TY - JOUR
T1 - Burden of Uncontrolled Severe Asthma With and Without Elevated Type-2 Inflammatory Biomarkers
AU - NOVELTY Scientific Community
AU - NOVELTY study Investigators
AU - Ding, Bo
AU - Chen, Stephanie
AU - Rapsomaniki, Eleni
AU - Quinton, Anna
AU - Cook, William
AU - Reddel, Helen K.
AU - Papi, Alberto
AU - del Olmo, Ricardo
AU - Anderson, Gary
AU - Reddel, Helen
AU - Rabahi, Marcelo
AU - McIvor, Andrew
AU - Sadatsafavi, Mohsen
AU - Weinreich, Ulla
AU - Burgel, Pierre Régis
AU - Devouassoux, Gilles
AU - Inoue, Hiromasa
AU - Rendon, Adrián
AU - van den Berge, Maarten
AU - Beasley, Richard
AU - García-Navarro, Alvar Agusti
AU - Faner, Rosa
AU - Rivera, José Olaguibel
AU - Janson, Christer
AU - Bilińska-Izydorczyk, Magdalena
AU - Fagerås, Malin
AU - Fihn-Wikander, Titti
AU - Franzén, Stefan
AU - Keen, Christina
AU - Ostridge, Kristoffer
AU - Chalmers, James
AU - Harrison, Timothy
AU - Pavord, Ian
AU - Price, David
AU - Azim, Adnan
AU - Belton, Laura
AU - Blé, Francois Xavier
AU - Erhard, Clement
AU - Gairy, Kerry
AU - Hughes, Rod
AU - Lassi, Glenda
AU - Müllerová, Hana
AU - Scott, Ian Christopher
AU - Chipps, Bradley
AU - Christenson, Stephanie
AU - Make, Barry
AU - Tomaszewski, Erin
AU - Benhabib, Gabriel
AU - Ruiz, Xavier Bocca
AU - Inomata, Minehiko
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024/4
Y1 - 2024/4
N2 - Background: Many patients with asthma have type-2 airway inflammation, identified by the presence of biomarkers, including history of allergy, high blood eosinophil (EOS) count, and high fractional exhaled nitric oxide levels. Objective: To assess disease burden in relation to type-2 inflammatory biomarker status (history of allergy, blood EOS count, and fractional exhaled nitric oxide level) in patients with uncontrolled and controlled severe asthma in the NOVEL observational longiTudinal studY (NOVELTY) (NCT02760329). Methods: Asthma diagnosis and severity were physician-reported. Control was defined using Asthma Control Test score (uncontrolled <20, controlled ≥20) and/or 1 or more severe physician-reported exacerbation in the previous year. Biomarker distribution (history of allergy, blood EOS count, and fractional exhaled nitric oxide level), symptom burden (Asthma Control Test score, modified Medical Research Council dyspnea scale), health status (St George's Respiratory Questionnaire score), exacerbations, and health care resource utilization were assessed. Results: Of 647 patients with severe asthma, 446 had uncontrolled and 123 had controlled asthma. Among those with uncontrolled asthma, 196 (44%) had 2 or more positive biomarkers, 187 (42%) had 1 positive biomarker, 325 (73%) had low blood EOS, and 63 (14%) were triple-negative. Disease burden was similarly high across uncontrolled subgroups, irrespective of biomarker status, with poor symptom control (Asthma Control Test score 14.9-16.6), impaired health status (St George's Respiratory Questionnaire total score 46.7-49.4), clinically important breathlessness (modified Medical Research Council grade ≥2 in 47.3%-57.1%), and 1 or more severe exacerbation (70.6%-76.2%). Conclusions: Type-2 inflammatory biomarkers did not differentiate disease burden in patients with severe asthma. Patients with low type-2 inflammatory biomarker levels have few biologic therapy options; their needs should be addressed.
AB - Background: Many patients with asthma have type-2 airway inflammation, identified by the presence of biomarkers, including history of allergy, high blood eosinophil (EOS) count, and high fractional exhaled nitric oxide levels. Objective: To assess disease burden in relation to type-2 inflammatory biomarker status (history of allergy, blood EOS count, and fractional exhaled nitric oxide level) in patients with uncontrolled and controlled severe asthma in the NOVEL observational longiTudinal studY (NOVELTY) (NCT02760329). Methods: Asthma diagnosis and severity were physician-reported. Control was defined using Asthma Control Test score (uncontrolled <20, controlled ≥20) and/or 1 or more severe physician-reported exacerbation in the previous year. Biomarker distribution (history of allergy, blood EOS count, and fractional exhaled nitric oxide level), symptom burden (Asthma Control Test score, modified Medical Research Council dyspnea scale), health status (St George's Respiratory Questionnaire score), exacerbations, and health care resource utilization were assessed. Results: Of 647 patients with severe asthma, 446 had uncontrolled and 123 had controlled asthma. Among those with uncontrolled asthma, 196 (44%) had 2 or more positive biomarkers, 187 (42%) had 1 positive biomarker, 325 (73%) had low blood EOS, and 63 (14%) were triple-negative. Disease burden was similarly high across uncontrolled subgroups, irrespective of biomarker status, with poor symptom control (Asthma Control Test score 14.9-16.6), impaired health status (St George's Respiratory Questionnaire total score 46.7-49.4), clinically important breathlessness (modified Medical Research Council grade ≥2 in 47.3%-57.1%), and 1 or more severe exacerbation (70.6%-76.2%). Conclusions: Type-2 inflammatory biomarkers did not differentiate disease burden in patients with severe asthma. Patients with low type-2 inflammatory biomarker levels have few biologic therapy options; their needs should be addressed.
KW - Allergy
KW - Asthma
KW - Disease burden
KW - Eosinophil
KW - Exacerbations
KW - Fractional exhaled nitric oxide
KW - Health care resource utilization
KW - Health status
KW - Symptom control
KW - Type-2 inflammatory biomarkers
UR - http://www.scopus.com/inward/record.url?scp=85183143726&partnerID=8YFLogxK
U2 - 10.1016/j.jaip.2023.12.021
DO - 10.1016/j.jaip.2023.12.021
M3 - 学術論文
C2 - 38141721
AN - SCOPUS:85183143726
SN - 2213-2198
VL - 12
SP - 970
EP - 982
JO - Journal of Allergy and Clinical Immunology: In Practice
JF - Journal of Allergy and Clinical Immunology: In Practice
IS - 4
ER -