BOEHRINGER-INGELHEIM

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

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