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Benralizumab effect on severe chronic rhinosinusitis with nasal polyps (CRSwNP): A randomized double‐blind placebo‐controlled trial
Author(s) -
Tversky Jody,
Lane Andrew P.,
Azar Antoine
Publication year - 2021
Publication title -
clinical and experimental allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.462
H-Index - 154
eISSN - 1365-2222
pISSN - 0954-7894
DOI - 10.1111/cea.13852
Subject(s) - benralizumab , medicine , placebo , nasal polyps , gastroenterology , randomized controlled trial , eosinophil , asthma , mepolizumab , pathology , alternative medicine
Summary Background Chronic rhinosinusitis with nasal polyps (CRSwNP) can be a severe and debilitating disease associated with significant morbidity, loss of smell, 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 rhinosinusitis with nasal polyps. Methods Patients with severe NP (defined by endoscopic grade 5 or more out of 8) with elevated eosinophils and a history of previous surgical or endoscopic polypectomy met entry criteria and were randomized in a double‐blind fashion to receive 30 mg 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. Results Thirty‐three patients were screened, and twenty‐four (n = 24) were enrolled in the study. Compared with baseline, benralizumab significantly improved NP score (−0.9 ± 0.2, P = 0.004) whereas placebo did not (−0.3 ± 0.3, P = 0.166). Benralizumab induced polyp size reduction compared with placebo did not reach statistical significance ( P = 0.103). Five of 12 benralizumab‐treated patients (42%) had improvements in all major outcomes (polyp score, CT, SNOT‐22 and smell test) versus 2 out of 12 placebo (17%). The ratio of blood eosinophil count to allergen skin test positivity correlated with polyp reduction. Conclusion Benralizumab was well‐tolerated and compared with baseline achieved a statistically significant reduction in nasal polyp size, sinus occupancy, symptoms and improved sensation of smell for most patients (83%).