{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T13:58:22Z","timestamp":1768312702063,"version":"3.49.0"},"reference-count":30,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2022,5,10]],"date-time":"2022-05-10T00:00:00Z","timestamp":1652140800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>The aim of this study was to evaluate the efficacy of dupilumab in the treatment of severe uncontrolled Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), with or without asthma as add-on therapy with intra-nasal corticosteroids in a real-life setting over the first year of treatment. Our data demonstrated that subcutaneous 300 mg dupilumab administered at home via a pre-filled auto-injector every two weeks, based on indications set by the Italian Medicines Agency, was rapidly effective in reducing the size of polyps, decreasing symptoms of disease, improving quality of life, and recovering olfaction. Significant improvement was observed after only 15 days of treatment, and it progressively increased at 6 and 12 months. Dupilumab was also effective in reducing the local nasal eosinophilic infiltrate, in decreasing the need for surgery and\/or oral corticosteroids, and in improving control of associated comorbidities such as chronic eosinophilic otitis media and bronchial asthma. After 12 months of treatment, 96.5% of patients had a moderate\/excellent response. From our data, it was evident that there was a group of patients that showed a very early response within one month of therapy, another group with early response within six months from baseline, and a last group that improved later within 12 months. The results of this study support the use of dupilumab as an effective option in the current standard of care for patients affected by severe uncontrolled CRSwNP.<\/jats:p>","DOI":"10.3390\/jcm11102684","type":"journal-article","created":{"date-parts":[[2022,5,10]],"date-time":"2022-05-10T08:31:55Z","timestamp":1652171515000},"page":"2684","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":71,"title":["Effectiveness of Dupilumab in the Treatment of Patients with Severe Uncontrolled CRSwNP: A \u201cReal-Life\u201d Observational Study in the First Year of Treatment"],"prefix":"10.3390","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5761-7018","authenticated-orcid":false,"given":"Eugenio","family":"De Corso","sequence":"first","affiliation":[{"name":"Unit of Otorhinolaryngology\u2014Head and Neck Surgery, A. Gemelli Hospital Foundation IRCCS, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0104-1501","authenticated-orcid":false,"given":"Stefano","family":"Settimi","sequence":"additional","affiliation":[{"name":"Unit of Otorhinolaryngology\u2014Head and Neck Surgery, A. Gemelli Hospital Foundation IRCCS, 00168 Rome, Italy"},{"name":"Department of Head and Neck and Sensory Organs, Catholic University of the Sacred Hearth, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2070-0314","authenticated-orcid":false,"given":"Claudio","family":"Montuori","sequence":"additional","affiliation":[{"name":"Department of Head and Neck and Sensory Organs, Catholic University of the Sacred Hearth, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marco","family":"Corb\u00f2","sequence":"additional","affiliation":[{"name":"Department of Head and Neck and Sensory Organs, Catholic University of the Sacred Hearth, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8176-0962","authenticated-orcid":false,"given":"Giulio Cesare","family":"Passali","sequence":"additional","affiliation":[{"name":"Unit of Otorhinolaryngology\u2014Head and Neck Surgery, A. Gemelli Hospital Foundation IRCCS, 00168 Rome, Italy"},{"name":"Department of Head and Neck and Sensory Organs, Catholic University of the Sacred Hearth, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Davide Paolo","family":"Porru","sequence":"additional","affiliation":[{"name":"Department of Head and Neck and Sensory Organs, Catholic University of the Sacred Hearth, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simone","family":"Lo Verde","sequence":"additional","affiliation":[{"name":"Department of Head and Neck and Sensory Organs, Catholic University of the Sacred Hearth, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Camilla","family":"Spanu","sequence":"additional","affiliation":[{"name":"Department of Head and Neck and Sensory Organs, Catholic University of the Sacred Hearth, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniele","family":"Penazzi","sequence":"additional","affiliation":[{"name":"Department of Head and Neck and Sensory Organs, Catholic University of the Sacred Hearth, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giuseppe Alberto","family":"Di Bella","sequence":"additional","affiliation":[{"name":"Department of Head and Neck and Sensory Organs, Catholic University of the Sacred Hearth, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eleonora","family":"Nucera","sequence":"additional","affiliation":[{"name":"Unit of Allergology, A. Gemelli Hospital Foundation IRCCS, 00168 Rome, Italy"},{"name":"Department of Internal Medicine and Geriatrics, Catholic University of the Sacred Hearth, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matteo","family":"Bonini","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Geriatrics, Catholic University of the Sacred Hearth, 00168 Rome, Italy"},{"name":"Unit of Pulmonology, A. Gemelli Hospital Foundation IRCCS, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gaetano","family":"Paludetti","sequence":"additional","affiliation":[{"name":"Unit of Otorhinolaryngology\u2014Head and Neck Surgery, A. Gemelli Hospital Foundation IRCCS, 00168 Rome, Italy"},{"name":"Department of Head and Neck and Sensory Organs, Catholic University of the Sacred Hearth, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacopo","family":"Galli","sequence":"additional","affiliation":[{"name":"Unit of Otorhinolaryngology\u2014Head and Neck Surgery, A. Gemelli Hospital Foundation IRCCS, 00168 Rome, Italy"},{"name":"Department of Head and Neck and Sensory Organs, Catholic University of the Sacred Hearth, 00168 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2022,5,10]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1","DOI":"10.4193\/Rhin20.401","article-title":"European position paper on rhinosinusitis and nasal polyps 2020","volume":"58","author":"Fokkens","year":"2020","journal-title":"Rhinology"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"861","DOI":"10.1002\/alr.21979","article-title":"Prognostic value of nasal cytology and clinical factors in nasal polyps development in patients at risk: Can the beginning predict the end?","volume":"7","author":"Lucidi","year":"2017","journal-title":"Int. Forum Allergy Rhinol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"202","DOI":"10.4193\/Rhin17.028","article-title":"EUFOREA Rhinology Research Forum 2016: Report of the brainstorming sessions on needs and priorities in rhinitis and rhinosinusitis","volume":"55","author":"Hellings","year":"2017","journal-title":"Rhinol. J."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1016\/j.jaci.2020.11.013","article-title":"EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: Definitions and management","volume":"147","author":"Bachert","year":"2021","journal-title":"J. Allergy Clin. Immunol."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"1","DOI":"10.14639\/0392-100X-N1614","article-title":"Biologics for severe uncontrolled chronic rhinosinusitis with nasal polyps: A change management approach. Consensus of the Joint Committee of Italian Society of Otorhinolaryngology on biologics in rhinology","volume":"42","author":"Bellocchi","year":"2022","journal-title":"Acta Otorhinolaryngol. Ital."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"110","DOI":"10.1016\/j.jaci.2012.07.047","article-title":"Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma","volume":"131","author":"Gevaert","year":"2013","journal-title":"J. Allergy Clin. Immunol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"113","DOI":"10.14639\/0392-100X-N0364","article-title":"Prognostic value of the Sinonasal Outcome Test 22 (SNOT-22) in chronic rhinosinusitis","volume":"40","author":"Gallo","year":"2020","journal-title":"Acta Otorhinolaryngol. Ital."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"303","DOI":"10.1016\/j.healthpol.2004.02.008","article-title":"Measuring health status: Information for primary care decision making","volume":"71","author":"Kind","year":"2005","journal-title":"Health Policy"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1186\/2045-7022-1-2","article-title":"Diagnostic tools in Rhinology EAACI position paper","volume":"1","author":"Scadding","year":"2011","journal-title":"Clin. Transl. Allergy"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"215265672098856","DOI":"10.1177\/2152656720988565","article-title":"Evaluation of In-Office Cryoablation of Posterior Nasal Nerves for the Treatment of Rhinitis","volume":"12","author":"Stuyt","year":"2021","journal-title":"Allergy Rhinol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1111\/j.1365-2222.1988.tb02840.x","article-title":"Symptom scores as measures of the severity of rhinitis","volume":"18","author":"Linder","year":"1988","journal-title":"Clin. Exp. Allergy"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"773","DOI":"10.1007\/s00405-021-06848-9","article-title":"Smell impairment in patients with chronic rhinosinusitis: A real-life study","volume":"279","author":"Passali","year":"2022","journal-title":"Eur. Arch. Oto-Rhino-Laryngol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1","DOI":"10.4193\/Rhino16.248","article-title":"Position paper on olfactory dysfunction","volume":"54","author":"Hummel","year":"2017","journal-title":"Rhinol. J."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"237","DOI":"10.1007\/s00405-006-0173-0","article-title":"Normative data for the \u201cSniffin\u2019 Sticks\u201d including tests of odor identification, odor discrimination, and olfactory thresholds: AN upgrade based on a group of more than 3,000 subjects","volume":"264","author":"Hummel","year":"2007","journal-title":"Eur. Arch. Oto-Rhino-Laryngol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1667","DOI":"10.1097\/00002030-199813000-00015","article-title":"Taste and smell complaints in HIV-infected patients","volume":"12","author":"Heald","year":"1998","journal-title":"AIDS"},{"key":"ref_16","doi-asserted-by":"crossref","unstructured":"Huvanandana, J., Nguyen, C.D., Foster, J.M., Frey, U., Reddel, H.K., and Thamrin, C. (2021). Novel Methods of Measuring Adherence Patterns Reveal Adherence Phenotypes with Distinct Asthma Outcomes. Ann. Am. Thorac. Soc., Epub ahead of print.","DOI":"10.1513\/AnnalsATS.202106-653OC"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"557","DOI":"10.1002\/alr.21519","article-title":"Nasal lavage levels of granulocyte-macrophage colony-stimulating factor and chronic nasal hypereosinophilia","volume":"5","author":"Baroni","year":"2015","journal-title":"Int. Forum Allergy Rhinol."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"617","DOI":"10.1002\/alr.21348","article-title":"Nasal fluid release of eotaxin-3 and eotaxin-2 in persistent sinonasal eosinophilic inflammation","volume":"4","author":"Baroni","year":"2014","journal-title":"Int. Forum Allergy Rhinol."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"174","DOI":"10.4193\/Rhino10.133","article-title":"Nasal lavage CCL24 levels correlate with eosinophils trafficking and symptoms in chronic sino-nasal eosinophilic inflammation","volume":"49","author":"Baroni","year":"2011","journal-title":"Rhinol. J."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"38","DOI":"10.14639\/0392-100X-1417","article-title":"Non-surgical management of chronic rhinosinusitis with nasal polyps based on clinical-cytological grading: A precision medicine-based approach","volume":"37","author":"Gelardi","year":"2017","journal-title":"Acta Otorhinolaryngol. Ital."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"456","DOI":"10.1016\/j.anl.2010.11.016","article-title":"Diagnostic criteria of eosinophilic otitis media, a newly recognized middle ear disease","volume":"38","author":"Iino","year":"2011","journal-title":"Auris Nasus Larynx"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"277","DOI":"10.14639\/0392-100X-N1184","article-title":"Cross-cultural adaptation and Italian validation of chronic otitis media outcome test 15 (COMOT-15)","volume":"41","author":"Cavaliere","year":"2021","journal-title":"Acta Otorhinolaryngol. Ital."},{"key":"ref_23","doi-asserted-by":"crossref","unstructured":"De Corso, E., Montuori, C., Settimi, S., Mele, D.A., Cantiani, A., Corb\u00f2, M., Cantone, E., Paludetti, G., and Galli, J. (2022). Efficacy of Biologics on Refractory Eosinophilic Otitis Media Associated with Bronchial Asthma or Severe Uncontrolled CRSwNP. J. Clin. Med., 11.","DOI":"10.3390\/jcm11040926"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1177\/1945892420936196","article-title":"Predictors of Disease Control After Endoscopic Sinus Surgery Plus Long-Term Local Corticosteroids in CRSwNP","volume":"35","author":"Settimi","year":"2021","journal-title":"Am. J. Rhinol. Allergy"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"551","DOI":"10.1002\/lary.27576","article-title":"Antileukotrienes improve naso-ocular symptoms and biomarkers in patients with NARES and asthma","volume":"129","author":"Anzivino","year":"2019","journal-title":"Laryngoscope"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"127","DOI":"10.2147\/JAA.S290424","article-title":"Burden of Disease in Chronic Rhinosinusitis with Nasal Polyps","volume":"14","author":"Bachert","year":"2021","journal-title":"J. Asthma Allergy"},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"449","DOI":"10.1177\/1945892420961964","article-title":"Surgery in Nasal Polyp Patients: Outcome After a Minimum Observation of 10 Years","volume":"35","author":"Vlaminck","year":"2021","journal-title":"Am. J. Rhinol. Allergy"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"469","DOI":"10.1001\/jama.2015.19330","article-title":"Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis","volume":"315","author":"Bachert","year":"2016","journal-title":"JAMA"},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"1638","DOI":"10.1016\/S0140-6736(19)31881-1","article-title":"Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): Results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials","volume":"394","author":"Bachert","year":"2019","journal-title":"Lancet"},{"key":"ref_30","first-page":"670","article-title":"Real-life observational cohort verifies high efficacy of dupilumab for chronic rhinosinusitis with nasal polyps","volume":"77","author":"Fokkens","year":"2021","journal-title":"Allergy"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/11\/10\/2684\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T23:08:42Z","timestamp":1760137722000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/11\/10\/2684"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,5,10]]},"references-count":30,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2022,5]]}},"alternative-id":["jcm11102684"],"URL":"https:\/\/doi.org\/10.3390\/jcm11102684","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,5,10]]}}}