Indication for biologics in a real-world cohort of dupilumab treated chronic rhinosinusitis with nasal polyps patients according to international recommendations: evidence from the European CRS Outcome Registry (CHRINOSOR)

Abstract

Background: Criteria for biologic treatment of uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) differ across international recommendations and prescription of biologics depends on national reimbursement criteria. CHRINOSOR offers an opportunity to analyse biologic indications in the real-world setting according to international recommendations.

Methods: CRSwNP patients who received dupilumab treatment in the ENT clinic of 6 tertiary centres (5 countries) were included. Baseline demographic and lifestyle factors, NP score, SinoNasal Outcome Test-22 score, visual analogue scale for sinus symptoms, and Asthma Control Test score were retrieved from the medical records. Indication criteria for biologic treatment according to EUFOREA 2021, and EPOS/EUFOREA 2023 recommendations was applied. Dupilumab effectiveness was assessed at baseline, 24 and 52 weeks in relation to these criteria.

Results: 61.8% and 79.8% of patients met respectively the EUFOREA 2021 or the EPOS/EUFOREA 2023 indication criteria for biologic treatment. Dupilumab was effective in patients who met or did not meet international criteria for biologic indication. However, patients who met the indication criteria showed overall a more pronounced effect on most of the outcome parameters than patients who did not meet the criteria.

Conclusions: Real-world management of CRSwNP with biologics does not strictly follow the indication criteria established by international recommendations but depends on management criteria established by local authorities. These vary significantly and are either more or less stringent from one country to another. Dupilumab effectiveness in CRSwNP, whether these criteria are met or not, suggests that a broader CRSwNP population may benefit from dupilumab.