New data in rare disease published showing nintedanib slows the loss of pulmonary function in people living with systemic sclerosis associated interstitial lung disease.
Boehringer Ingelheim has announced that the SENSCIS® (Safety and Efficacy of Nintedanib in Systemic SClerosIS) trial met its primary endpoint of reduction in the annual rate of decline in forced vital capacity (FVC, an established measure of lung function) in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD).
Results show that nintedanib slows the loss of pulmonary function in patients with SSc-ILD compared to placebo. Patients taking nintedanib showed a 44% reduction in the rate of decline of their lung function, measured in FVC assessed over 52 weeks. These new data were published in the New England Journal of Medicine (NEJM) and presented at the American Thoracic Society (ATS) International Conference, in Dallas, USA.
SENSCIS® is the largest randomised controlled trial to be conducted in patients with SSc-ILD, a disease for which there are currently no approved treatments. Results also showed that nintedanib had a safety and tolerability profile similar to that observed in patients with idiopathic pulmonary fibrosis (IPF), with the most common adverse event being diarrhoea. Nintedanib is already approved in more than 70 countries for the treatment of IPF.
These trial results formed the basis of the application for regulatory approval of nintedanib in SSc-ILD that was filed with the FDA and EMA by Boehringer Ingelheim in March 2019. The FDA recently granted priority review for nintedanib in SSc-ILD. The regulatory submissions are part of the company’s ongoing commitment to improving the lives of people living with pulmonary fibrosis, in particular those affected by rare diseases with a high level of unmet need.
Systemic sclerosis, also known as scleroderma, is a rare incurable autoimmune disease affecting connective tissue. It can cause scarring (fibrosis) of the skin as well as major organs such as the heart, lungs, digestive tract and kidneys, and can have life-threatening complications. When scleroderma affects the lungs it can cause interstitial lung disease (ILD), known as SSc-ILD. It is a key driver of mortality among people with scleroderma, accounting for approximately one-third of deaths. Approximately 8 in 10 patients with scleroderma develop ILD, with up to 30% developing a progressive and serious form that may require treatment.
SENSCIS®, a Phase III double-blind, randomised, placebo-controlled trial, involved 576 patients across 32 countries. The primary endpoint was the annual rate of decline in FVC in mL 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, similar to the relative effect of nintedanib versus placebo on reducing the rate of decline in FVC in the Phase III INPULSIS® trials in IPF (relative reduction 49%).1 FVC is an established measurement of lung function. As ILD progresses, lung function gradually deteriorates.