D2.476 - Mepolizumab Enables Meaningful Real-World Improvements in SNOT-22 and Smell Dysfunction in Chronic Rhinosinusitis with Nasal Polyps: Post Hoc Analysis of REALITI-N at 3 and 6 Months

Mepolizumab, a first-in-class humanised monoclonal antibody that specifically targets IL-5, has been shown to improve sinonasal symptoms and health-related quality of life (HRQoL) in patients with CRSwNP. The real-world REALITI-N study aims to assess benefits of mepolizumab in a broad population of patients with CRSwNP. 

REALITI-N is an ongoing 1-year multinational, observational cohort study, that enrolled adult patients with CRSwNP receiving mepolizumab as part of routine clinical care. Patients were identified as prospective (P, mepolizumab initiated at time of enrolment), partially retrospective (PR, mepolizumab initiated <2 months prior to enrolment) or retrospective (R, mepolizumab initiated >12 months prior to enrolment) cohorts. Mepolizumab initiation was the index date in all cohorts. This post hoc interim analysis assessed the proportion of patients achieving ≥8.9-point improvement (MCID) in SNOT-22 and change from baseline for smell dysfunction VAS at Months 3 and 6 post index. For these outcomes, only adherent patients who received ≥3 of 4 mepolizumab doses by Month 3 or ≥5 of 7 doses by Month 6 are included.

In total, 438 patients were enrolled in the P/PR cohorts (349 and 280 patients met 3- and6-month adherence criteria, respectively); 72 patients were enrolled in the R cohort (70 met adherence criteria). Mean (SD) duration of CRSwNP was 11.8 (11.3) years in the P/PR cohort and 7.0 (8.0) in the R cohort at enrolment; 63.5% and 54.2% of patients, respectively, had asthma at baseline. In the adherent patients, mean baseline SNOT-22 and smell dysfunction VAS scores are shown in Table.

At Month 3, 67.8% of patients (183/270) in the P/PR cohort and 72.7% (8/11) in R cohort achieved the MCID threshold for SNOT-22. Similarly, at Month 6, 71.3% of patients (129/181) in the P/PR cohort and 79.3% (23/29) in R cohort achieved the MCID threshold for SNOT-22. In the P/PR cohort LS mean change in smell dysfunction VAS was -1.74 at Month 3 and -2.25 at Month 6 (Table). The R cohort was too small to derive meaningful conclusions for change in smell dysfunction VAS.   

This post hoc interim analysis of REALITI-N shows that mepolizumab provides real-world benefits, as most patients demonstrated clinically meaningful improvements in patient-reported sinonasal symptoms severity and HRQoL and smell dysfunction as early as 3 and 6 months, consistent with previous clinical trial findings.

Funding: GSK (218955).