Systemic sclerosis & Raynaud's
Continued nintedanib in patients with systemic sclerosis-associated interstitial lung disease: 3-year data from SENSCIS-ON
Authors' conclusion
The safety profile of nintedanib over 148 weeks of SENSCIS-ON was consistent with that reported in SENSCIS. Changes in FVC during SENSCIS and SENSCIS-ON supported a continued effect of nintedanib on slowing the decline in lung function, but showed continued progression of SSc-ILD.
Study context
- Population
- Patients with SSc-ILD treated with open-label nintedanib in SENSCIS-ON, the extension of SENSCIS231 of initiated group from SENSCIS
- Participants
- 197 vs 247
- Comparison
- Continued nintedanib vs initiated nintedanib
- Continued nintedanibn = 197
- Initiated nintedanibn = 247
- Primary endpoint
- Adverse events and changes in forced vital capacity (FVC)
- Follow-up
- 148 weeks
Primary result
As reported in the abstract
Change in FVC, mean · week 148
Continued nintedanib
−189.1
mean · SE 29.5 · mL
Initiated nintedanib
−126.4
mean · SE 26.4 · mL
Safety
Diarrhoea (most frequent adverse event) · 148 weeks
≥1 dose reduction · 148 weeks
≥1 treatment interruption · 148 weeks
Adverse events leading to treatment discontinuation · 148 weeks
Original publication
Continued nintedanib in patients with systemic sclerosis-associated interstitial lung disease: 3-year data from SENSCIS-ON. RMD Open. Published 23 February 2025. doi:10.
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