoltà Medicina e Chirurgia, Università Studi Brescia
- Danilo Villalta
- Struttura Dipartimentale di Immunologia ed Allergologia Azienda Sanitaria Friuli Occidentale, Presidio Ospedaliero di Pordenone
- Lorenzo Dagna
- Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Scientific Institute
- Domenico Ciotta
- Division of Allergy and Clinical Immunology, University of Salerno
- Francesco Pucciarini
- Department of Medicine and Surgery, University of Parma
- Diego Bagnasco
- Clinica Delle Malattie Respiratorie e Allergologia Dipartimento di Medicina Interna (DIMI), Università Degli Studi di Genova IRCCS Ospedale Policlinico San Martino
- Giorgio Celi
- UO Allergologia e Immunologia Clinica, ASST Mantova
- Fulvia Chieco Bianchi
- UOC di Fisiopatologia Respiratoria, Azienda Ospedale-Università di Padova
- Lorenzo Cosmi
- Dipartimento di Medicina Sperimentale e Clinica, Università Degli Studi di Firenze
- Maria Teresa Costantino
- UO Allergologia e Immunologia Clinica, ASST Mantova
- Maria Angiola Crivellaro
- Occupational Health Unit and AllergologyPadova University Hospital, Department of Cardiac Thoracic Vascular Sciences and Public Health, University of Padova
- Simona D’Alò
- UOC Allergologia, Ospedale di Civitanova Marche
- Pietro del Biondo
- Scuola di Specializzazione in Allergologia ed Immunologia Clinica, Università Degli Studi “Gabriele d’Annunzio” di Chieti-Pescara
- Stefano Del Giacco
- Allergologia e Immunologia Clinica - Dipartimento di Scienze Mediche e Sanità Pubblica, Università Degli Studi Di Cagliari
- Mario Di Gioacchino
- Center of Advanced Studies and Technology, G. d’Annunzio University
- Linda Di Pietro
- Dipartimento di Medicina Sperimentale e Clinica, Università Degli Studi di Firenze
- Elisabetta Favero
- Centro Allergologico e Malattie Rare, Dipartimento di Medicina Ospedale Ca’ Foncello
- Sebastiano Gangemi
- Department of Clinical and Experimental Medicine, School and Operative Unit of Allergy and Clinical Immunology, University of Messina
- Gabriella Guarnieri
- Department of Cardiac Thoracic Vascular Science and Public Health, University of Padova
- Enrico Heffler
- Personalized Medicine, Asthma and Allergy, IRCCS Humanitas Research Hospital
- Maria Stefania Leto Barone
- UF Riabilitazione Respiratoria
- Carla Lombardo
- Allergy Unit, Villa Igea Hospital. A.P.S.S. Trento
- Francesca Losa
- UO Allergologia e Immunologia Clinica, ASST Mantova
- Andrea Matucci
- Immunoallergology Unit, Careggi University Hospital
- Paola Lucia Minciullo
- Department of Clinical and Experimental Medicine, School and Operative Unit of Allergy and Clinical Immunology, University of Messina
- Paola Parronchi
- Dipartimento di Medicina Sperimentale e Clinica, Università Degli Studi di Firenze
- Giovanni Passalacqua
- Clinica Delle Malattie Respiratorie e Allergologia Dipartimento di Medicina Interna (DIMI), Università Degli Studi di Genova IRCCS Ospedale Policlinico San Martino
- Stefano Pucci
- UOC Allergologia, Ospedale di Civitanova Marche
- Oliviero Rossi
- Immunoallergology Unit, Careggi University Hospital
- Lorenzo Salvati
- Dipartimento di Medicina Sperimentale e Clinica, Università Degli Studi di Firenze
- Michele Schiappoli
- UOC Allergologia E Asma Center, Azienda Ospedaliera Universitaria Integrata di Verona
- Gianenrico Senna
- UOC Allergologia E Asma Center, Azienda Ospedaliera Universitaria Integrata di Verona
- Andrea Vianello
- Department of Cardiac Thoracic Vascular Science and Public Health, University of Padova
- Alessandra Vultaggio
- Immunoallergology Unit, Careggi University Hospital
- Yang Baoran
- UO Allergologia e Immunologia Clinica, ASST Mantova
- Cristoforo Incorvaia
- Private Practice
- Giorgio Walter Canonica
- Personalized Medicine, Asthma and Allergy, IRCCS Humanitas Research Hospital
- DOI
- https://doi.org/10.1186/s12948-022-00171-2
- Journal volume & issue
-
Vol. 20,
no. 1
pp. 1 – 9
Abstract
Abstract Background Biologics are currently one of the main treatment options for a number of diseases. The IgG4 monoclonal antibody dupilumab targets the Interleukin-4 receptor alpha chain, thus preventing the biological effects of the cytokines IL-4 and IL-13, that are essential for the Th2 response. Several controlled trials showed that dupilumab is effective and safe in patients with atopic dermatitis (AD), severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), thus resulting in approval by regulatory agencies. Aim of the study was to evaluate the efficacy and safety of dupilumab in adult patients with CRSwNP stratified by common overlapping comorbid conditions. Methods We performed a multicenter, observational, prospective study enrolling adult patients with severe CRSwNP who had started dupilumab treatment in the context of standard care from January 2021 to October 2021. Data were collected from twentynine Italian secondary care centers for allergy and clinical immunology, all of which were part of the Italian Society of Allergy, Asthma and Clinical Immunology (SIAAIC). A number of efficacy parameters were used. Patient data were compared using the Wilcoxon test for paired data. All statistical analyses were performed with SPSS version 20 (IBM, Armonk, NY, USA). Results In total, 82 patients with nasal polyposis were identified. A significant improvement was detected for all the applied efficacy parameters, i.e. 22-item Sino-Nasal Outcome Test (SNOT-22) and bilateral endoscopic nasal polyp score (NPS) scores for CRSwNP, Rhinitis Control Scoring System (RCSS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores for allergic perennial rhinitis, Forced Expiratory Volume in the 1st second (FEV1) and Asthma Quality of Life Questionnaire (AQLQ) scores for asthma, Eczema Area and Severity Index (EASI) and Dermatology Life Quality Index (DLQI) scores for AD. A non-significant improvement was also obtained in the Urticaria Activity Score over 7 days (UAS7) for chronic spontaneous urticaria. Treatment with dupilumab was well tolerated. Conclusions These data suggest that dupilumab treatment in patients suffering from CRSwNP and associated comorbidities may be suitable. Such outcome, although confirmation by trials is warranted, suggests the possibility to treat different disorders with a single therapy, with favorable effects especially under the cost-effectiveness aspect.
