Methods
The INPULSIS trials3
- The INPULSIS trials enrolled patients with a diagnosis of IPF, FVC ≥50% predicted, forced expiratory volume in 1 second (FEV1)/FVC ratio of ≥70%, and diffusing capacity of the lung for carbon monoxide (DLco) 30-79% predicted. Patients with emphysema evident on an HRCT scan were eligible to participate.
- Patients were randomized to receive nintedanib 150 mg bid or placebo for 52 weeks.
- FVC was measured at baseline and at weeks 2, 4, 6, 12, 24, 36 and 52.
Combined pulmonary fibrosis and emphysema (CPFE) index2
Image
Analysis
- In post-hoc analyses, we analyzed the following in subgroups by CPFE index-estimated extent of emphysema <10% versus ≥10% at baseline:
- Annual rate of decline in FVC (mL/year)
- Change from baseline in St George’s Respiratory Questionnaire (SGRQ) total score at week 52
- Time to absolute decline in FVC ≥5% predicted or death over 52 weeks
- Time to absolute decline in FVC ≥10% predicted or death over 52 weeks.
- Interaction p-values were calculated to assess potential heterogeneity in the treatment effect of nintedanib versus placebo between the subgroups. No adjustment for multiplicity was made.