A sensitivity analysis for biologic-naïve patients
| Outcome | Full cohort (n = 53) | Biologic-naïve (n = 44) | p-value |
|---|---|---|---|
| Post-Bx exacerbation | 0.0 (0.0–0.0) | 0.0 (0.0–0.0) | 0.8739 |
| Post-Bx mOCS user, n (%) | 6 (11.3%) | 4 (9.1%) | > 0.9999 |
| Post-Bx FEV1 %predicted | 86.3 (74.8–102.5) | 86.1 (72.7–101.9) | 0.7983 |
Data are presented as median (interquartile range) for continuous variables, or n (%) for categorical variables. Statistics: Mann-Whitney test for continuous variables; Fisher’s exact test for categorical data. Bx: biologics; FEV1 %predicted: percent predicted forced expiratory volume in 1 second; mOCS: maintenance oral corticosteroid; post-Bx exacerbation: exacerbations in 12 months before patients’ enrollment (/year); post-Bx mOCS user: patients receiving mOCS at enrollment; post-Bx FEV1 %predicted: FEV1 %predicted values at enrollment
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.
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.
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).
Informed consent to participate in the study was obtained from all participants.
Not applicable.
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).
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.
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