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

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. 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. 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. 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.

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© 2024 Le et al.

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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.