Systemic sclerosis & Raynaud's

Trajectories of forced vital capacity in patients with systemic sclerosis-associated interstitial lung disease

Arthritis Res TherPublished Post-hoc analysis of the SENSCIS randomised trial and its open-label extension SENSCIS-ON

Authors' conclusion

These findings illustrate the progressive nature of SSc-ILD and support the efficacy of nintedanib in slowing decline in lung function over the long term.

Study context

Population
Patients with SSc-ILD in the SENSCIS and SENSCIS-ON trials
Participants
197 vs 231
Comparison
Continued nintedanib vs switch from placebo to nintedanib
  • Nintedanibn = 197
  • Placebon = 231reference
Primary endpoint
Trajectory of forced vital capacity (FVC) (mean decline)
Follow-up
52 weeks
Methodological detailsoff-treatment period ≤ 12 weeks between trials
  • Off-treatment period ≤ 12 weeks between trials

Primary result

As reported in the abstract

Mean decline in FVC, 52 weeks before last on-treatment measurement in SENSCIS

Nintedanib

- 41.5

mean · mL

Placebo

- 96.8

mean · mL

Further findings

Mean -, mL

OutcomeNintedanibPlacebo
Mean decline in FVC, baseline to week 52 of SENSCIS-ON (all on nintedanib)Placebo group received nintedanib in SENSCIS-ON58.342.8

Original publication

Trajectories of forced vital capacity in patients with systemic sclerosis-associated interstitial lung disease. Arthritis Res Ther. Published 21 March 2025. doi:10.1186/s13075-025-03524-9

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