Progressive fibrosing interstitial lung disease
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients and study period: We included patients with progressive fibrosing interstitial lung disease (PF-ILD) who had received nintedanib at Yamanashi Red Cross Hospital between September 1, 2015 and February 28, 2026. Baseline laboratory data: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count were required to be measured within 30 days before or after nintedanib initiation; when multiple measurements were available within this window, the value closest to the initiation date was used. Follow-up availability: Patients were required to have ascertainable follow-up after nintedanib initiation, with either the date of death or the date of last confirmed clinical contact documented. Consent: Informed consent was obtained using an opt-out procedure.
Exclusion criteria
Exclusion criteria: Baseline laboratory data: AST, ALT, and platelet count were not measured within 30 days of nintedanib initiation. AST, ALT, and platelet count obtained within 30 days of nintedanib initiation were judged by the treating clinician to reflect an acute illness (i.e., not representative of baseline status). Drugs: Use of any antifibrotic agent within the 90 days prior to cohort entry. Consent: Informed consent could not be obtained via the opt-out procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| delta FVC from baseline (ml/year) (liner mixed model) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first acute exacerbation or death Correlation between KL-6 and FIB-4 index (Spearman) | — |
Countries
Japan
Contacts
Yamanashi Red Cross Hospital Department of Medicine, Division of Respiratory Medicine