MedicalResearch.com Interview with:
Donald Zoz, M.D.,
Senior associate director
Clinical Development & Medical Affairs
Boehringer Ingelheim Pharmaceuticals, Inc.
MedicalResearch.com: What is the background for this study? How does nintedanib differ from other treatments for SSc-ILD? What are the main findings?
Response: SENSCIS is a Phase III double-blind, randomized placebo-controlled trial that included 576 patients in 32 countries. It is the largest trial to have been conducted in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD). The primary endpoint was the annual rate of decline in forced vital capacity (FVC) over 52 weeks. At the end of the 52-week trial, patients receiving nintedanib had an adjusted annual rate of decline in FVC (mL/year) of -52.4 with nintedanib versus -93.3 with placebo (absolute difference 41.0mL/year [95% CI 2.9, 79.0]; p=0.04). This corresponds to a relative difference of 44% reduction in lung function decline.
There are currently no approved treatments for SSc-ILD., BI conducted the SENSCIS study to evaluate in SSc-ILD patients the impact of nintedanib. Nintedanib, a selective tyrosine kinase inhibitor, is an antifibrotic agent.
Results of the study, which were published in The New England Journal of Medicine and presented at the American Thoracic Society (ATS) International Conference, showed that nintedanib slowed the loss of pulmonary function by 44% in patients with SSc-ILD relative to placebo, as measured by FVC over 52 weeks.
MedicalResearch.com: What should readers take away from your report?
Response: This is an important study because interstitial lung disease (ILD), is a devastating and often fatal consequence of systemic sclerosis (SSc). Approximately 25 percent of SSc patients develop significant pulmonary involvement within three years of diagnosis. Lung involvement is the leading cause of death among people with systemic sclerosis.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: BI will be conducting further analysis of the SENSCIS results and will be present these findings at future medical conferences. Our goal is to further the understanding and research advancements that address this high unmet need among patients living with this complicated rare disease. In addition, Boehringer Ingelheim initiated the SENSCIS-ON study, an open-label extension to follow patients in the original trial and collect long-term data.
MedicalResearch.com: Is there anything else you would like to add?
Response: The trial results form the basis of the application for regulatory approval of nintedanib in SSc-ILD, which was filed with the FDA and EMA at the beginning of this year. The FDA recently granted priority review to this supplemental application. The SENCSIS trial was funded by Boehringer Ingelheim.
Nintedanib for Systemic Sclerosis–Associated Interstitial Lung Disease
Oliver Distler, M.D., Kristin B. Highland, M.D., Martina Gahlemann, M.D.,
Arata Azuma, M.D., Aryeh Fischer, M.D., Maureen D. Mayes, M.D.,
Ganesh Raghu, M.D., Wiebke Sauter, Ph.D., Mannaig Girard, M.Sc.,
Margarida Alves, M.D., Emmanuelle Clerisme-Beaty, M.D., Susanne Stowasser, M.D.,
et al., for the SENSCIS Trial Investigators*
May 20, 2019
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