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Randomized Controlled Trial
. 2021 Jun;51(6):836-844.
doi: 10.1111/cea.13852. Epub 2021 Feb 27.

Benralizumab effect on severe chronic rhinosinusitis with nasal polyps (CRSwNP): A randomized double-blind placebo-controlled trial

Jody Tversky  1 , Andrew P Lane  2 , Antoine Azar  1
Affiliations
Randomized Controlled Trial

Benralizumab effect on severe chronic rhinosinusitis with nasal polyps (CRSwNP): A randomized double-blind placebo-controlled trial

Jody Tversky et al. Clin Exp Allergy. 2021 Jun.

Abstract

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%).

Trial registration: ClinicalTrials.gov NCT03450083.

Keywords: benralizumab; chronic rhinosinusitis; eosinophils; nasal polyps; skin test; smell test.

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References

REFERENCES

    1. Hastan D, Fokkens WJ, Bachert C, et al. Chronic rhinosinusitis in Europe--an underestimated disease. A GA(2)LEN study. Allergy. 66(9):1216-1223.
    1. Jarvis D, Newson R, Lotvall J, et al. Asthma in adults and its association with chronic rhinosinusitis: the GA2LEN survey in Europe. Allergy. 67(1):91-98.
    1. Mucci T, Govindaraj S, Tversky J. Allergic rhinitis. Mt Sinai J Med. 2011;78(5):634-644.
    1. Tversky JR, Bieneman AP, Chichester KL, Hamilton RG, Schroeder JT. Subcutaneous allergen immunotherapy restores human dendritic cell innate immune function. Clin Exp Allerg. 2010;40(1):94-102.
    1. Gevaert P, Calus L, Van Zele T, et al. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol. 131(1):110-116 e1.

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