Effect of nintedanib in patients with systemic sclerosis- associated interstitial lung disease and risk factors for rapid decline in forced vital capacity: further analyses of the SENSCIS trial*

Background In the SENSCIS ** trial with systemic sclerosis-associated interstitial lung disease (SSc-ILD) patients, with a mean time since first non-Raynaud symptom of 3.5 years and 52% with diffuse cutaneous SSc (dcSSc), nintedanib reduced the FVC decline (mL/year) over 52 weeks by 44% versus placebo. Risk factors for a rapid decline in FVC in patients with SSc include early SSc, elevated inflammatory markers, significant skin involvement, and dcSSc. SSc patients with risk factors for rapid ILD progression are typically given immunosuppressants but not nintedanib. We analyzed the FVC decline and the effect of nintedanib on FVC decline in subjects with these risk factors in the SENSCIS trial.