Benralizumab Effect on Severe Nasal Polyps: A Randomized Placebo
Controlled Trial
Abstract
Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) can be a
severe and debilitating disease associated with significant morbidity,
complete anosmia, sinus pressure, and asthma exacerbations. Eosinophils
play a role in the majority (85%) of patients. Benralizumab, an
afucosylated monoclonal antibody directed against the IL-5 receptor has
powerful apoptotic effects on eosinophils. Objective: We sought to
investigate the therapeutic benefit of inhibiting the IL-5 receptor
using benralizumab to treat severe nasal polyposis. Methods: Twenty-four
patients (n = 24) with severe NP (grade 5 or more out of 8) with
elevated eosinophils and a history of previous polypectomy were
randomized in a double-blind fashion to receive 30mg benralizumab SC or
placebo. Endoscopic NP score was assessed at baseline and at treatment
week 20. CT scan, SNOT-22 survey, and UPSIT smell test score changes
were also evaluated from baseline. Results: Compared to baseline, 8 out
12 patients receiving benralizumab had a significantly improved NP score
versus 4 out of 12 placebo. 5 of 12 benralizumab treated patients had
improvements in all major outcomes (polyp score, CT, SNOT-22 and smell
test) versus 2 out of 12 placebo. The ratio of blood eosinophil count to
allergen skin test positivity correlated with polyp reduction.
Conclusion: Compared to baseline, benralizumab achieved a statistically
significant reduction in polyp size by endoscopy and CT scan and was
associated with both less symptoms and improved sensation of smell for
most patients (10 of 12).