Conclusions
- The change in FVC in patients who received nintedanib over 52 weeks of SENSCIS-ON was similar to the change in FVC in patients who received nintedanib over 52 weeks of the SENSCIS trial.
- The safety profile of nintedanib over longer-term use was consistent with that reported over 52 weeks.
- These findings support a clinically meaningful benefit of nintedanib in slowing the progression of SSc-ILD with a safety profile that can be managed by dose adjustments.