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 taken in the last ≤12 months, 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 1:1 to receive nintedanib or placebo until the last subject had reached week 52 but for ≤100 weeks.
We analyzed the rate of decline in FVC (mL/year), categorical declines in FVC, and time to composite outcomes based on lung function decline and death in subgroups based on time since onset of first non-Raynaud symptom at randomization (<3, 3 to ≤5, >5 years). 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.
Adverse events are presented descriptively.