According to a story from Boehringer Ingelheim Pharmaceuticals, Inc., the company has recently announced positive results from a phase 3 clinical trial testing the company’s drug nintedanib (marketed as Ofev) as a treatment for interstitial lung disease associated with systemic sclerosis. The study found that Ofev was capable of reducing the rate of lung function decline in patients. Ofev is currently approved as a treatment for idiopathic pulmonary fibrosis and, when combined with other therapies, non-small cell lung cancer.
About Systemic Sclerosis/Scleroderma
Scleroderma, which is also referred to as systemic sclerosis, describes a group of autoimmune diseases that can cause system-wide effects in the most severe cases. The mechanism of this disease is believed to be an autoimmune response in which the immune system mistakenly attacks body tissue. Some factors that may contribute to triggering the autoimmune response include mutations of the HLA genes and exposure to certain materials, such as certain solvents, white spirits, ketones, and silica. Symptoms are broad ranging and systemic, including kidney failure, erectile dysfunction, fatigue, stroke, headaches, facial pain, congestive heart failure, skin abnormalities, high blood pressure, chest pain, indigestion, and many more. Treatments are varied and depend on the symptoms, but most patients take medications in an attempt to suppress the autoimmune response. In severe cases, life expectancy is around 11 years from onset. To learn more about scleroderma, click here.
Trial Results
The phase 3 trial was international in scope and included patients from 32 different countries. 576 patients were included in the trial. The results from the study showed that Ofev was able to slow down the decline of lung function by 44 percent during a 52 week period. This is similar to the results of the drug in trials for idiopathic pulmonary fibrosis.
These findings are good news for patients affected by systemic sclerosis. While the ten year survival rate for the disease is around 70 percent, interstitial lung disease can be a major contributor to mortality and declining quality of life for these patients. The findings suggest that Ofev can help slow the progression of lung disease in systemic sclerosis.
These results will strengthen the company’s application for approval in this indication that was filed to the FDA earlier in 2019.
