Methods

Subjects in the SENSCIS trial had SSc with first non-Raynaud symptom <7 years before screening, fibrotic ILD of ≥10% extent on an HRCT scan, FVC ≥40% predicted and DLco 30–89% predicted.
Subjects taking 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 to receive nintedanib or placebo until the last subject had reached week 52 but for ≤100 weeks.
Based on the distribution of BMI at baseline, we analysed outcomes in subgroups with baseline BMI above and below the median (25 kg/m²). In these subgroups, we analyzed the rate of decline in FVC (mL/year), categorical declines in FVC, and time to absolute decline in FVC ≥10% predicted or death. The number of subjects who were underweight (BMI<18.5 kg/m²) at baseline (n=21) was too low for this subgroup to be analysed separately.