BACKGROUND: Pivotal studies with dupilumab demonstrated clinically relevant improvements in nasal polyp score, symptom score, and quality-of-life score in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). OBJECTIVE: We evaluated the effectiveness of dupilumab in a large-scale CRSwNP cohort from 6 European tertiary-care centers. METHODOLOGY: Nasal polyp score, Sinonasal Outcome Test 22 score, visual analog scale for total sinus symptoms, loss of smell, and nasal blockage, and Asthma Control Test (ACT) score were collected from hospital records and assessed at baseline and again at 24 and 52 weeks' treatment with dupilumab in CRSwNP patients. Treatment effectiveness was evaluated in relation to demographic and lifestyle factors, sinus surgery history, presence of comorbidities, and blood eosinophil counts (BEC). Treatment response was evaluated according to European Forum for Research and Education in Allergy and Airway Diseases (EUFOREA) 2021 criteria. RESULTS: All patient outcomes improved at 24 and 52 weeks' treatment compared to baseline. Dupilumab showed effectiveness independent of age, sex, body mass index, smoking status, prior sinus surgery, presence of asthma, nonsteroidal anti-inflammatory drug-exacerbated respiratory disease, allergy, or baseline BEC. A total of 92.5% and 94.4% showed an improvement in at least 1 EUFOREA criterion at 24 and 52 weeks, respectively; 54.4% and 68.2% met all 4 of the more stringent EUFOREA criteria at 24 and 52 weeks, respectively. CONCLUSIONS: Real-world evaluation of dupilumab effectiveness demonstrates a robust and sustained response in at least two thirds of patients at 52 weeks' treatment. Favorable treatment response was independent of the number of sinus surgery procedures, major comorbidities, or baseline systemic levels of type 2 inflammation.

Allergy and Clinical Immunology Research Group Department of Microbiology Immunology and Transplantation Katholieke Universiteit Leuven Leuven Belgium; Department of Respiratory Medicine 1st Faculty of Medicine Charles University and Thomayer Hospital Prague Czech Republic; Department of Clinical Pharmacy and Pharmacology University Groningen University Medical Center Groningen Groningen The Netherlands

Department of General ORL Head and Neck Surgery Medical University of Graz Graz Austria

Department of Oral and Maxillofacial Sciences Sapienza University Rome Italy

Department of Otorhinolaryngology and Head Neck Surgery Amsterdam University Medical Centres Amsterdam The Netherlands

Department of Otorhinolaryngology Head and Neck Surgery Vienna General Hospital Medical University of Vienna Vienna Austria

Department of Otorhinolaryngology Universitätsklinikum Düsseldorf Dusseldorf Germany

Department of Otorhinolaryngology Upper Airways Research Laboratory Ghent University Ghent Belgium; Clinic for ENT diseases and Head and Neck Surgery University Clinic Münster Münster Germany

Department of Sense Organs Sapienza University Rome Italy

Galenus Health Hasselt Belgium

Otorhinolaryngology Head and Neck Department Huriez Hospital Centre Hospitalier Universitaire Lille Lille France

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