Burden of Uncontrolled Severe Asthma With and Without Elevated Type-2 Inflammatory Biomarkers

Bo Ding; Stephanie Chen; Eleni Rapsomaniki; Anna Quinton; William Cook; Helen K. Reddel; Alberto Papi; NOVELTY Scientific Community; NOVELTY Study Investigators; Kerry Hancock

doi:10.1016/j.jaip.2023.12.021

Burden of Uncontrolled Severe Asthma With and Without Elevated Type-2 Inflammatory Biomarkers

Bo Ding, Stephanie Chen, Eleni Rapsomaniki, Anna Quinton, William Cook, Helen K. Reddel, Alberto Papi, NOVELTY Scientific Community, NOVELTY Study Investigators, Kerry Hancock

College of Medicine and Public Health

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

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Abstract

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.

Original language	English
Pages (from-to)	970-982
Number of pages	13
Journal	Journal of Allergy and Clinical Immunology: In Practice
Volume	12
Issue number	4
DOIs	https://doi.org/10.1016/j.jaip.2023.12.021
Publication status	Published - Apr 2024

Keywords

Allergy
Asthma
Disease burden
Eosinophil
Exacerbations
Fractional exhaled nitric oxide
Health care resource utilization
Health status
Symptom control
Type-2 inflammatory biomarkers

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.jaip.2023.12.021Licence: CC BY

Final published versionFinal published version, 604 KBLicence: CC BY

Cite this

Ding, B., Chen, S., Rapsomaniki, E., Quinton, A., Cook, W., Reddel, H. K., Papi, A., NOVELTY Scientific Community, NOVELTY Study Investigators, & Hancock, K. (2024). Burden of Uncontrolled Severe Asthma With and Without Elevated Type-2 Inflammatory Biomarkers. Journal of Allergy and Clinical Immunology: In Practice, 12(4), 970-982. https://doi.org/10.1016/j.jaip.2023.12.021

@article{7e554dca5bfd472ca66943382fb52b3f,

title = "Burden of Uncontrolled Severe Asthma With and Without Elevated Type-2 Inflammatory Biomarkers",

abstract = "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.",

keywords = "Allergy, Asthma, Disease burden, Eosinophil, Exacerbations, Fractional exhaled nitric oxide, Health care resource utilization, Health status, Symptom control, Type-2 inflammatory biomarkers",

author = "Bo Ding and Stephanie Chen and Eleni Rapsomaniki and Anna Quinton and William Cook and Reddel, {Helen K.} and Alberto Papi and {NOVELTY Scientific Community} and {NOVELTY Study Investigators} and {del Olmo}, Ricardo and Gary Anderson and Helen Reddel and Marcelo Rabahi and Andrew McIvor and Mohsen Sadatsafavi and Ulla Weinreich and Burgel, {Pierre R{\'e}gis} and Gilles Devouassoux and Hiromasa Inoue and Adrian Rendon and {van den Berge}, Maarten and Richard Beasley and Garc{\'i}a-Navarro, {Alvar Agusti} and Rosa Faner and Rivera, {Jos{\'e} Olaguibel} and Christer Janson and Magdalena Bili{\'n}ska-Izydorczyk and Malin Fager{\aa}s and Titti Fihn-Wikander and Stefan Franz{\'e}n and Christina Keen and Kristoffer Ostridge and James Chalmers and Timothy Harrison and Ian Pavord and David Price and Adnan Azim and Laura Belton and Bl{\'e}, {Francois Xavier} and Clement Erhard and Kerry Gairy and Rod Hughes and Glenda Lassi and Hana M{\"u}llerov{\'a} and Scott, {Ian Christopher} and Bradley Chipps and Stephanie Christenson and Barry Make and Erin Tomaszewski and Gabriel Benhabib and Ruiz, {Xavier Bocca} and Lisanti, {Raul Eduardo} and Gustavo Marino and Walter Mattarucco and Juan Nogueira and Maria Parody and Pablo Pascale and Pablo Rodriguez and Damian Silva and Graciela Svetliza and Victorio, {Carlos F.} and Rolon, {Roxana Willigs} and Anahi Ya{\~n}ez and Stuart Baines and Simon Bowler and Peter Bremner and Sheetal Bull and Patrick Carroll and Mariam Chaalan and Claude Farah and Gary Hammerschlag and Kerry Hancock and Zinta Harrington and Gregory Katsoulotos and Joshua Kim and David Langton and Donald Lee and Matthew Peters and Lakshman Prassad and Dimitar Sajkov and Francis Santiago and Simpson, {Frederick Graham} and Sze Tai and Paul Thomas and Peter Wark and {Delfini Can{\c c}ado}, {Jos{\'e} Eduardo} and Th{\'u}lio Cunha and Marina Lima and Cardoso, {Alexandre Pinto} and FitzGerald, {J. 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year = "2024",

month = apr,

doi = "10.1016/j.jaip.2023.12.021",

language = "English",

volume = "12",

pages = "970--982",

journal = "Journal of Allergy and Clinical Immunology: In Practice",

issn = "2213-2198",

publisher = "American Academy of Allergy, Asthma and Immunology",

number = "4",

}

Ding, B, Chen, S, Rapsomaniki, E, Quinton, A, Cook, W, Reddel, HK, Papi, A, NOVELTY Scientific Community, NOVELTY Study Investigators & Hancock, K 2024, 'Burden of Uncontrolled Severe Asthma With and Without Elevated Type-2 Inflammatory Biomarkers', Journal of Allergy and Clinical Immunology: In Practice, vol. 12, no. 4, pp. 970-982. https://doi.org/10.1016/j.jaip.2023.12.021

TY - JOUR

T1 - Burden of Uncontrolled Severe Asthma With and Without Elevated Type-2 Inflammatory Biomarkers

AU - Ding, Bo

AU - Chen, Stephanie

AU - Rapsomaniki, Eleni

AU - Quinton, Anna

AU - Cook, William

AU - Reddel, Helen K.

AU - Papi, Alberto

AU - NOVELTY Scientific Community

AU - NOVELTY Study Investigators

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, Adrian

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 - Lisanti, Raul Eduardo

AU - Marino, Gustavo

AU - Mattarucco, Walter

AU - Nogueira, Juan

AU - Parody, Maria

AU - Pascale, Pablo

AU - Rodriguez, Pablo

AU - Silva, Damian

AU - Svetliza, Graciela

AU - Victorio, Carlos F.

AU - Rolon, Roxana Willigs

AU - Yañez, Anahi

AU - Baines, Stuart

AU - Bowler, Simon

AU - Bremner, Peter

AU - Bull, Sheetal

AU - Carroll, Patrick

AU - Chaalan, Mariam

AU - Farah, Claude

AU - Hammerschlag, Gary

AU - Hancock, Kerry

AU - Harrington, Zinta

AU - Katsoulotos, Gregory

AU - Kim, Joshua

AU - Langton, David

AU - Lee, Donald

AU - Peters, Matthew

AU - Prassad, Lakshman

AU - Sajkov, Dimitar

AU - Santiago, Francis

AU - Simpson, Frederick Graham

AU - Tai, Sze

AU - Thomas, Paul

AU - Wark, Peter

AU - Delfini Cançado, José Eduardo

AU - Cunha, Thúlio

AU - Lima, Marina

AU - Cardoso, Alexandre Pinto

AU - FitzGerald, J. Mark

AU - Anees, Syed

AU - Bertley, John

AU - Bell, Alan

AU - Cheema, Amarjit

AU - Chouinard, Guy

AU - Csanadi, Michael

AU - Dhar, Anil

AU - Dhillon, Ripple

AU - Kanawaty, David

AU - Kelly, Allan

AU - Killorn, William

AU - Landry, Daniel

AU - Luton, Robert

AU - Mandhane, Piushkumar

AU - Pek, Bonavuth

AU - Petrella, Robert

AU - Stollery, Daniel

AU - Wang, Chen

AU - Chen, Meihua

AU - Chen, Yan

AU - Gu, Wei

AU - Christopher Hui, Kim Ming

AU - Li, Manxiang

AU - Li, Shiyue

AU - Lijun, Ma

AU - Qin, Guangyue

AU - Song, Weidong

AU - Tan, Wei

AU - Tang, Yijun

AU - Wang, Tan

AU - Wen, Fuqiang

AU - Wu, Feng

AU - Xiang, Ping Chao

AU - Xiao, Zuke

AU - Xiong, Shengdao

AU - Yang, Jinghua

AU - Yang, Jingping

AU - Zhang, Caiqing

AU - Zhang, Min

AU - Zhang, Ping

AU - Zhang, Wei

AU - Zheng, Xiaohe

AU - Zhu, Dan

AU - Bueno, Carlos Matiz

AU - Grimaldos, Fabio Bolivar

AU - Arboleda, Alejandra Cañas

AU - Molina de Salazar, Dora

AU - Bendstrup, Elisabeth

AU - Hilberg, Ole

AU - Kjellerup, Carsten

AU - Raherison, Chantal

AU - Bonniaud, Philippe

AU - Brun, Olivier

AU - Chouaid, Christos

AU - Couturaud, Francis

AU - de Blic, Jacques

AU - Debieuvre, Didier

AU - Delsart, Dominique

AU - Demaegdt, Axelle

AU - Demoly, Pascal

AU - Deschildre, Antoine

AU - Egron, Carole

AU - Falchero, Lionel

AU - Goupil, François

AU - Kessler, Romain

AU - Le Roux, Pascal

AU - Mabire, Pascal

AU - Mahay, Guillaume

AU - Martinez, Stéphanie

AU - Melloni, Boris

AU - Moreau, Laurent

AU - Riviere, Emilie

AU - Roux-Claudé, Pauline

AU - Soulier, Michel

AU - Vignal, Guillaume

AU - Yaici, Azzedine

AU - Bals, Robert

AU - Aries, Sven Philip

AU - Beck, Ekkehard

AU - Deimling, Andreas

AU - Feimer, Jan

AU - Grimm-Sachs, Vera

AU - Groth, Gesine

AU - Herth, Felix

AU - Hoheisel, Gerhard

AU - Kanniess, Frank

AU - Lienert, Thomas

AU - Mronga, Silke

AU - Reinhardt, Jörg

AU - Schlenska, Christian

AU - Stolpe, Christoph

AU - Teber, Ishak

AU - Timmermann, Hartmut

AU - Ulrich, Thomas

AU - Velling, Peter

AU - Wehgartner-Winkler, Sabina

AU - Welling, Juergen

AU - Winkelmann, Ernst Joachim

AU - Barbetta, Carlo

AU - Braido, Fulvio

AU - Cardaci, Vittorio

AU - Clini, Enrico Maria

AU - Costantino, Maria Teresa

AU - Cuttitta, Giuseppina

AU - di Gioacchino, Mario

AU - Fois, Alessandro

AU - Foschino-Barbaro, Maria Pia

AU - Gammeri, Enrico

AU - Inchingolo, Riccardo

AU - Lavorini, Federico

AU - Molino, Antonio

AU - Nucera, Eleonora

AU - Patella, Vincenzo

AU - Pesci, Alberto

AU - Ricciardolo, Fabio

AU - Rogliani, Paola

AU - Sarzani, Riccardo

AU - Vancheri, Carlo

AU - Vincenti, Rigoletta

AU - Endo, Takeo

AU - Fujita, Masaki

AU - Hara, Yu

AU - Horiguchi, Takahiko

AU - Hosoi, Keita

AU - Ide, Yumiko

AU - Inomata, Minehiko

AU - Inoue, Koji

AU - Inoue, Sumito

AU - Kato, Motokazu

AU - Kawasaki, Masayuki

AU - Kawayama, Tomotaka

AU - Kita, Toshiyuki

AU - Kobayashi, Kanako

AU - Koto, Hiroshi

AU - Nishi, Koichi

AU - Saito, Junpei

AU - Shimizu, Yasuo

AU - Shirai, Toshihiro

AU - Sugihara, Naruhiko

AU - Takahashi, Ken ichi

AU - Tashimo, Hiroyuki

AU - Tomii, Keisuke

AU - Yamada, Takashi

AU - Yanai, Masaru

AU - Rendon, Adrian

AU - Javier, Ruth Cerino

AU - Peregrina, Alfredo Domínguez

AU - Corzo, Marco Fernández

AU - Gonzalez, Efraín Montano

AU - Ramírez-Venegas, Alejandra

AU - Boersma, Willem

AU - Djamin, R. S.

AU - Eijsvogel, Michiel

AU - Franssen, Frits

AU - Goosens, Martijn

AU - Graat-Verboom, Lidwien

AU - Veen, Johannes in t.

AU - Janssen, Rob

AU - Kuppens, Kim

AU - van de Ven, Mario

AU - Bakke, Per

AU - Brunstad, Ole Petter

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 - Article

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 -

Burden of Uncontrolled Severe Asthma With and Without Elevated Type-2 Inflammatory Biomarkers

Abstract

Keywords

UN SDGs

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