Systemic sclerosis & Raynaud's

Quantitative HRCT as a surrogate outcome measure for nintedanib treatment in systemic sclerosis-interstitial lung disease and idiopathic pulmonary fibrosis

Joint Bone SpinePublished Prospective cohort study with historical untreated control cohort

Authors' conclusion

NIN appears effective in reducing the radiological decline of pulmonary fibrosis.

Study context

Population
Patients with SSc-associated progressive ILD and idiopathic pulmonary fibrosis
Participants
36 vs 36
Exposure
Nintedanib vs untreated historical cohort
  • NINn = 36
  • Untreatedn = 36reference
Outcome
Quantitative HRCT changes: percentage of normal parenchyma, ILD and vascular-related structures (CALIPER)
Follow-up
Mean 22 months
Methodological detailsprospective enrolment of treated patients, retrospectively selected historical untreated cohort comparable for disease, age, gender and follow-up period, quantitative HRCT (CALIPER software)
  • Prospective enrolment of treated patients
  • Retrospectively selected historical untreated cohort comparable for disease, age, gender and follow-up period
  • Quantitative HRCT (CALIPER software)

Main finding

As reported in the abstract

Quantitative HRCT change from baseline (% normal parenchyma and % ILD)
NIN: normal parenchyma from 81.3±11.8% to 78.6±15.6%
P=not significant
NIN: ILD from 14.5±10.4% to 16.7±14.2%
P=not significant
Untreated: normal parenchyma from 87.4±7.3% to 78.8±16.7%
P<0.001
Untreated: ILD from 9.0±5.9% to 16.5±14.8%
P<0.001

Observational data: associations, not effects.

Further findings

Vascular-related structures (VRS) · mean follow-up 22 months

VRS significantly increased regardless of antifibrotic therapy
P < 0.001

NIN-treated patients with clinically meaningful worsening of pulmonary function tests or reported dyspnoea (subgroup)

Significant loss of normal parenchyma in parallel with a greater increase in ILD
P < 0.05 for all

Original publication

Quantitative HRCT as a surrogate outcome measure for nintedanib treatment in systemic sclerosis-interstitial lung disease and idiopathic pulmonary fibrosis. Joint Bone Spine. Published 24 June 2025. doi:10.1016/j.jbspin.2025.105934

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