Novel Pulmonary Imaging Biomarkers and Cutaneous Gene Expression Subsetting for Patient Selection and Outcome Assessment in the Dasatinib Treatment of Systemic Sclerosis-associated Interstitial Lung Disease
There are no effective treatments or clinical response markers for systemic sclerosis (SSc). We sought to assess the potential of novel imaging biomarkers and gene expression profiling approaches in a clinical trial of the tyrosine kinase inhibitor dasatinib in SSc patients with interstitial lung disease (SSc-ILD).
Overall design
Patients were enrolled in a single-arm open-label trial of dasatinib. Primary objective was to assess safety and pharmacokinetics. Secondary and exploratory outcomes included clinical assessments, quantitative high-resolution computed tomography (HRCT) of the chest, serum biomarkers, and intrinsic gene expression subset assignments in skin.