Benralizumab effect on severe chronic rhinosinusitis with nasal polyps (CRSwNP): A randomized double‐blind placebo‐controlled trial. Issue 6 (27th February 2021)

• Record Type: Journal Article
• Authors: Tversky, Jody; Lane, Andrew P.; Azar, Antoine
• Is Part Of: Clinical & experimental allergy. Volume 51:Issue 6(2021)
• Page Start: 836
• Page End: 844
• Publication Date: 2021-02-27
• Subjects: benralizumab -- chronic rhinosinusitis -- eosinophils -- nasal polyps -- skin test -- smell test; Allergy -- Periodicals; Immunology -- Periodicals; 616.97
• DOI: 10.1111/cea.13852
• Languages: English
• ISSNs: 0954-7894

Abstract

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%).