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.
Burden of Uncontrolled Severe Asthma With and Without Elevated Type-2 Inflammatory Biomarkers / Ding, Bo; Chen, Stephanie; Rapsomaniki, Eleni; Quinton, Anna; Cook, William; Reddel, Helen K.; Papi, Alberto; del Olmo, Ricardo; Anderson, Gary; Reddel, Helen; Rabahi, Marcelo; Mcivor, Andrew; Sadatsafavi, Mohsen; Weinreich, Ulla; Burgel, Pierre-Régis; Devouassoux, Gilles; Papi, Alberto; Inoue, Hiromasa; Rendon, Adrián; van den Berge, Maarten; Beasley, Richard; García-Navarro, Alvar Agusti; Faner, Rosa; Rivera, José Olaguibel; Janson, Christer; Bilińska-Izydorczyk, Magdalena; Fagerås, Malin; Fihn-Wikander, Titti; Franzén, Stefan; Keen, Christina; Ostridge, Kristoffer; Chalmers, James; Harrison, Timothy; Pavord, Ian; Price, David; Azim, Adnan; Belton, Laura; Blé, Francois-Xavier; Erhard, Clement; Gairy, Kerry; Hughes, Rod; Lassi, Glenda; Müllerová, Hana; Rapsomaniki, Eleni; Scott, Ian Christopher; Chipps, Bradley; Christenson, Stephanie; Make, Barry; Tomaszewski, Erin; del Olmo, Ricardo; Benhabib, Gabriel; Ruiz, Xavier Bocca; Lisanti, Raul Eduardo; Marino, Gustavo; Mattarucco, Walter; Nogueira, Juan; Parody, Maria; Pascale, Pablo; Rodriguez, Pablo; Silva, Damian; Svetliza, Graciela; Victorio, Carlos F.; Rolon, Roxana Willigs; Yañez, Anahi; Reddel, Helen; Baines, Stuart; Bowler, Simon; Bremner, Peter; Bull, Sheetal; Carroll, Patrick; Chaalan, Mariam; Farah, Claude; Hammerschlag, Gary; Hancock, Kerry; Harrington, Zinta; Katsoulotos, Gregory; Kim, Joshua; Langton, David; Lee, Donald; Peters, Matthew; Prassad, Lakshman; Sajkov, Dimitar; Santiago, Francis; Simpson, Frederick Graham; Tai, Sze; Thomas, Paul; Wark, Peter; Rabahi, Marcelo; Delfini Cançado, José Eduardo; Cunha, Thúlio; Lima, Marina; Cardoso, Alexandre Pinto; Fitzgerald, J. Mark; Mcivor, Andrew; Anees, Syed; Bertley, John; Bell, Alan; Cheema, Amarjit; Chouinard, Guy; Csanadi, Michael; Dhar, Anil; Dhillon, Ripple; Kanawaty, David; Kelly, Allan; Killorn, William; Landry, Daniel; Luton, Robert; Mandhane, Piushkumar; Pek, Bonavuth; Petrella, Robert; Stollery, Daniel; Wang, Chen; Chen, Meihua; Chen, Yan; Gu, Wei; Christopher Hui, Kim Ming; Li, Manxiang; Li, Shiyue; Lijun, Ma; Qin, Guangyue; Song, Weidong; Tan, Wei; Tang, Yijun; Wang, Tan; Wen, Fuqiang; Wu, Feng; Xiang, Pingchao; Xiao, Zuke; Xiong, Shengdao; Yang, Jinghua; Yang, Jingping; Zhang, Caiqing; Zhang, Min; Zhang, Ping; Zhang, Wei; Zheng, Xiaohe; Zhu, Dan; Bueno, Carlos Matiz; Grimaldos, Fabio Bolivar; Arboleda, Alejandra Cañas; Molina de Salazar, Dora; Weinreich, Ulla; Bendstrup, Elisabeth; Hilberg, Ole; Kjellerup, Carsten; Burgel, Pierre-Régis; Devouassoux, Gilles; Raherison, Chantal; Bonniaud, Philippe; Brun, Olivier; Chouaid, Christos; Couturaud, Francis; de Blic, Jacques; Debieuvre, Didier; Delsart, Dominique; Demaegdt, Axelle; Demoly, Pascal; Deschildre, Antoine; Egron, Carole; Falchero, Lionel; Goupil, François; Kessler, Romain; Le Roux, Pascal; Mabire, Pascal; Mahay, Guillaume; Martinez, Stéphanie; Melloni, Boris; Moreau, Laurent; Riviere, Emilie; Roux-Claudé, Pauline; Soulier, Michel; Vignal, Guillaume; Yaici, Azzedine; Bals, Robert; Aries, Sven Philip; Beck, Ekkehard; Deimling, Andreas; Feimer, Jan; Grimm-Sachs, Vera; Groth, Gesine; Herth, Felix; Hoheisel, Gerhard; Kanniess, Frank; Lienert, Thomas; Mronga, Silke; Reinhardt, Jörg; Schlenska, Christian; Stolpe, Christoph; Teber, Ishak; Timmermann, Hartmut; Ulrich, Thomas; Velling, Peter; Wehgartner-Winkler, Sabina; Welling, Juergen; Winkelmann, Ernst-Joachim; Papi, Alberto; Barbetta, Carlo; Braido, Fulvio; Cardaci, Vittorio; Clini, Enrico Maria; Costantino, Maria Teresa; Cuttitta, Giuseppina; di Gioacchino, Mario; Fois, Alessandro; Foschino-Barbaro, Maria Pia; Gammeri, Enrico; Inchingolo, Riccardo; Lavorini, Federico; Molino, Antonio; Nucera, Eleonora; Patella, Vincenzo; Pesci, Alberto; Ricciardolo, Fabio; Rogliani, Paola; Sarzani, Riccardo; Vancheri, Carlo; Vincenti, Rigoletta; Inoue, Hiromasa; Endo, Takeo; Fujita, Masaki; Hara, Yu; Horiguchi, Takahiko; Hosoi, Keita; Ide, Yumiko; Inomata, Minehiko; Inoue, Koji; Inoue, Sumito; Kato, Motokazu; Kawasaki, Masayuki; Kawayama, Tomotaka; Kita, Toshiyuki; Kobayashi, Kanako; Koto, Hiroshi; Nishi, Koichi; Saito, Junpei; Shimizu, Yasuo; Shirai, Toshihiro; Sugihara, Naruhiko; Takahashi, Ken-ichi; Tashimo, Hiroyuki; Tomii, Keisuke; Yamada, Takashi; Yanai, Masaru; Rendon, Adrian; Javier, Ruth Cerino; Peregrina, Alfredo Domínguez; Corzo, Marco Fernández; Gonzalez, Efraín Montano; Ramírez-Venegas, Alejandra; van den Berge, Maarten; Boersma, Willem; Djamin, R. S.; Eijsvogel, Michiel; Franssen, Frits; Goosens, Martijn; Graat-Verboom, Lidwien; Veen, Johannes in 't; Janssen, Rob; Kuppens, Kim; van de Ven, Mario; Bakke, Per; Brunstad, Ole Petter; Einvik, Gunnar; Høines, Kristian Jong; Khusrawi, Alamdar; Oien, Torbjorn; Yoon, Ho Joo; Chang, Yoon-Seok; Cho, Young Joo; Hwang, Yong Il; Kim, Woo Jin; Koh, Young-Il; Lee, Byung-Jae; Lee, Kwan-Ho; Lee, Sang-Pyo; Lee, Yong Chul; Lim, Seong Yong; Min, Kyung Hun; Oh, Yeon-Mok; Park, Choon-Sik; Park, Hae-Sim; Park, Heung-Woo; Rhee, Chin Kook; Yoon, Hyoung-Kyu; García-Navarro, Alvar Agusti; Rivera, José Olaguibel; Andújar, Rubén; Anoro, Laura; García, María Buendía; Mozo, Paloma Campo; Campos, Sergio; Maldonado, Francisco Casas; Martínez, Manuel Castilla; Serrano, Carolina Cisneros; Casanova, Lorena Comeche; Corbacho, Dolores; Del Campo Matías, Felix; Echave-Sustaeta, Jose; Corral, Gloria Francisco; Setién, Pedro Gamboa; Clemente, Marta García; Núñez, Ignacio García; Robaina, Jose García; Salmones, Mercedes García; Marín Trigo, Jose Maria; Fernandez, Marta Nuñez; Palomo, Sara Nuñez; Pérez de Llano, Luis; Bastida, Ana Pueyo; Rañó, Ana; González-Moro, José Rodríguez; Reig, Albert Roger; Garrido, José Velasco; Janson, Christer; Curiac, Dan; Lif-Tiberg, Cornelia; Luts, Anders; Råhlen, Lennart; Rustscheff, Stefan; Harrison, Timothy; Adams, Frances; Bradman, Drew; Broughton, Emma; Cosgrove, John; Flood-Page, Patrick; Fuller, Elizabeth; Hartley, David; Hattotuwa, Keith; Jones, Gareth; Lewis, Keir; Mcgarvey, Lorcan; Morice, Alyn; Pandya, Preeti; Patel, Manish; Roy, Kay; Sathyamurthy, Ramamurthy; Thiagarajan, Swaminathan; Turner, Alice; Vestbo, Jorgen; Wedzicha, Wisia; Wilkinson, Tom; Wilson, Pete; Chipps, Bradley; Al-Asadi, Lo'Ay; Anholm, James; Averill, Francis; Bansal, Sandeep; Baptist, Alan; Campbell, Colin; Campos, Michael A.; Crook, Gretchen; Deleon, Samuel; Eid, Alain; Epstein, Ellen; Fritz, Stephen; Harris, Hoadley; Hewitt, Mitzie; Holguin, Fernando; Hudes, Golda; Jackson, Richard; Kaufman, Alan; Kaufman, David; Klapholz, Ari; Krishna, Harshavardhan; Lee, Daria; Lin, Robert; Maselli-Caceres, Diego; Mehta, Vinay; Moy, James N.; Nwokoro, Ugo; Parikh, Purvi; Parikh, Sudhir; Perrino, Frank; Ruhlmann, James; Sassoon, Catherine; Settipane, Russell A.; Sousa, Daniel; Sriram, Peruvemba; Wachs, Richard. - In: JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY. IN PRACTICE. - ISSN 2213-2198. - 12:4(2024), pp. 970-982. [10.1016/j.jaip.2023.12.021]
Burden of Uncontrolled Severe Asthma With and Without Elevated Type-2 Inflammatory Biomarkers
Sarzani, RiccardoMembro del Collaboration Group
;
2024-01-01
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.File | Dimensione | Formato | |
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