Benralizumab in Severe Eosinophilic Asthma and Chronic Rhinosinusitis with Nasal Polyps: The Real-World, Multi-Country RANS Observational Study

Abstract

Purpose

Real-world evidence of benralizumab effectiveness on nasal polyps (NP) and asthma outcomes in patients with severe eosinophilic asthma (SEA) and comorbid chronic rhinosinusitis with NP are limited. The objective of this study was to assess NP and asthma outcomes in benralizumab-treated patients with SEA and comorbid NP in a real-world setting.

Patients and Methods

RANS was a retrospective, multi-country observational study (ClinicalTrials.gov: NCT05180357) using medical chart reviews of adults with SEA and comorbid NP. Total NP Score (NPS), SinoNasal Outcome Test-22 (SNOT-22) total score, annualized exacerbation rate (AER), and 6-item Asthma Control Questionnaire (ACQ-6) and Asthma Control Test (ACT) scores during the 12 months pre-index (baseline) and post-index (follow-up) were measured. Clinically meaningful improvement from baseline following treatment, in terms of total NPS (≥1-point reduction), SNOT-22 total (≥8.9-point reduction), ACQ-6 (≥0.5-point reduction) or ACT (≥3-point increase) scores, were reported.

Results

A total of 233 patients were included. Baseline mean (standard deviation [SD]) NPS and SNOT-22 total scores were 3.8 (2.4) and 47.5 (22.6), respectively. The mean change (95% confidence interval [CI]) from baseline was –1.2 (–1.7, –0.6) for NPS, and –19.8 (–23.6, –15.9) for SNOT-22. The AER (95% CI) was 1.2 (0.96, 1.41) at baseline and 0.2 (0.13, 0.28) at follow-up. Mean (SD) ACQ-6 and ACT scores were 1.6 (1.3) and 15.0 (5.2) at baseline and 0.8 (1.0) and 22.0 (3.9) at follow-up, respectively. The proportion of patients who achieved clinically meaningful improvements in NPS, SNOT-22 total, ACQ-6, and ACT scores was 49.1%, 67.6%, 56.6%, and 81.1%, respectively.

Conclusion

In this real-world study, improvements in NP and asthma outcomes in patients with SEA and comorbid NP were observed during the 12 months following benralizumab initiation.

Keywords:

• exacerbations
• comorbidity
• biologics
• patient-reported outcomes
• SinoNasal Outcome Test-22
• Nasal Polyps Score

Abbreviations

ACT, Asthma Control Test; ACQ-6, 6-item Asthma Control Questionnaire; AER, annualized exacerbation rate; CI, confidence interval; EUFOREA, European Forum for Research and Education in Allergy and Airway Diseases; FeNO, fractional exhaled nitric acid; HRQoL, health-related quality of life; NP, nasal polyps; NPS, Nasal Polyp Score; OCS, oral corticosteroid; SCS, systemic corticosteroid; SD, standard deviation; SEA, severe eosinophilic asthma; SNOT-22, SinoNasal Outcome Test-22.

Data Sharing Statement

Data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca’s data sharing policy described at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Acknowledgments

We would like to thank all patients for their participation, and the RANS study principal investigators and other staff at the study sites (Supplementary Table 1); Dr James Kreindler as previous Senior Global Medical Affair Lead for the RANS study; and Joseph Gaab for support with programming and analysis.

This study was supported by AstraZeneca. The authors would like to thank Susanne Ulm and Anna Mett of inScience Communications, Springer Healthcare Ltd, UK, for providing medical writing support, in accordance with Good Publication Practice guidelines, which was funded by AstraZeneca.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas. All authors have drafted or substantially revised or critically reviewed the article. All authors have agreed on the journal to which the article will be submitted. All authors reviewed and agreed on all versions of the article before submission, during revision, the final version accepted for publication, and any significant changes introduced at the proofing stage. All authors agree to take responsibility and be accountable for the contents of the article.

Disclosure

Tham T. Le, Benjamin Emmanuel, David S. Cohen, Trung N. Tran, Yunhui Cao and Vivian H. Shih are employees of, and own stock in, AstraZeneca. Rohit Katial and Justin J. Kwiatek are former employees of AstraZeneca, Denver, CO, USA, and Justin J. Kwiatek is an employee of GlaxoSmithKline, Upper Providence, PA, USA since June 2023. Shoshana Daniel is an employee of Fortrea Inc. Maria Gil Melcón reports consultancy fees from AstraZeneca, GlaxoSmithKline, Novartis, and Sanofi Genzyme, and participation at medical meetings for AstraZeneca, GlaxoSmithKline, Novartis, and Sanofi Genzyme. Gilles Devouassoux reports consultancy fees from ALK, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Menarini, Mundipharma, Novartis Pharma, Sanofi, and Vivisol; participation at medical meetings for AGIR à dom, ALK, AstraZeneca, Boehringer Ingelheim, Chiesi, CIPLA, GlaxoSmithKline, Meda, MSD, Menarini, Novartis Pharma, Orkyn, Sanofi, Takeda, and TEVA; PI for clinical trials from AB Science, ALK, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Gossamer, Lilly, Novartis Pharma, Regeneron, Roche, Sanofi, Teva, Vitalair, and Zambon; and research grants from AGIR à dom, ALLP, Chiesi, GlaxoSmithKline, MSD, Novartis Pharma, Orkyn, Takeda, and Vivisol. Girolamo Pelaia reports advisory board fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Guidotti, Insmed, Lusofarmaco, Menarini, Neopharmed Gentili, Novartis, Sanofi, and Zambon. The authors report no other conflicts of interest in this work.