Mepolizumab reduces the need for surgery in patients with chronic rhinosinusitis with nasal polyps

Wytske J. Fokkens, Joaquim Mullol, David W. Kennedy, Carl Philpott, Veronica Seccia, Robert Kern, Andre Coste, Ana Sousa, Peter Howarth, Victoria Benson, Bhabita Mayer, Steve Yancey, Robert Chan, Simon Gane

Research output: Contribution to conferencePoster

Abstract

Background: For patients with chronic rhinosinusitis with nasal polyps (CRSwNP), endoscopic sinus surgery (ESS) can be associated with high recurrence rates despite intranasal corticosteroids (as part of standard of care [SoC]). We assessed the impact of mepolizumab, a humanized anti-interleukin-5 antibody, on the need for repeat ESS in patients with CRSwNP. Methods: SYNAPSE, a randomized, double-blind, placebo-controlled, multicenter study, enrolled patients with CRSwNP uncontrolled with SoC. All patients had ≥1 ESS in the past 10 years and were eligible for repeat ESS. Patients received 4-weekly subcutaneous (SC) mepolizumab 100 mg or placebo, plus SoC, for 52 Weeks. We assessed the proportion of patients with a need for ESS (visual analog scale overall symptom score >7; endoscopic bilateral NP score ≥5), time to inclusion on a waiting list for ESS (Kaplan–Meier [KM] estimate), and the proportion of patients included on a waiting list, by Week 52. Results: Data from 407 patients (placebo n=201; mepolizumab n=206) were analyzed. Mean (SD) duration of CRSwNP was 11.4 (8.4) years; 218 (54%) patients had ≥2 ESS in the past 10 years. After 52 weeks, more patients using mepolizumab vs placebo were identified as not needing ESS (72% vs 51%, respectively; odds ratio [95% confidence interval] 2.46 [1.59, 3.79]; P<0.001). KM estimates indicated a ~50% lower risk of inclusion on a waiting list for ESS with mepolizumab than placebo. Up to Week 52, 16% vs 30% of patients using mepolizumab vs placebo were due for ESS on a waiting list. Conclusions: Mepolizumab 100 mg SC reduces the need for repeat surgery compared with placebo for patients with recurrent CRSwNP despite SoC therapy.
Original languageEnglish
Publication statusPublished - 2021

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