Methods
- Inclusion criteria for the SENSCIS trial included: SSc with first non-Raynaud symptom <7 years before screening, FVC ≥40% predicted and diffusion capacity of the lung for carbon monoxide (DLco) 30–89% predicted.
- Subjects had fibrotic ILD of ≥10% extent on an HRCT scan taken in the last ≤12 months, confirmed by central review. The extent of fibrotic ILD was assessed visually in the whole lung to the nearest 5%. The assessment did not include pure (non-fibrotic) ground glass opacities.
- Subjects on prednisone ≤10 mg/day and/or stable therapy with mycophenolate or methotrexate for ≥6 months prior to randomization were allowed to participate.
- Subjects were randomized 1:1 to receive nintedanib or placebo.
Analyses
- We analyzed the rate of decline in FVC (mL/year) over 52 weeks and adverse events in subjects with limited and extensive ILD at baseline.
- We also analyzed:
- The rate of decline in FVC (mL/year) over 52 weeks in subgroups by extent of fibrotic ILD on HRCT (≥30% and <30%) and FVC (<70% and ≥70% predicted) at baseline
- The proportion of subjects with limited and extensive ILD at baseline who had categorical declines in FVC or death over 52 weeks.
- Interaction p-values were calculated to assess potential heterogeneity in the treatment effect of nintedanib versus placebo between subgroups. No adjustment for multiplicity was made.