Data from phase III SENSCIS ON study of Ofev shows safety profile in systemic sclerosis-associated interstitial lung disease.- Boehringer

Boehringer announced results from an analysis of the SENSCIS-ON trial, an open-label extension trial of the Phase III SENSCIS study to assess the long-term tolerability and safety of Ofev (nintedanib) in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). The study also evaluated the change from baseline in forced vital capacity (FVC), a measure of lung function, over 52 weeks. In an analysis of SENSCIS-ON, the safety profile of Ofev in participants who continued therapy for an additional 52 weeks was consistent with that observed during the SENSCIS trial. Approximately two-thirds of patients continuing Ofev either maintained stable FVC (about 44%) or had an improvement in FVC (about 20%) based on FVC changes from baseline to week 52. This study provides evidence about the longer-term use of nintedanib in people living with SSc-ILD, and whether it can offer a sustained reduction in lung function decline with a manageable safety profile. These findings were published online in conjunction with the ATS 2021 International Conference.