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 <20% vs ≥20% at baseline.
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 <20% fibrosis. Changes in mRSS were similar in both subgroups.
Conclusion: Nintedanib reduced ILD progression in patients with SSc-ILD irrespective of extent of lung fibrosis at baseline.
Footnotes
Cite this article as: European Respiratory Journal 2019; 54: Suppl. 63, PA5193.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2019