Severe asthma exacerbations in the United States:: Incidence, characteristics, predictors, and effects of biologic treatments.
Adolescent
Adrenal Cortex Hormones
/ therapeutic use
Adult
Aged
Aged, 80 and over
Anti-Asthmatic Agents
/ therapeutic use
Asthma
/ drug therapy
Biological Products
/ therapeutic use
Eosinophilia
/ pathology
Eosinophils
/ cytology
Female
Hospitalization
/ statistics & numerical data
Humans
Immunoglobulin E
/ blood
Male
Middle Aged
Nitric Oxide
/ analysis
Severity of Illness Index
Symptom Flare Up
United States
Young Adult
Journal
Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology
ISSN: 1534-4436
Titre abrégé: Ann Allergy Asthma Immunol
Pays: United States
ID NLM: 9503580
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
received:
02
03
2021
revised:
06
07
2021
accepted:
12
07
2021
pubmed:
18
7
2021
medline:
11
11
2021
entrez:
17
7
2021
Statut:
ppublish
Résumé
Patients with severe asthma (SA) have a heightened risk of exacerbations including hospitalization. The real-world, specialist-verified incidence and characteristics of exacerbations among patients with SA in the United States have not been described. To describe the real-world incidence, characteristics, and predictors of exacerbations among patients with SA in the United States. The CHRONICLE study is an ongoing observational study of specialist-treated adults with SA in the United States receiving biologic treatment or maintenance systemic corticosteroids or uncontrolled by high-dosage inhaled corticosteroids with additional controllers. For patients enrolled from February 2018 to February 2020, annualized rates and characteristics of exacerbation-related events were summarized by treatment category for 12 months before enrollment and after enrollment through the latest data collection. Results were further analyzed for subgroups of interest. Among 1884 enrolled patients, 53.5% and 12.3% experienced an exacerbation and asthma hospitalization, respectively (0.81 and 0.14 per person-year). Of all exacerbations, 36%, 9%, and 15% required an unscheduled health care provider visit, emergency department visit without hospitalization, and hospitalization, respectively. Among patients not receiving biologics or systemic corticosteroids, higher blood eosinophil count, higher fractional exhaled nitric oxide, and lower total immunoglobulin E level were associated with higher exacerbation rates. Exacerbation rates decreased after starting or switching biologics (n = 1299). Multivariate analyses of enrolled patients revealed previous-year exacerbations or hospitalizations, lack of asthma control, and the geographic region also predicted event risk. In this real-world cohort of specialist-treated adults with SA in the United States, there was a substantial burden of exacerbations and associated health care resource utilization. Patients receiving biologics had a lower exacerbation burden. ClinicalTrials.gov Identifier: NCT03373045.
Sections du résumé
BACKGROUND
Patients with severe asthma (SA) have a heightened risk of exacerbations including hospitalization. The real-world, specialist-verified incidence and characteristics of exacerbations among patients with SA in the United States have not been described.
OBJECTIVE
To describe the real-world incidence, characteristics, and predictors of exacerbations among patients with SA in the United States.
METHODS
The CHRONICLE study is an ongoing observational study of specialist-treated adults with SA in the United States receiving biologic treatment or maintenance systemic corticosteroids or uncontrolled by high-dosage inhaled corticosteroids with additional controllers. For patients enrolled from February 2018 to February 2020, annualized rates and characteristics of exacerbation-related events were summarized by treatment category for 12 months before enrollment and after enrollment through the latest data collection. Results were further analyzed for subgroups of interest.
RESULTS
Among 1884 enrolled patients, 53.5% and 12.3% experienced an exacerbation and asthma hospitalization, respectively (0.81 and 0.14 per person-year). Of all exacerbations, 36%, 9%, and 15% required an unscheduled health care provider visit, emergency department visit without hospitalization, and hospitalization, respectively. Among patients not receiving biologics or systemic corticosteroids, higher blood eosinophil count, higher fractional exhaled nitric oxide, and lower total immunoglobulin E level were associated with higher exacerbation rates. Exacerbation rates decreased after starting or switching biologics (n = 1299). Multivariate analyses of enrolled patients revealed previous-year exacerbations or hospitalizations, lack of asthma control, and the geographic region also predicted event risk.
CONCLUSION
In this real-world cohort of specialist-treated adults with SA in the United States, there was a substantial burden of exacerbations and associated health care resource utilization. Patients receiving biologics had a lower exacerbation burden.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03373045.
Identifiants
pubmed: 34273485
pii: S1081-1206(21)00501-9
doi: 10.1016/j.anai.2021.07.010
pii:
doi:
Substances chimiques
Adrenal Cortex Hormones
0
Anti-Asthmatic Agents
0
Biological Products
0
Nitric Oxide
31C4KY9ESH
Immunoglobulin E
37341-29-0
Banques de données
ClinicalTrials.gov
['NCT03373045']
Types de publication
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
579-587.e1Informations de copyright
Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.