Results
Baseline characteristics of subgroups by fibrotic pattern on HRCT
Mean or % of subjects.
ILD diagnoses in subgroups by fibrotic pattern on HRCT
*Included ILD associated with rheumatoid arthritis, systemic sclerosis, and mixed connective tissue disease, plus subjects with an autoimmune disease noted in the “Other fibrosing ILDs” category of the case report form. †Included sarcoidosis, exposure-related ILDs and selected terms in the “Other fibrosing ILDs” category of the case report form.
Annual rate of decline in FVC (mL/year)
- In subjects who received placebo, the rate of decline in FVC over 52 weeks was numerically greater in subjects with a UIP-like fibrotic pattern on HRCT than in those with other fibrotic patterns on HRCT (−209.2 [SE 19.1] versus −155.4 [23.6] mL/year).
- 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).
- The relative treatment effect of nintedanib on the annual rate of decline in FVC was consistent between the subgroups by fibrotic pattern on HRCT:
Relative effect of nintedanib versus placebo on the annual rate of decline in FVC (mL/year) over 52 weeks in subgroups by fibrotic pattern on HRCT
Observed change in FVC over 52 weeks
- The observed change from baseline over time showed clear separation between the nintedanib and placebo groups, both in subjects with a UIP-like fibrotic pattern on HRCT and in subjects with other fibrotic patterns on HRCT:
Observed change from baseline in FVC (mL) over 52 weeks in subgroups by fibrotic pattern on HRCT
Change in K-BILD questionnaire total score at week 52
- There was no meaningful change in total score on the K-BILD questionnaire with nintedanib versus placebo in either subgroup by fibrotic pattern on HRCT:
Change from baseline in K-BILD questionnaire total score at week 52 in subgroups by fibrotic pattern on HRCT
Treatment-by-visit-by-subgroup interaction p=0.76.
K-BILD questionnaire total scores range from 0–100, with higher scores representing better health status.
Time to first acute exacerbation of ILD or death, and absolute decline in FVC ≥10% predicted or death
Adverse events
- In both subgroups by HRCT pattern, the adverse event profile of nintedanib was consistent with the overall population:
Most frequent gastrointestinal, weight loss and hepatic adverse events (reported irrespective of causality) in subgroups by fibrotic pattern on HRCT
Gastrointestinal, weight loss and liver enzyme adverse events, coded using MedDRA preferred terms, reported in >10% of subjects in any of the subgroups shown. Data are % of subjects with ≥1 such adverse event, reported over 52 weeks (or until 28 days after last trial drug intake in subjects who discontinued trial drug before week 52). ALT, alanine aminotransferase; AST, aspartate aminotransferase.
- Serious adverse events occurred in 30.6% and 34.9% of subjects treated with nintedanib, compared with 37.4% and 26.4% of subjects who received placebo, in the subgroups with a UIP-like fibrotic pattern on HRCT and other fibrotic patterns on HRCT, respectively.
- Fatal adverse events occurred in 3.4% and 3.2% of subjects treated with nintedanib, compared with 7.8% and 0.8% of subjects who received placebo, in the subgroups with a UIP-like fibrotic pattern on HRCT and other fibrotic patterns on HRCT, respectively.