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 and presented to the medical community at the American Thoracic Society 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 1, 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 the first quarter of 2019.
The FDA recently granted priority review to the supplemental application 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.
Approximately 25% of patients develop significant pulmonary involvement within three years of diagnosis.
When SSc affects the lungs it can cause interstitial lung disease, known as SSc-ILD.
It is a key driver of mortality among people with SSc, accounting for approximately one third of deaths.
SENSCIS, a Phase III double-blind, randomised, placebo-controlled trial, involved 576 patients across more than 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 results from the Phase III INPULSIS trials in IPF.12 FVC is an established measurement of lung function. As ILD progresses, lung function gradually and irreversibly deteriorates.
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