Boehringer Ingelheim reported results from the phase 3 SENSCIS trial in which treatment with Ofev (nintedanib) led to a reduction in the annual rate of decline in forced vital capacity (FVC) in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD). These new data were also published the New England Journal of Medicine (NEJM) and presented to the medical community at the American Thoracic Society (ATS) International Conference in Dallas.
SENSCIS was a double-blind, randomized, placebo-controlled trial and enrolled 576 patients across more than 32 countries. Enrollment criteria included a diagnosis of SSc with onset of first non-Raynaud symptoms within 7 years, ILD confirmed by high resolution computed tomographic that showed fibrosis affecting at least 10% of the lungs, at least 40% predicted FVC, and a diffusion capacity of the lung for carbon monoxide (DLco) as 30–89% predicted.b,1 Patients were randomized to receive nintedanib 150 mg twice daily or placebo. The primary endpoint was the annual rate of decline in lung function as measured in FVC (mL/year) assessed 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. This corresponds to a relative difference of 44% reduction in lung function decline. Total adverse events were similar in both groups. A higher incidence of diarrhea, the most common side effect, was reported in the nintedanib group (75.7%) versus the placebo group (31.6%).
Results from this study 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 for nintedanib in SSc-ILD.
The FDA approved Ofev in 2014 for the treatment of idiopathic pulmonary fibrosis.
About Systemic Sclerosis and Associated Interstitial Lung Disease
Systemic scleroderma is an autoimmune disorder that affects the skin and internal organs. Autoimmune disorders occur when the immune system malfunctions and attacks the body’s own tissues and organs. The word “scleroderma” means hard skin in Greek, and the condition is characterized by the buildup of scar tissue (fibrosis) in the skin and other organs. The condition is also called systemic sclerosis because the fibrosis can affect organs other than the skin, including the lungs, resulting in interstitial lung disease.
About Ofev (nintedanib)
Ofev (nintedanib) is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these receptors and blocks the intracellular signaling which is crucial for the proliferation, migration, and transformation of fibroblasts representing essential mechanisms of the IPF pathology.