New Treatment Option for Systemic Sclerosis-Associated Interstitial Lung Disease

The U.S. Food and Drug Administration has approved nintedanib (Ofev, Boehringer Ingelheim Pharmaceuticals) capsules to slow the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD), which is a progressive lung disease that can be debilitating and life-threatening.

Nintedanib, an intracellular tyrosine kinase inhibitor, is the first and only approved treatment for SSc-ILD.

“Interstitial lung disease is the leading cause of death among people with scleroderma, typically resulting from a loss of pulmonary function that occurs when the lungs cannot supply enough oxygen to the heart. Approximately 100,000 individuals in the United States have scleroderma, and approximately half of scleroderma patients have SSc-ILD,” the FDA wrote.

The FDA approval was backed by data from the randomized, double-blind, placebo-controlled SENSCIS trial, which included 576 patients aged 20-79 years with SSc-ILD. Patients received either 150mg of twice-daily, orally-administered nintedanib or a placebo. Forced vital capacity decline rates were followed for 52 weeks.

Results showed that the percentage of patients with more than 10-percent relative forced vital capacity decline after 52 weeks was 16.7 percent and 18.1 percent for participants receiving nintedanib and placebo, respectively. The respective relative effect of nintedanib compared with placebo in reducing the rate of force vital capacity decline was 44 percent versus 49 percent. Researchers noted that nintedanib showed no other clinical benefit and no affect of health-related quality of life.

The most frequent serious adverse event reported in patients treated with nintedanib was pneumonia, occurring in 2.8 percent of patients versus 0.3 percent with placebo. Adverse reactions leading to permanent dose reductions were reported in 34 percent and 4 percent of patients, receptively. While adverse events occurred at similar rates in each group, they caused more nintedanib recipients to discontinue treatment. Diarrhea was the most common adverse event affecting 75.7 percent and 31.6 percent of nintedanib and placebo recipients, respectively.

Nintedanib is also approved for use in adults with idiopathic pulmonary fibrosis.

See full prescribing information here.Source: FDA news release.