{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T10:07:03Z","timestamp":1769940423882,"version":"3.49.0"},"reference-count":35,"publisher":"MDPI AG","issue":"13","license":[{"start":{"date-parts":[[2023,6,29]],"date-time":"2023-06-29T00:00:00Z","timestamp":1687996800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Open Access Publication Fund of the University of Freiburg","award":["OA-23-205"],"award-info":[{"award-number":["OA-23-205"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Chronic rhinosinusitis with nasal polyps (CRSwNP) is a mainly type-2-driven inflammatory disease that is often refractory to medical and surgical treatment and characterized by a high rate of recurrence. Monoclonal antibodies have been approved for severe refractory CRSwNP. Randomized controlled trials (RCT) have shown significant improvement in objective and subjective parameters. The results of these RCTs cannot necessarily be transferred to daily routine. The purpose of this retrospective study is to evaluate the treatment effects of biologics in patients with CRSwNP in a real-life setting. Patients treated with one of the approved biologics since July 2020 with at least 6 months follow-up were included in the study. Changes in SNOT-22 and nasal polyp score (NPS), as well as subjective change in sense of smell, number of sinus surgeries prior to and during treatment, comorbidities, discontinuation or change of monoclonal antibody and adverse events were evaluated. Thirty-three patients were included in this study. The mean SNOT-22 score and NPS improved significantly. The subjective assessment of sense of smell showed an improvement in 81.8% of patients. The monoclonal antibody had to be changed in seven patients. No severe adverse events occurred during the initiation of the treatment and follow-up. Biologics can be a treatment option in patients with severe refractory CRSwNP, showing significant improvements in quality of life, symptoms and polyp scores in randomized controlled trials and clinical routine with rare complications. Further research is needed to evaluate possible biomarkers, interdose interval prolongation and long-term safety.<\/jats:p>","DOI":"10.3390\/jcm12134374","type":"journal-article","created":{"date-parts":[[2023,6,29]],"date-time":"2023-06-29T01:53:57Z","timestamp":1688003637000},"page":"4374","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Real Life Observational Study of Treatment Success of Monoclonal Antibodies for Refractory Chronic Rhinosinusitis with Nasal Polyps"],"prefix":"10.3390","volume":"12","author":[{"given":"Kathrin","family":"Gerstacker","sequence":"first","affiliation":[{"name":"Department of Oto-Rhino-Laryngology, Medical Center\u2014University of Freiburg, Killianstr. 5, 79106 Freiburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manuel Christoph","family":"Ketterer","sequence":"additional","affiliation":[{"name":"Department of Oto-Rhino-Laryngology, Medical Center\u2014University of Freiburg, Killianstr. 5, 79106 Freiburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Till Fabian","family":"Jakob","sequence":"additional","affiliation":[{"name":"Department of Oto-Rhino-Laryngology, Medical Center\u2014University of Freiburg, Killianstr. 5, 79106 Freiburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0982-1836","authenticated-orcid":false,"given":"Tanja","family":"Hildenbrand","sequence":"additional","affiliation":[{"name":"Department of Oto-Rhino-Laryngology, Medical Center\u2014University of Freiburg, Killianstr. 5, 79106 Freiburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2023,6,29]]},"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":"179","DOI":"10.1080\/00016480252814199","article-title":"The estimated incidence of symptomatic nasal polyps","volume":"122","author":"Larsen","year":"2002","journal-title":"Acta Otolaryngol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"625","DOI":"10.1177\/000348940311200709","article-title":"Prevalence of nasal polyps in adults: The Skovde population-based study","volume":"112","author":"Johansson","year":"2003","journal-title":"Ann. Otol. Rhinol. Laryngol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"717","DOI":"10.1093\/ije\/28.4.717","article-title":"Prevalence of asthma, aspirin intolerance, nasal polyposis and chronic obstructive pulmonary disease in a population-based study","volume":"28","author":"Hedman","year":"1999","journal-title":"Int. J. Epidemiol."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"2812","DOI":"10.1016\/j.jaip.2019.05.009","article-title":"Associations Between Inflammatory Endotypes and Clinical Presentations in Chronic Rhinosinusitis","volume":"7","author":"Stevens","year":"2019","journal-title":"J. Allergy Clin. Immunol. Pract."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"1344","DOI":"10.1016\/j.jaci.2016.05.041","article-title":"Diversity of T(H) cytokine profiles in patients with chronic rhinosinusitis: A multicenter study in Europe, Asia, and Oceania","volume":"138","author":"Wang","year":"2016","journal-title":"J. Allergy Clin. Immunol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"86","DOI":"10.1038\/s41572-020-00218-1","article-title":"Adult chronic rhinosinusitis","volume":"6","author":"Bachert","year":"2020","journal-title":"Nat. Rev. Dis. Prim."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1111\/pai.13619","article-title":"Type 2 inflammation in cystic fibrosis: New insights","volume":"33","author":"Manti","year":"2022","journal-title":"Pediatr. Allergy Immunol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"213","DOI":"10.1002\/alr.22741","article-title":"International consensus statement on allergy and rhinology: Rhinosinusitis 2021","volume":"11","author":"Orlandi","year":"2021","journal-title":"Int. Forum Allergy Rhinol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"1543","DOI":"10.1016\/j.jaci.2018.03.004","article-title":"Endotype-driven care pathways in patients with chronic rhinosinusitis","volume":"141","author":"Bachert","year":"2018","journal-title":"J. Allergy Clin. Immunol."},{"key":"ref_11","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_12","doi-asserted-by":"crossref","first-page":"1141","DOI":"10.1016\/S2213-2600(21)00097-7","article-title":"Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): A randomised, double-blind, placebo-controlled, phase 3 trial","volume":"9","author":"Han","year":"2021","journal-title":"Lancet Respir. Med."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"595","DOI":"10.1016\/j.jaci.2020.05.032","article-title":"Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials","volume":"146","author":"Gevaert","year":"2020","journal-title":"J. Allergy Clin. Immunol."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"53","DOI":"10.5414\/ALX02166E","article-title":"Use of biologicals in allergic and type-2 inflammatory diseases during the current COVID-19 pandemic: Position paper of Arzteverband Deutscher Allergologen (AeDA)(A), Deutsche Gesellschaft fur Allergologie und Klinische Immunologie (DGAKI)(B), Gesellschaft fur Padiatrische Allergologie und Umweltmedizin (GPA)(C), Osterreichische Gesellschaft fur Allergologie und Immunologie (OGAI)(D), Luxemburgische Gesellschaft fur Allergologie und Immunologie (LGAI)(E), Osterreichische Gesellschaft fur Pneumologie (OGP)(F) in co-operation with the German, Austrian, and Swiss ARIA groups(G), and the European Academy of Allergy and Clinical Immunology (EAACI)(H)","volume":"4","author":"Klimek","year":"2020","journal-title":"Allergol. Select"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"511","DOI":"10.1055\/a-1197-0136","article-title":"Positionspapier: Anwendung von Biologika bei chronischer Rhinosinusitis mit Polyposis nasi (CRSwNP) im deutschen Gesundheitssystem\u2014Empfehlungen des \u00c4rzteverbandes Deutscher Allergologen (AeDA) und der AGs Klinische Immunologie, Allergologie und Umweltmedizin und Rhinologie und Rhinochirurgie der Deutschen Gesellschaft f\u00fcr HNO-Heilkunde, Kopf- und Halschirurgie (DGHNOKHC)","volume":"99","author":"Klimek","year":"2020","journal-title":"Laryngorhinootologie"},{"key":"ref_16","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_17","doi-asserted-by":"crossref","first-page":"855","DOI":"10.1055\/a-1908-3074","article-title":"Empfehlungen zur \u00dcberpr\u00fcfung der Wirksamkeit und Verlaufsdokumentation von Dupilumab bei chronischer Rhinosinusitis mit Nasenpolypen (CRSwNP) im deutschen Gesundheitssystem","volume":"101","author":"Klimek","year":"2022","journal-title":"Laryngorhinootologie"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"89","DOI":"10.1055\/a-2003-4730","article-title":"Empfehlungen zur \u00dcberpr\u00fcfung der Wirksamkeit und Verlaufsdokumentation von Mepolizumab bei chronischer Rhinosinusitis mit Nasenpolypen (CRSwNP) im deutschen Gesundheitssystem\u2014Empfehlungen des \u00c4rzteverbandes Deutscher Allergologen (AeDA) und der AGs Klinische Immunologie, Allergologie und Umweltmedizin und Rhinologie und Rhinochirurgie der Deutschen Gesellschaft f\u00fcr HNO-Heilkunde, Kopf- und Halschirurgie (DGHNOKHC)","volume":"102","author":"Klimek","year":"2023","journal-title":"Laryngorhinootologie"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"972","DOI":"10.1002\/alr.21408","article-title":"SNOT-22 quality of life domains differentially predict treatment modality selection in chronic rhinosinusitis","volume":"4","author":"DeConde","year":"2014","journal-title":"Int. Forum Allergy Rhinol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"2433","DOI":"10.1007\/s00405-021-07019-6","article-title":"Cross-cultural adaptation and validation of the 22-item sinonasal outcome test (SNOT-22) in German-speaking patients: A prospective, multicenter cohort study","volume":"279","author":"Albrecht","year":"2022","journal-title":"Eur. Arch. Otorhinolaryngol."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"447","DOI":"10.1111\/j.1749-4486.2009.01995.x","article-title":"Psychometric validity of the 22-item Sinonasal Outcome Test","volume":"34","author":"Hopkins","year":"2009","journal-title":"Clin. Otolaryngol."},{"key":"ref_22","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_23","doi-asserted-by":"crossref","first-page":"595","DOI":"10.1001\/archotol.1997.01900060037006","article-title":"Glucocorticoid treatment for nasal polyps. The use of topical budesonide powder, intramuscular betamethasone, and surgical treatment","volume":"123","author":"Lildholdt","year":"1997","journal-title":"Arch. Otolaryngol. Head Neck Surg."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"E26","DOI":"10.1002\/lary.28648","article-title":"Cost Utility Analysis of Dupilumab Versus Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyps","volume":"131","author":"Scangas","year":"2021","journal-title":"Laryngoscope"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"135","DOI":"10.1177\/19458924211030486","article-title":"Defining the Efficacy of Omalizumab in Nasal Polyposis: A POLYP 1 and POLYP 2 Subgroup Analysis","volume":"36","author":"Damask","year":"2022","journal-title":"Am. J. Rhinol. Allergy"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"957","DOI":"10.1016\/j.jaci.2021.07.045","article-title":"Long-term efficacy and safety of omalizumab for nasal polyposis in an open-label extension study","volume":"149","author":"Gevaert","year":"2022","journal-title":"J. Allergy Clin. Immunol."},{"key":"ref_27","first-page":"435","article-title":"Real-world-effectiveness of biological treatment for severe chronic rhinosinusitis with nasal polyps","volume":"60","author":"Haxel","year":"2022","journal-title":"Rhinology"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"1741","DOI":"10.1007\/s00405-022-07679-y","article-title":"Dupilumab (Dupixent((R))) tends to be an effective therapy for uncontrolled severe chronic rhinosinusitis with nasal polyps: Real data of a single-centered, retrospective single-arm longitudinal study from a university hospital in Germany","volume":"280","author":"Jansen","year":"2023","journal-title":"Eur. Arch. Otorhinolaryngol."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"736","DOI":"10.1159\/000514262","article-title":"Real-Life Experience of Monoclonal Antibody Treatments in Chronic Rhinosinusitis with Nasal Polyposis","volume":"182","author":"Meier","year":"2021","journal-title":"Int. Arch. Allergy Immunol."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"185","DOI":"10.1186\/s12931-021-01775-z","article-title":"Real-life evidence of low-dose mepolizumab efficacy in EGPA: A case series","volume":"22","author":"Detoraki","year":"2021","journal-title":"Respir. Res."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"516","DOI":"10.1177\/1945892420972326","article-title":"Effects of Omalizumab Treatment in Patients With Recalcitrant Nasal Polyposis and Mild Asthma: A Multicenter Retrospective Study","volume":"35","author":"Miguel","year":"2021","journal-title":"Am. J. Rhinol. Allergy"},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1186\/s40463-022-00570-0","article-title":"Canadian real-world study of access and clinical results using dupilumab for chronic rhinosinusitis with polyps","volume":"51","author":"Kilty","year":"2022","journal-title":"J. Otolaryngol. Head Neck Surg."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"670","DOI":"10.1111\/all.15134","article-title":"Real-life observational cohort verifies high efficacy of dupilumab for chronic rhinosinusitis with nasal polyps","volume":"77","author":"Fokkens","year":"2022","journal-title":"Allergy"},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"100746","DOI":"10.1016\/j.waojou.2023.100746","article-title":"A real-life comparison of pulmonary and nasal outcomes in patients with severe asthma and nasal polyposis treated with T2-biologics","volume":"16","author":"Stergioudi","year":"2023","journal-title":"World Allergy Organ. J."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"386","DOI":"10.1016\/j.anai.2021.05.018","article-title":"Dupilumab in the treatment of nasal polyposis: A retrospective, real-world study","volume":"127","author":"Nowsheen","year":"2021","journal-title":"Ann. Allergy Asthma Immunol."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/12\/13\/4374\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T20:03:22Z","timestamp":1760126602000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/12\/13\/4374"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6,29]]},"references-count":35,"journal-issue":{"issue":"13","published-online":{"date-parts":[[2023,7]]}},"alternative-id":["jcm12134374"],"URL":"https:\/\/doi.org\/10.3390\/jcm12134374","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,6,29]]}}}