Biomarker profile and disease burden associated with intermittent and long-term oral corticosteroid use in patients with severe asthma prior to biologic initiation in real-life (STAR).
Journal
The World Allergy Organization journal
Journal Volume
18
Journal Issue
7
Start Page
Article number 101066
ISSN
1939-4551
Date Issued
2025-07
Author(s)
Schleich, Florence
Larenas-Linnemann, Désirée
Altraja, Alan
Pérez de Llano, Luis
Kostikas, Konstantinos
Sadatsafavi, Mohsen
Bourdin, Arnaud
Alton Pleasants, Roy
Hew, Mark
Chen, Wenjia
Jiménez-Maldonado, Libardo
Couillard, Simon
Suppli Ulrik, Charlotte
Bulkhi, Adeeb A
Tsai, Ming-Ju
Christoff, George C
Papadopoulos, Nikolaos G
Pfeffer, Paul E
Ryan, Dermot
Bergeron, Celine
Al-Ahmad, Mona S
Dorscheid, Delbert R
Wang, Eileen
Blakey, John D
Cochrane, Belinda
Peters, Matthew J
Popov, Todor A
Torres-Duque, Carlos A
Hansen, Susanne
Puggioni, Francesca
Fletton, Kirsty
Salameh, Laila
Middleton, Peter G
Márcio Pitrez, Paulo
Kook Rhee, Chin
Denton, Eve
Chapman, Kenneth R
Lehtimäki, Lauri
Murray, Ruth B
Sheu, Chau-Chyun
Jackson, David J
Al-Lehebi, Riyad
Siyue Koh, Mariko
Mahboub, Bassam
Ardusso, Ledit R F
Gogali, Athena
Canonica, Giorgio Walter
Kuna, Piotr
Sivori, Martin
Louis, Renaud
Abercromby, Shelley
Guida, Giuseppe
Aarli, Bernt Bøgvald
Beastall, Aaron
Carter, Victoria
Scelo, Ghislaine
Townend, John
Cosio, Borja G
Patel, Pujan H
Goh, Celine Yun Yi
Csoma, Zsuzsanna
Upham, John W
Fonseca, João A
Gibson, Peter G
Jenkins, Christine
Brusselle, Guy G
Chèvremont, Anne
Côté, Andréanne
Celis-Preciado, Carlos Andrés
Solarte, Ivan
Porsbjerg, Celeste M
Sverrild, Asger
Kauppi, Paula
Loukides, Stelios
Makris, Michael P
Papaioannou, Andriana I
Heffler, Enrico
Chan, Jeffrey Shi Kai
Joo, Hyonsoo
Heaney, Liam G
Cheng, Wei-Han
Lugogo, Njira
Wechsler, Michael E
Chaves Loureiro, Cláudia
Rodríguez-Cáceres, Bellanid
Nagano, Tatsuya
Wang, Zhixiao
Máspero, Jorge
Saldarini, Fernando
Stok, Ana María
Yañez, Anahi
Bardin, Philip G
Bosnic-Anticevich, Sinthia Z
Navaratnam, Vidya
Bhutani, Mohit
Lougheed, M Diane
Melenka, Lyle
Bakakos, Petros
Exarchos, Konstantinos P
Ladias, Aggelos A
Lúdvíksdóttir, Dóra
Iwanaga, Takashi
Contreras Contreras, Elvia Angelica
Lehmann, Sverre
Ferreira, José Alberto
Gall, Rebecca
Fu, Pin-Kuei
Perng, Diahn-Warng
Hoyte, Flavia
Katial, Rohit
Björnsdóttir, Unnur S
Taillé, Camille
Taube, Christian
Cushen, Breda
Bulathsinhala, Lakmini
Bjermer, Leif
Price, David B
Abstract
Background: Asthma characterization using blood eosinophil count (BEC) (among other biomarkers and clinical indices) is recommended in severe asthma (SA), but the masking effect of oral corticosteroids (OCS), makes this challenging. Aim: Our aim was to explore the effect of OCS use (both intermittent [iOCS] and long-term [LTOCS]) prior to biologic initiation on SA phenotype and biomarker profile in real-life and to characterize the burden of SA among patients prescribed LTOCS by biomarker profile. Methods: This was a registry-based cohort study, including data from 23 countries collected between 2003 and 2023 and shared with the Internatonal Severe Asthma Registry (ISAR). Patients with SA were categorized into 3 cohorts, those with: (i) no prescription for OCS, (ii) prescription(s) for iOCS (ie, ≤90 days in previous 12-months, usually short courses for exacerbations), and (iii) prescriptions for LTOCS (ie, >90 days in previous 12-months). Biomarker distribution (ie, BEC, fractional exhaled nitric oxide [FeNO], and total Immunoglobulin E [IgE]) were quantified in the year prior to biologic initiation in patients with SA according to OCS prescription pattern. Phenotypes were characterized for those prescribed LTOCS according to BEC cut-off (<150 and ≥ 150 cells/μL). Results: Of 4305 patients included, 5.0% (n = 215), 54.1% (n = 2330) and 40.9% (n = 1760) were prescribed no OCS, iOCS, and LTOCS, respectively. The BEC distribution varied by prescription pattern and LTOCS dose (<5 mg to ≥20 mg/day); BEC was <150 cells/μL in 28.6% (n = 369/1288) of LTOCS patients, compared to 19.5% (n = 284/1460) of iOCS patients and 14.0% (n = 21/150) of those in the no OCS group. Median BEC was also significantly lower in the LTOCS versus the iOCS group (310 vs 400 cells/μL; p < 0.001). A similar pattern was noted for IgE, but not FeNO. Among LTOCS patients with BEC <150 cells/μL, 39.9% experienced ≥4 exacerbations, 75.1% had uncontrolled asthma symptoms and 55.9% had evidence of persistent airflow obstruction (compared with 40.9%, 76.2% and 59.5% of those with BEC ≥150 cells/μL, respectively). Conclusions: OCS, whether prescribed intermittently or long term, affect BEC distribution potentially leading to heightened risk of phenotype misclassification and influencing subsequent treatment decisions. FeNO appears to be less susceptible to OCS-induced suppression. Disease burden was high for those in the LTOCS group and was high independent of dose and BEC. Our findings highlight the importance of considering OCS use, even intermittent use, when characterizing SA, and suggests the need for earlier phenotyping and alternative treatment strategies for LTOCS patients with low BEC.
Subjects
BEC
Blood eosinophil count
FeNO
Fractional exhaled nitric oxide
IgE
Immunoglobulin E
Intermittent
Long-term
SDGs
Type
journal article