A pilot prospective longitudinal study comparing dupilumab to surgery in CRSwNP

Background: To date, there have not been any direct comparative studies assessing clinical outcomes in CRSwNP between biologic and surgical therapies. Objective: To directly compare the effect of dupilumab to FESS using subjective and objective outcomes of CRSwNP patients in a prospective longitudinal study. Methods: We prospectively enrolled 20 CRSwNP patients and counseled them on both biologic and surgical options. Patients were able to decide on either therapy, and data collected at baseline and 3-, 6-, 9-, and 12-months with subjective outcomes including the nasal congestion score (NCS) and SNOT-22 questionnaires, and objectively by degree of smell (UPSIT-40) and nasal polyp score (NPS). Results: All subjects met criteria for either biologic therapy or surgery, with NPS >5, Lund-Mackay score (LMK-CT)>16, SNOT-22>54, and were graded as anosmic/hyposmic. There were no significant differences in age, sex, comorbid asthma/Aspirin Exacerbated Respiratory Disease, or prior FESS between groups. Both dupilumab and FESS significantly improved outcomes by one year in patients with severe CRSwNP when compared to baseline. At one-year, patients on dupilumab had greater improvement in NCS, UPSIT and asthma control relative to one year post FESS. In a subgroup of patients with a history of prior sinus surgery and asthma, dupilumab had lower polyp recurrence rate compared to one year post FESS. Conclusions: Both dupilumab and FESS can significantly improve outcomes by one year in CRSwNP patients. However, in those with a history of asthma and prior surgery, dupilumab is more effective in reducing polyp recurrence and improving sinonasal outcomes than FESS.