Biologic and maintenance systemic corticosteroid therapy among US subspecialist-treated patients with severe asthma.
Adolescent
Adrenal Cortex Hormones
/ therapeutic use
Adult
Aged
Aged, 80 and over
Anti-Asthmatic Agents
/ therapeutic use
Asthma
/ drug therapy
Biological Products
/ therapeutic use
Female
Humans
Immunoglobulin E
/ metabolism
Interleukin-5
/ metabolism
Interleukin-5 Receptor alpha Subunit
/ metabolism
Male
Middle Aged
Pulmonary Disease, Chronic Obstructive
/ metabolism
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:
09 2020
09 2020
Historique:
received:
30
12
2019
revised:
01
04
2020
accepted:
06
04
2020
pubmed:
19
4
2020
medline:
26
9
2020
entrez:
19
4
2020
Statut:
ppublish
Résumé
Severe asthma (SA) often requires subspecialist management and treatment with biologic therapies or maintenance systemic corticosteroids (mSCS). To describe contemporary, real-world biologic and mSCS use among US subspecialist-treated patients with SA. CHRONICLE is an ongoing, noninterventional study of US adults with SA treated by allergists/immunologists or pulmonologists. Eligible patients are receiving biologics or mSCS or are uncontrolled on high-dosage inhaled corticosteroids with additional controllers. Biologic and mSCS use patterns and patient characteristics were summarized for patients enrolled between February 2018 and February 2019. Among protocol-eligible patients, 58% and 12% were receiving biologics and mSCS, respectively, with 7% receiving both. Among 796 enrolled, most were women (67%), non-Hispanic white (71%), of suburban residence (50%), and had elevated body mass index (median: 31). Respiratory and nonrespiratory comorbidities were highly prevalent. With biologics (n = 557), 51% were anti-immunoglobulin E and 48% were anti-interleukin (IL)-5/IL-5Rα; from May 2018, 76% of initiations were anti-IL-5/IL-5Rα. In patients receiving mSCS, median prednisone-equivalent daily dose was 10 mg. Multivariate logistic regression found that patients of hospital clinics, sites with fewer nonphysician staff, and with a recorded concurrent chronic obstructive pulmonary disease diagnosis were less likely to receive biologics and more likely to receive mSCS. In this real-world sample of US subspecialist-treated patients with SA not controlled by high-dosage inhaled corticosteroids with additional controllers, mSCS use was infrequent and biologic use was common, with similar prevalence of anti-immunoglobulin E and anti-IL-5/IL-5Rα biologics. Treatment differences associated with patient and site characteristics should be investigated to ensure equitable access to biologics and minimize mSCS use. ClinicalTrials.gov Identifier: NCT03373045.
Sections du résumé
BACKGROUND
Severe asthma (SA) often requires subspecialist management and treatment with biologic therapies or maintenance systemic corticosteroids (mSCS).
OBJECTIVE
To describe contemporary, real-world biologic and mSCS use among US subspecialist-treated patients with SA.
METHODS
CHRONICLE is an ongoing, noninterventional study of US adults with SA treated by allergists/immunologists or pulmonologists. Eligible patients are receiving biologics or mSCS or are uncontrolled on high-dosage inhaled corticosteroids with additional controllers. Biologic and mSCS use patterns and patient characteristics were summarized for patients enrolled between February 2018 and February 2019.
RESULTS
Among protocol-eligible patients, 58% and 12% were receiving biologics and mSCS, respectively, with 7% receiving both. Among 796 enrolled, most were women (67%), non-Hispanic white (71%), of suburban residence (50%), and had elevated body mass index (median: 31). Respiratory and nonrespiratory comorbidities were highly prevalent. With biologics (n = 557), 51% were anti-immunoglobulin E and 48% were anti-interleukin (IL)-5/IL-5Rα; from May 2018, 76% of initiations were anti-IL-5/IL-5Rα. In patients receiving mSCS, median prednisone-equivalent daily dose was 10 mg. Multivariate logistic regression found that patients of hospital clinics, sites with fewer nonphysician staff, and with a recorded concurrent chronic obstructive pulmonary disease diagnosis were less likely to receive biologics and more likely to receive mSCS.
CONCLUSION
In this real-world sample of US subspecialist-treated patients with SA not controlled by high-dosage inhaled corticosteroids with additional controllers, mSCS use was infrequent and biologic use was common, with similar prevalence of anti-immunoglobulin E and anti-IL-5/IL-5Rα biologics. Treatment differences associated with patient and site characteristics should be investigated to ensure equitable access to biologics and minimize mSCS use.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03373045.
Identifiants
pubmed: 32304877
pii: S1081-1206(20)30232-5
doi: 10.1016/j.anai.2020.04.004
pii:
doi:
Substances chimiques
Adrenal Cortex Hormones
0
Anti-Asthmatic Agents
0
Biological Products
0
Interleukin-5
0
Interleukin-5 Receptor alpha Subunit
0
Immunoglobulin E
37341-29-0
Banques de données
ClinicalTrials.gov
['NCT03373045']
Types de publication
Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
294-303.e1Informations de copyright
Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.