Patients with severe uncontrolled CRSwNP respond to biologics in the real world
Reviewed by Richard (Wei Chern) Gan

Clinical trials have demonstrated that biologics are effective in treating patients with chronic rhinosinusitis with nasal polyps (CRSwNP). This multicentre (15 tertiary care centres in France) observational prospective cohort study aims to examine the effectiveness of biologics in treating CRSwNP in the ‘real world’, outside a clinical trial. Patients who received biologics for treatment of CRSwNP were included. The biologics agent (dupilumab or mepolizumab at clinician’s discretion) used was prescribed according to marketing approval in France: age >18 years, severe CRSwNP uncontrolled with medical treatment (intranasal corticosteroids and at least two to three cycles of oral corticosteroid (OCS) over the last year) and endoscopic sinus surgery (ESS). There was no specific quality-of-life or extent-of-surgery criteria. Excluded patients: those on other immunosuppressive therapy, long-term corticosteroid for a separate condition, pregnant or breastfeeding, on a biologic in previous six months not for asthma and hypersensitivity to humanised antibodies. In total, 326 patients were included (August 2021 to December 2022). Asthma was present in 76.1%. Median time between last ESS and initiation of biologics was five years. A total of 293 patients had dupilumab while 33 patients had mepolizumab. QoL improved significantly from baseline (median SNOT-22 60.5) to month three (median SNOT-22 26.0). SNOT-22 score stayed low from month three to month 18. There was significant improvement in visual analogue scale (VAS) and nasal polyp scores (NPS) from baseline to month three and remained low to month 18. Of 272 patients, 59% were excellent responders at month six. Of 184 patients, 66% were excellent responders at month 12 and 68% at month 18. In the univariable analysis, five parameters are potentially associated with excellent response at six months: age, history of allergy, type of biologic, duration of CRSwNP prior to biologic and baseline blood eosinophil count. In the multivariable analysis, baseline blood eosinophil count and type of biologic were associated with an excellent response. Excellent responders were defined as: decrease of NPS by >1/8, smell VAS increase >16.7/100, SNOT-22 reduction >20/100, no need for OCS, no need for surgery, and complete control of comorbidities between visits. The authors caution the interpretation of the result of association of type of biologic with an excellent response as the numbers treated with dupilumab vs. mepolizumab were disproportionate. Furthermore, the high prevalence of asthma in this cohort may bias the association of blood eosinophil levels to an excellent response. They conclude that this study confirms the effectiveness of biologics as an add-on therapy in patients with severe uncontrolled CRSwNP in the ‘real world’, with a rapid and sustained improvement seen in patients.

Responders to biologics in severe uncontrolled chronic rhinosinusitis with nasal polyps: a multicentric observational real-life study.
Mortuaire G, Bequignon E, Daveau C, et al.
RHINOLOGY
2025;63(1):22–31.