Effects of nintedanib in patients with systemic sclerosis-associated ILD (SSc-ILD) and differing extents of lung fibrosis: the SENSCIS trial

Abstract

Background: In the SENSCIS trial in patients with SSc-ILD, nintedanib reduced the annual rate of FVC decline (mL/year) vs placebo (primary endpoint). There was no significant difference between groups in change in modified Rodnan skin score (mRSS) or St George’s Respiratory Questionnaire (SGRQ) total score (key secondary endpoints) at week 52. Aim: Assess whether extent of lung fibrosis influenced the efficacy of nintedanib. Methods: Subjects with SSc-ILD, ≥10% fibrosis of the lungs on HRCT and FVC ≥40% predicted were randomised to nintedanib 150 mg bid or placebo. We analysed primary and key secondary endpoints in subgroups with extent of lung fibrosis Results: Mean±SD extent of fibrosis at baseline was 36.8±21.8% in the nintedanib group (n=288) and 35.2±20.7% in the placebo group (n=288); 80.2% and 74.3% of subjects in these groups, respectively, had ≥20% fibrosis. The effect of nintedanib on FVC decline was numerically more pronounced in subjects with ≥20% fibrosis, but the treatment-by-time-by-subgroup interaction did not reach statistical significance. A more pronounced increase in SGRQ total score with nintedanib vs placebo was observed in patients with Conclusion: Nintedanib reduced ILD progression in patients with SSc-ILD irrespective of extent of lung fibrosis at baseline.