Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis
Summary
The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.
Timeline
- Start
- 2018-01-15
- Primary completion
- 2020-07-31
- Completion
- 2020-07-31
Outcome
Met primary endpoint
registry analysis (superiority test); Benra 30 mg vs Placebo; p <0.0001; Mean Difference (Net) -0.570 (95% CI -0.852 to -0.289) NCT03401229 ↗
registry analysis (superiority test); Benra 30 mg vs Placebo; p = 0.0048; Mean Difference (Net) -0.270 (95% CI -0.458 to -0.083) NCT03401229 ↗
paper Benralizumab significantly improved NPS and nasal blockage score compared to placebo at week 40 (P ≤ .005). PMID 34599979 ↗
release “OSTRO Phase III trial showed AstraZeneca’s Fasenra (benralizumab) compared with placebo demonstrated a statistically significant improvement in the size of nasal polyps” astrazeneca.com ↗
Publications
- Bachert C, Han JK, Desrosiers MY, Gevaert P, Heffler E, Hopkins C, Tversky JR, Barker P, Cohen D, Emson C, Martin UJ, Shih VH, Necander S, Kreindler JL, Jison M, Werkstrom V. Efficacy and safety of benralizumab in chronic rhinosinusitis with nasal polyps: A randomized, placebo-controlled trial. J Allergy Clin Immunol. 2022 Apr;149(4):1309-1317.e12. doi: 10.1016/j.jaci.2021.08.030. Epub 2021 Sep 29.
- Geng B, Dilley M, Anterasian C. Biologic Therapies for Allergic Rhinitis and Nasal Polyposis. Curr Allergy Asthma Rep. 2021 Jun 10;21(6):36. doi: 10.1007/s11882-021-01013-y.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benralizumab | Monoclonal antibody | 30 mg | Subcutaneous |
| Comparator | Mometasone furoate | Other / unclassified | 400 ug | Intranasal |