Interim analysis demonstrated long-term safety and suggested a sustained effect of nintedanib on slowing lung function decline in patients with SSc-ILD1
Safety and efficacy profile of nintedanib was consistent with the Phase III SENSCIS trial, according to this analysis1
INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim today announced results from an interim analysis of the SENSCIS®-ON trial evaluating nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). The new analysis was published online as part of ACR Convergence 2020.
SENSCIS-ON is an open-label extension trial to assess the long-term safety of nintedanib in patients with SSc-ILD who completed the Phase III SENSCIS® trial. The study is evaluating the absolute and relative change from baseline in the forced vital capacity (FVC) as a measure of lung function over 52 weeks.1,2
The interim analysis showed that the safety profile of nintedanib in SENSCIS-ON was consistent with that reported over 52 weeks in the SENSCIS trial with diarrhea being the most frequently reported adverse event.1 The analysis showed that 347 patients in the extension study who received nintedanib demonstrated a decrease in FVC over 52 weeks as did patients in the SENSCIS study.1 The average change in FVC from baseline to week 52 of SENSCIS-ON was −51.3 mL in all patients treated in SENSCIS-ON, while the change from baseline to week 52 in the SENSCIS trial was −42.7 mL.1
“Boehringer Ingelheim is continuously committed to providing scientific data, offering clinicians more confidence in treating patients with SSc-ILD,” commented Dr. Susanne Stowasser, Associate Medical Head Pulmonology at Boehringer Ingelheim. “We are thrilled to share the new data demonstrating a similar consistent safety profile of nintedanib in people living with SSc-ILD and suggesting a sustained effect in slowing lung function decline.”
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Please click on the link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/newanalysisnintedanibsscild