Methods
Trial design
- Subjects in the INBUILD trial had an ILD other than IPF, diagnosed according to the investigator’s usual clinical practice; diffuse fibrosing interstitial lung disease (reticular abnormality with traction bronchiectasis, with or without honeycombing) of >10% extent on HRCT; FVC ≥45% predicted; DLco ≥30%–<80% predicted.
- Subjects met ≥1 of the following criteria for ILD progression in the 24 months before screening, despite management deemed appropriate in clinical practice:
- Subjects were randomized 1:1 to receive nintedanib 150 mg bid or placebo, stratified by HRCT pattern (usual interstitial pneumonia [UIP]-like fibrotic pattern or other fibrotic patterns) based on central review.
Analyses
- In pre-specified analyses, we assessed the rate of decline in FVC (mL/year) over 52 weeks in subgroups based on the following baseline characteristics:
- Sex
- Age (<65, ≥65 years)
- Race (White, Asian, Black/African-American)
- FVC (≤70, >70% predicted)
- ILD diagnosis: hypersensitivity pneumonitis; autoimmune ILDs; idiopathic non-specific interstitial pneumonia (iNSIP); unclassifiable idiopathic interstitial pneumonia (IIP); other ILDs.
- Interaction p-values were calculated to assess potential heterogeneity in the treatment effect of nintedanib versus placebo across the subgroups. No adjustment for multiplicity was made.