Systemic sclerosis & Raynaud's

Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease

Rheumatology (Oxford)Published Subgroup analysis of the SENSCIS randomised trial and its open-label extension SENSCIS-ON

Primary result · Rate of decline in FVC (ml/year)Result — go to the resultDifference 25.3 ml/year 95% CI −28.9 to 79.6

Authors' conclusion

Patients with lcSSc may develop progressive fibrosing ILD. By targeting pulmonary fibrosis, nintedanib slows decline in lung function in patients with lcSSc and ILD.

Study context

Population
Patients with limited cutaneous systemic sclerosis (lcSSc) and interstitial lung disease (ILD) treated in the SENSCIS trial
Participants
277 patients
Comparison
Nintedanib vs placebo in patients with lcSSc and ILD
Primary endpoint
Rate of decline in FVC (ml/year)
Follow-up
52 weeks
Methodological detailsplacebo-controlled
  • Placebo-controlled

Primary result

As reported in the abstract

Difference

25.3 ml/year

95% CI −28.9 to 79.6

By group

Placebo

−74.5

SE 19.2 · ml/year

Nintedanib

−49.1

SE 19.8 · ml/year

Nintedanibvs Placebo
difference 25.3 ml/year (95% CI −28.9 to 79.6)

Further findings

Mean, ml

OutcomeNintedanibPlacebo
Mean change in FVC (249 patients with data) · week 52−39.1 (SE 22.2)−86.4 (SE 21.1)
  • Mean change in forced vital capacity (FVC) from baseline in SENSCIS-ON (183 patients with data): Placebo, then nintedanib in SENSCIS-ON mean −41.5 (SE 24.0) ml
  • Mean change in FVC from baseline in SENSCIS-ON (183 patients with data): Nintedanib continued in SENSCIS-ON mean −45.1 (SE 19.1) ml

Original publication

Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease. Rheumatology (Oxford). Published 9 June 2023. doi:10.1093/rheumatology/kead280

Composed by AI from the published abstract and checked against it. How Briefs are made →

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