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Benralizumab in Severe Eosinophilic Asthma and Chronic Rhinosinusitis with Nasal Polyps: The Real-World, Multi-Country RANS Observational Study.
Le, Tham T; Emmanuel, Benjamin; Katial, Rohit; Tran, Trung N; Kwiatek, Justin Joseph; Cohen, David S; Daniel, Shoshana R; Cao, Yunhui; Shih, Vivian H; Melcón, Maria Gil; Devouassoux, Gilles; Pelaia, Girolamo.
Afiliación
  • Le TT; BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.
  • Emmanuel B; BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.
  • Katial R; Center for Clinical Immunology, National Jewish Health & University of Colorado School of Medicine, Denver, CO, USA.
  • Tran TN; BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.
  • Kwiatek JJ; BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.
  • Cohen DS; BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.
  • Daniel SR; Market Access Consulting, Fortrea Inc., Durham, NC, USA.
  • Cao Y; BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.
  • Shih VH; BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.
  • Melcón MG; Otorhinolaryngology and Head and Neck Surgery Department, University Hospital of Salamanca, Salamanca, Spain.
  • Devouassoux G; Department of Pulmonology, Hospices Civils de Lyon (HCL), Hôpital de la Croix-Rousse, Lyon, and F-CRIN INSERM Network CRISALIS, Toulouse, France.
  • Pelaia G; Department of Health Sciences, University "Magna Graecia" of Catanzaro, Catanzaro, Italy.
J Asthma Allergy ; 17: 313-324, 2024.
Article en En | MEDLINE | ID: mdl-38595692
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.
Palabras clave

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Asthma Allergy Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Nueva Zelanda

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Asthma Allergy Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Nueva Zelanda