The Phase 3 SENSCIS trial reached its primary endpoint by showing that Ofev (nintedanib) slows the decay in forced vital capacity (FVC) — a measure of lung function — in people with systemic sclerosis (SSc)-associated interstitial lung disease (SSc-ILD).
The results of the trial were published in the article “Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease,” in the New England Journal of Medicine (NEJM), and data also were presented at the American Thoracic Society (ATS) International Conference in Dallas, held May 17-22.
SSc is characterized by the appearance of scarring tissue (fibrosis) in different organs, including the lungs. ILD is a known key driver of mortality among SSc patients, and there is no approved treatment for SSc-ILD.
Ofev, marketed by Boehringer Ingelheim, is a treatment that blocks a set of growth factors associated with the progression of pulmonary fibrosis, a chronic and progressive ILD. Ofev is an approved treatment for idiopathic pulmonary fibrosis in more than 70 countries, including the U.S.
The double-blind, randomized, placebo-controlled SENSCIS trial (NCT02597933) was designed to evaluate the safety and efficacy of Ofev in people with SSc-ILD. In total, 576 patients were recruited in more than 32 countries. Half the patients received Ofev during a year (52 weeks), while the other half received a placebo.
Results showed that Ofev treatment slowed the decline in FVC by 44%, when compared with the placebo, over the course of the study. The secondary endpoints of skin thickness and quality of life were similar between both groups.
“The results of the SENSCIS trial showed that nintedanib [Ofev] has a beneficial effect by reducing the rate of decline in FVC in patients with ILD associated with systemic sclerosis over a 1-year period. In this trial, no other clinical benefit was observed” for other symptoms of systemic sclerosis, the researchers said.
“These study results are welcome news for doctors and their patients because lung fibrosis, which results in shortness of breath and persistent coughing, is a devastating and often fatal consequence of systemic sclerosis,” Kristin Highland, MD, study investigator and pulmonologist with the Cleveland Clinic, said in a press release.
The treatment was overall well-tolerated, with over 80% of the patients finishing the 52-week trial. The most common side effect, diarrhea, was more prevalent in the treatment group. This safety profile is similar to the one observed in people with idiopathic pulmonary fibrosis treated with Ofev.
Based on the results of the SENSCIS trial, Boehringer Ingelheim recently applied to the U.S. Food Drug Administration (FDA) and the European Medicines Agency (EMA) for regulatory approval for the use of Ofev in treating patients with SSc-ILD. The FDA granted the application priority review.
“The study provides positive evidence that nintedanib significantly slows the progression of lung function decline for those living with systemic sclerosis who are diagnosed with interstitial lung disease,” said Thomas Leonard, PhD, executive director of clinical development and medical affairs, specialty care, at Boehringer.
“Boehringer Ingelheim is pleased that the FDA has recognized the urgency to bring a new treatment to patients by designating the application as a priority review,” Leonard added.
The company is performing an open-label extension study (NCT03313180) to evaluate the long-term effects of Ofev in people with SSc-ILD.