Biologics in Chronic Rhinosinusitis With Nasal Polyposis

Ki vehet részt

• Age > 18 years
• Confirmed diagnosis of chronic rhinosinusitis with nasal polyposis using ICAR-21 (International Consensus Statement 20215) criteria
• Bilateral nasal polyposis visible on sinonasal endoscopy
• Nasal polyp score > 5
• Baseline SNOT-22 total score > 30
• Patient elects biologic therapy for the management of CRSwNP
• Capable of receiving all 3 biologic therapy medications
• Treatment with intranasal mometasone ≥200 μg. once daily (or equivalent of another intranasal corticosteroid) for 1-month prior to baseline visit

Ki nem vehet részt

• Endoscopic sinus surgery within 6-months preceding enrollment / randomization
• Oral corticosteroid use within 30-days preceding enrollment / randomization
• Any previous treatment with any of the 3 biologic medications
• Comorbid atopic dermatitis, urticaria, or any other condition that would require a specific biologic per the standard of care
• Comorbid systemic inflammatory disorders (e.g., GPA, EGPA, Sarcoidosis, SLE)
• Serum IgE level outside the dosing range for omalizumab (i.e., <30 IU/ml. or a weight-based dose with insufficient data to determine dose as per FDA dosing chart)
• Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks for participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study
• Inability or unwillingness of a participant to give written informed consent or comply with study protocol
• Currently pregnant or plan to become pregnant within the 6 months after enrollment / randomization
• Comorbid cystic fibrosis, CVID, or ciliary dyskinesia