Objective To assess microvascular changes in nailfold capillaries in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) who received nintedanib or placebo in a sub-study of the SENSCIS trial. Methods Nailfold capillaroscopy (NC) was performed at baseline and week 52. In the nintedanib and placebo groups, we measured capillary density (number of capillaries/mm), giant capillaries, abnormal shapes and percentage of fingers with microhaemorrhages. In addition, capillary density was evaluated in patients who did/did not have risk factors for rapid forced vital capacity (FVC) decline at baseline and who did/did not have ILD progression (absolute decline in FVC % predicted >5% or death) from baseline to week 52. Results Between baseline and week 52, no notable changes were observed in any NC measurement in the overall placebo or nintedanib groups. In patients with risk factors for rapid FVC decline (n=38), there was a numerical reduction in mean capillary density over 52 weeks with placebo, but it remained stable with nintedanib. Among patients who had ILD progression (n=11), there was a numerical increase in mean capillary density over 52 weeks with nintedanib, but it remained stable with placebo. There were no notable changes in capillary density among patients who did not have risk factors for rapid FVC decline at baseline or ILD progression at week 52. Conclusion In a substudy of the SENSCIS trial, numerical differences in changes in capillary density assessed by NC over 52 weeks may suggest a potential effect of nintedanib in patients at risk of ILD progression.
Smith et al. (Wed,) studied this question.