부산대학교 도서관

Background Several studies have suggested that the progression of fibrosing ILDs is more rapid in patients with a usual interstitial pneumonia (UIP) pattern on HRCT. In the INBUILD trial, nintedanib slowed the rate of decline in FVC in subjects with fibrosing ILDs and a progressive phenotype. We assessed the effect of nintedanib in subgroups by HRCT pattern at baseline. Methods In the INBUILD trial, subjects (n=663) with a progressive fibrosing ILD were randomized to receive nintedanib or placebo. Randomization was stratified by HRCT pattern (UIP-like fibrotic pattern or other fibrotic patterns) based on central review. In pre-specified analyses, we assessed the effects of nintedanib in subgroups of subjects with a UIP-like fibrotic pattern and other fibrotic patterns on HRCT at baseline. Results At baseline, 62.1% of total subjects had a UIP-like fibrotic pattern on HRCT. In subjects who received placebo, the adjusted mean annual rate (SE) of decline in FVC was -209.2 (19.1) mL/year in subjects with a UIP-like fibrotic pattern on HRCT and -155.4 (23.6) mL/year in subjects with other fibrotic patterns on HRCT. The difference between the nintedanib and placebo groups in the annual rate of decline in FVC was 127.8 (95% CI: 74.3, 181.2) mL/year in subjects with a UIP-like fibrotic pattern on HRCT and 75.4 (95% CI: 9.5, 141.4) mL/year in subjects with other fibrotic patterns on HRCT (treatment-by-subgroup-by-time interaction p=0.23) (Table). The effects of nintedanib vs placebo on change from baseline in K-BILD questionnaire total score at week 52, time to acute exacerbation of ILD or death over 52 weeks, and time to death over 52 weeks between the subgroups by HRCT pattern are shown in the Table. Conclusions In the INBUILD trial, the effect of nintedanib on slowing the rate of FVC decline was consistent regardless of fibrotic pattern on HRCT.