Two-Year Turning Point With Dupilumab in CRSwNP: Control, Remission, and Tapering Dosage.

Abstract

Background: Dupilumab is an effective treatment for severe, uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP). Most real-life studies have been conducted on small patient cohorts for up to 1 year.

Methods: This ambispective, multicentric, 2-year-long study evaluated dupilumab effectiveness (including treatment response, disease control, and remission) and safety in severe, uncontrolled CRSwNP patients from the DUPIREAL Italian study centers.

Results: The study involved 926 patients. At 24 months, median nasal polyp score (NPS), nasal obstruction visual analogue scale (VAS), Sino-nasal Outcome Test-22 (SNOT-22), and olfaction improved from baseline (all p < 0.0001). Patients with NPS > 4, and/or SNOT-22 > 30, and/or Sniffin' Sticks Identification Test-16 (SSIT-16) < 12 at 12 months demonstrated improvements in these outcomes over the second year. Overall, 18.7% of patients extended the dupilumab interdose interval to every 4 weeks (q4w). Notably, 91.2% of patients were "good-to-excellent" responders based on EPOS/Euforea criteria. Given the absence of standardized definitions for disease control and remission, we proposed different sets of criteria reporting results from different scenarios. Remission analysis is clinically important as it helps define treatment success and long-term therapeutic goals. Most adverse events were mild-to-moderate; 2.4% of patients discontinued treatment due to safety concerns.

Conclusions: This is the largest real-life study evaluating dupilumab in CRSwNP over 2 years. Dupilumab showed sustained effectiveness, with progressive improvements across all clinical outcomes. Dupilumab tapering did not compromise outcomes; treatment continuation allowed meaningful clinical benefits in late responders. Two-year rates of disease control and remission are clinically relevant, although standardized criteria to assess these outcomes are needed.