Dupilumab Monthly Dose De-Escalation Maintains Efficacy in CRSwNP: A Two-Year Real-World Study

Objective: The aim of this study was to evaluate if dupilumab interval dose de-escalation to every 4 weeks negatively impacts treatment outcomes in real-life practice for severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) during the first 2 years of treatment. Methods: We enrolled 148 patients who completed 2 years of follow-up. We compared two homogenous groups in terms of severity: group A included 77 patients who never modified the interval of administration during follow-up; group B included 71 patients who extended the dosing interval to monthly administration. We compared the treatment outcomes and differences in safety. Results: The monthly interval dose prolongation was started in 22/71 patients (30.99%) at 6 months, in 11/71 (15.48%) at 9 months, in 22/71 (30.99%) at 12 months, and in 16/71 (22.54%) at 18 months. The dose prolongation was to manage minor adverse events in 9 of 71 patients; persistent eosinophilia in 26/71 patients; specific request of patients who had confirmed sustained control as determined by the physician's assessment in 36/71 cases. Mean values of all outcomes of response to treatment (i.e., volume of polyps, nasal obstruction, quality of life, olfaction) significantly improved at 6, 12, and 24 months compared to baseline (p < 0.01) in both groups A and B. No significant differences were found comparing groups A and B for any of the outcomes examined over the 2 years of follow-up (p < 0.01). Conclusion: These results suggest that extending to monthly dosing of dupilumab in real life does not negatively impact outcomes in patients with severe uncontrolled CRSwNP. Level of Evidence: 3.