Systemic sclerosis & Raynaud's
Circulating biomarkers in patients with systemic sclerosis–associated interstitial lung disease in the SENSCIS trial
Authors' conclusion
Applying a dichotomised threshold for KL-6 can aid in identifying patients with SSc-ILD with more progressive ILD. Nintedanib reduced levels of the epithelial dysfunction marker, CA-125, and collagen synthesis epitope, pro-C6.
Study context
- Population
- Patients with SSc-ILD, ≤7 years since first non-Raynaud symptom, in the SENSCIS trial
- Comparison
- Nintedanib vs placebo; baseline biomarker levels and forced vital capacity (FVC) decline / modified Rodnan Skin Score (mRSS) change in the placebo group
- Primary endpoint
- Associations between baseline biomarker levels and decline in FVC over 52 weeks (placebo group)
- Follow-up
- 52 weeks
Methodological detailsbiomarker analysis, mediation analysis
- Biomarker analysis
- Mediation analysis
Primary result
As reported in the abstract
Rate of decline in FVC (mL) by baseline KL-6
KL-6 >1000 U/mL
−132.5
estimate · 95% CI −174.1–-91.0 · mL
KL-6 ≤1000 U/mL
−56.4
estimate · 95% CI −95.2–-17.6 · mL
P = 0.009
Further findings
Change in mRSS at week 52 by baseline biomarkers
- Higher baseline Pro-C3, CCL2 and CRP significantly associated with less improvement in mRSS (corrected for multiple comparisons)
Biomarker changes with nintedanib vs placebo · 52 weeks
- Decreases in CA-125 and pro-C6 with nintedanib vs placebo
Mediation of nintedanib effect on FVC change at week 52 by CA-125 decrease at week 24
- Proportion of effect attributed to treatment-related CA-125 decrease
- 48.0%
Original publication
Circulating biomarkers in patients with systemic sclerosis–associated interstitial lung disease in the SENSCIS trial. Ann Rheum Dis. Published 30 July 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →