Exploration of Asthma & Allergy

Table 2. Demographics and clinical characteristics in three classes of Bx

Current Bx	Anti-IgE therapy	Anti-IL-5/IL-5R therapy	Anti-IL-4R therapy	p-value
Subjects, n	19	15	19
Previously treated with anti-IgE, n	N.A.	2	5
Previously treated with anti-IL-5/IL-5R, n	0	N.A.	2
Previously treated with both anti-IgE and anti-IL-5/IL-5R, n	N.A.	N.A.	2
Demographic variables
Age, years	56.0 (43.0–71.0)	64.0 (52.0–73.0)	60.0 (52.0–69.0)	0.2081
Female, n (%)	17 (89.5%)	8 (53.3%)	13 (68.4%)	0.0548
BMI, kg/m²	20.5 (18.2–22.9)	25.8 (25.1–27.9)^**	26.4 (21.4–28.4)^*	0.0025
Age at asthma onset, years	45.0 (32.0–54.0)	42.0 (28.0–52.0)	33.0 (20.0–54.0)	0.9621
Duration of disease, year	15.3 (5.5–23.4)	23.2 (15.9–30.6)	18.1 (5.6–34.3)	0.3163
Smoking status				0.6009
Never smokers, n (%)	15 (78.9%)	10 (66.7%)	11 (57.9%)
Previous smokers, n (%)	4 (21.1%)	4 (26.7%)	7 (36.8%)
Current smokers, n (%)	0 (0.0%)	1 (6.7%)	1 (5.3%)
Indoor pet keeping, n (%)	3 (15.8%)	1 (6.7%)	7 (36.8%)	0.1154
History of comorbidities
Allergic rhinitis, n (%)	10 (52.6%)	6 (40.0%)	12 (63.2%)	0.4022
Chronic rhinosinusitis, n (%)	8 (42.1%)	7 (46.7%)	8 (42.1%)	> 0.9999
Eosinophilic chronic rhinosinusitis, n (%)	3 (15.8%)	5 (33.3%)	3 (15.8%)	0.5171
Atopic dermatitis, n (%)	0 (0.0%)	0 (0.0%)	1 (5.3%)	> 0.9999
COPD, n (%)	0 (0.0%)	2 (13.3%)	2 (10.5%)	0.3121
Type 2 inflammation markers
Pre-Bx highest BEC, cells/μL	470 (120–880)	846 (680–1,780)^*	420 (90–688)^††	0.0055
Pre-Bx highest FeNO, ppb	24.0 (12.0–48.0)	76.5 (40.5–108.8)^**	55.0 (32.0–97.0)	0.0084
Pre-Bx latest serum IgE, IU/mL	213.0 (59.2–412.0)	357.0 (95.0–1,380.0)	277.0 (70.2–1,480.0)	0.4284
Positive SPT and/or positive specific IgE, n (%)	15 (78.9%)	6 (40.0%)	14 (73.7%)	0.0448
Exacerbation
Pre-Bx exacerbation	3.0 (2.0–6.0)	3.0 (0.0–4.0)	4.0 (2.0–6.0)	0.4585
Post-Bx exacerbation	0.0 (0.0–0.0)	0.0 (0.0–0.0)	0.0 (0.0–0.0)	0.4221
Difference of exacerbation between post-Bx and pre-Bx	–3.0 (–5.0 to –2.0)	–3.0 (–4.0 to 0.0)	–3.0 (–6.0 to –2.0)	0.8149
mOCS
Pre-Bx mOCS user, n (%)	2 (10.5%)	6 (40.0%)	5 (26.3%)	> 0.9999
Post-Bx mOCS user, n (%)	1 (5.3%)	2 (13.3%)	2 (10.5%)
Lung function
Pre-Bx FEV₁ %predicted	89.2 (78.7–104.5)	77.3 (46.8–94.6)	84.2 (49.3–93.1)	0.1662
Post-Bx FEV₁ %predicted	93.6 (77.8–106.6)	85.8 (69.7–103.6)	84.1 (72.2–100.0)	0.6205

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Data are presented as median (interquartile range) for continuous variables, or n (%) for categorical variables. Statistics: Kruscal-Wallis test and Dunn’s multiple comparison test for continuous variables; Fisher’s exact test for categorical data. p < 0.05 considered statistically significant and highlighted in bold font. ^**p < 0.01, ^*p < 0.05 compared with anti-IgE; ^††p < 0.01 compared with anti-IL-5/IL-5R. BMI: body mass index; COPD: chronic obstructive pulmonary disease; Bx: biologics; BEC: blood eosinophil count; FeNO: fractional exhaled nitric oxide; mOCS: maintenance oral corticosteroid; SPT: skin prick test; FEV₁ %predicted: percent predicted forced expiratory volume in 1 second; IgE: immunoglobulin E; IL: interleukin; IL-5R: IL-5 receptor; pre-Bx exacerbation: exacerbations in 12 months before Bx initiation (/year); post-Bx exacerbation: exacerbations in 12 months before patients enrollment (/year); pre-Bx mOCS user: patients receiving mOCS in the year preceding Bx initiation; post-Bx mOCS user: patients receiving mOCS at enrollment; pre-Bx FEV₁ %predicted: FEV₁ %predicted values before biologic therapy; post-Bx FEV₁ %predicted: FEV₁ %predicted values at enrollment

Declarations

Author contributions

SM and NF: Conceptualization, Data curation, Formal analysis, Writing—original draft, Writing—review & editing. Y Kamide: Conceptualization, Data curation, Writing—review & editing. MY: Conceptualization, Data curation, Funding acquisition, Writing—review & editing. H Sugiura: Conceptualization, Funding acquisition, Supervision, Writing—review & editing. KS: Data curation, Writing—review & editing. MT: Supervision, Writing—review & editing. YO, S Kobayashi, T Sato, TE, TT, TI, HA, H Sano, Y Kyogoku, T Saito, S Konno, MS, KO: Data curation. All authors read and approved the submitted version.

Conflicts of interest

Yosuke Kamide received lecture fees from GlaxoSmithKline and AstraZeneca. Naoya Fujino has received research funding from AstraZeneca and received lecture fees from AstraZeneca and Sanofi. Mitsuhiro Yamada has received lecture fees from GlaxoSmithKline, AstraZeneca, and Sanofi. Seiichi Kobayashi has received research funding from AstraZeneca, and lecture fees from GlaxoSmithKline and AstraZeneca. Kiyoshi Sekiya received lecture fees from Kyorin, GlaxoSmithKline, AstraZeneca, and Sanofi. Tsutomu Tamada has received lecture fees from Novartis, GlaxoSmithKline, AstraZeneca and Sanofi. Tomohiro Ichikawa has received lecture fees from GlaxoSmithKline and AstraZeneca. Takuya Saito has received lecture fees from AstraZeneca. Masami Taniguchi has received research funding from GlaxoSmithKline, and lecture fees from GlaxoSmithKline, AstraZeneca and Sanofi. The rest of the authors have no conflicts of interest.

Ethical approval

The study protocol was approved by the Institutional Review Board of Tohoku University Hospital (IRB No. 2022-1-198) and complies with the Declaration of Helsinki (2024 version).

Consent to participate

Informed consent to participate in the study was obtained from all participants.

Consent to publication

Not applicable.

Availability of data and materials

The clinical datasets analyzed in the current study are available from the corresponding author on reasonable request. The original code for Sankey diagram has been deposited at Zenodo (http://doi.org/10.5281/zenodo.15256087).

Funding

This research was supported by AMED [JP23ek0410084] in the collection. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright

Publisher’s note

Open Exploration maintains a neutral stance on jurisdictional claims in published institutional affiliations and maps. All opinions expressed in this article are the personal views of the author(s) and do not represent the stance of the editorial team or the publisher.

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