Systemic sclerosis & Raynaud's

Outcomes in Systemic Sclerosis–Associated Interstitial Lung Disease Based on Serological Profiles With a Focus on Anticentromere and Anti-RNA Polymerase III Antibodies

J RheumatolPublished Post hoc analysis of the SENSCIS randomised trial

Authors' conclusion

These analyses of data from the SENSCIS trial suggest that patients with SSc-ILD who are ACA positive or ARA positive can experience progression of SSc-ILD. Patients negative for ACA, ARA, and ATA had a higher rate of progression than the overall trial population

Study context

Population
Patients with SSc-ILD in the SENSCIS trial (nintedanib vs placebo) with baseline serological evaluation
Comparison
Rate of forced vital capacity (FVC) decline in serological subsets (anticentromere antibody (ACA)+, ARA+, ACA/ARA/ATA-negative) vs overall SENSCIS population, by nintedanib or placebo
  • ACA positiven = 32
  • ARA positiven = 98
  • ACA, ARA, ATA negativen = 127
Primary endpoint
Rate of decline in FVC
Follow-up
52 weeks
Methodological detailsserological subsets
  • Serological subsets

Primary result

As reported in the abstract

Adjusted rate (SE) of FVC decline, placebo

ACA positive

−31.2

adjusted rate · SE 41.5 · mL/year

ARA positive

−64.7

adjusted rate · SE 35.1 · mL/year

ACA, ARA, ATA negative

−115.6

adjusted rate · SE 35.4 · mL/yr

Overall SENSCIS population

−93.3

adjusted rate · SE 13.5 · mL/yr

Further findings

Adjusted rate, mL/yr

OutcomeACA, ARA, ATA negativeOverall SENSCIS population
Adjusted rate (SE) of FVC decline, nintedanib · 52 weeks−91.8 (SE 34.3)−52.4 (SE 13.8)

Adjusted rate (SE) of FVC decline, nintedanib · 52 weeks

ACA/ARA/ATA negative: numerically greater decline than overall population

Original publication

Outcomes in Systemic Sclerosis–Associated Interstitial Lung Disease Based on Serological Profiles With a Focus on Anticentromere and Anti-RNA Polymerase III Antibodies. J Rheumatol. Published 15 April 2025. doi:10.3899/jrheum.2024-1063

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