Efficacy of Tezepelumab in Patients with Severe, Uncontrolled Asthma and Perennial Allergy.
Allergens
Asthma
Eosinophil
IgE
Omalizumab
Tezepelumab
Thymic stromal lymphopoietin
Journal
The journal of allergy and clinical immunology. In practice
ISSN: 2213-2201
Titre abrégé: J Allergy Clin Immunol Pract
Pays: United States
ID NLM: 101597220
Informations de publication
Date de publication:
12 2021
12 2021
Historique:
received:
10
02
2021
revised:
27
06
2021
accepted:
18
07
2021
pubmed:
7
8
2021
medline:
29
12
2021
entrez:
6
8
2021
Statut:
ppublish
Résumé
Tezepelumab is an anti-thymic stromal lymphopoietin mAb. In the PATHWAY phase IIb study (NCT02054130), tezepelumab significantly reduced annualized asthma exacerbation rates (AAERs) versus placebo in adults with severe, uncontrolled asthma. This post hoc analysis assessed the efficacy of tezepelumab in PATHWAY participants with perennial allergy. Adults (N = 550) with severe, uncontrolled asthma were randomized to receive tezepelumab (70 mg or 210 mg every 4 weeks or 280 mg every 2 weeks) or placebo, for 52 weeks. The AAER over 52 weeks was analyzed in patients grouped by sensitivity to perennial aeroallergens and by eligibility for omalizumab treatment according to the US or European Union prescribing information. Change from baseline to week 52 in prebronchodilator FEV Across doses, tezepelumab reduced the AAER versus placebo by 66% to 78% in patients with perennial allergy (n = 254) and 67% to 71% in patients without perennial allergy (n = 261). Tezepelumab improved prebronchodilator FEV Treatment with tezepelumab reduced exacerbations, improved lung function, and reduced type 2 biomarkers versus placebo in patients with severe, uncontrolled asthma with or without perennial allergy, further supporting its efficacy in a broad population of patients with severe, uncontrolled asthma.
Sections du résumé
BACKGROUND
Tezepelumab is an anti-thymic stromal lymphopoietin mAb. In the PATHWAY phase IIb study (NCT02054130), tezepelumab significantly reduced annualized asthma exacerbation rates (AAERs) versus placebo in adults with severe, uncontrolled asthma.
OBJECTIVE
This post hoc analysis assessed the efficacy of tezepelumab in PATHWAY participants with perennial allergy.
METHODS
Adults (N = 550) with severe, uncontrolled asthma were randomized to receive tezepelumab (70 mg or 210 mg every 4 weeks or 280 mg every 2 weeks) or placebo, for 52 weeks. The AAER over 52 weeks was analyzed in patients grouped by sensitivity to perennial aeroallergens and by eligibility for omalizumab treatment according to the US or European Union prescribing information. Change from baseline to week 52 in prebronchodilator FEV
RESULTS
Across doses, tezepelumab reduced the AAER versus placebo by 66% to 78% in patients with perennial allergy (n = 254) and 67% to 71% in patients without perennial allergy (n = 261). Tezepelumab improved prebronchodilator FEV
CONCLUSIONS
Treatment with tezepelumab reduced exacerbations, improved lung function, and reduced type 2 biomarkers versus placebo in patients with severe, uncontrolled asthma with or without perennial allergy, further supporting its efficacy in a broad population of patients with severe, uncontrolled asthma.
Identifiants
pubmed: 34358701
pii: S2213-2198(21)00886-2
doi: 10.1016/j.jaip.2021.07.045
pii:
doi:
Substances chimiques
Anti-Asthmatic Agents
0
Antibodies, Monoclonal, Humanized
0
tezepelumab
RJ1IW3B4QX
Banques de données
ClinicalTrials.gov
['NCT03989544', 'NCT02054130']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
4334-4342.e6Informations de copyright
Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.