Ofev (nintedanib) reduced the annual rate of FVC decline in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD), according to SENSCIS data presented at ATS 2019 by Boehringer Ingelheim.
Results showed that Ofev slowed the loss of pulmonary function by 44% in patients with SSc-ILD relative to placebo, as measured by FVC over 52 weeks. These new data were published today in the New England Journal of Medicine (NEJM) and presented at ATS 2019 in Dallas.
SENSCIS is the largest randomized controlled trial to be conducted in patients with SSc-ILD, a disease for which there are currently no approved treatments. Results demonstrated that nintedanib was generally well-tolerated with the most common side effect being diarrhea. The safety and tolerability profile in SSc-ILD patients was similar to that previously observed in idiopathic pulmonary fibrosis (IPF) patients treated with nintedanib.
“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,” said study investigator Kristin Highland, MD, pulmonologist with the Cleveland Clinic.
Results from this study form 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 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. Nintedanib, marketed as Ofev, is already approved in more than 70 countries for the treatment of IPF.
“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, Ph.D., executive director, Clinical Development and Medical Affairs, Specialty Care, Boehringer Ingelheim. “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.”
SENSCIS, a Phase III double-blind, randomized, 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. FVC is an established measurement of lung function. As ILD progresses, lung function gradually and irreversibly deteriorates.
There was no difference between groups for secondary endpoints, skin thickness and quality of life, as measured at week 52 by the modified Rodnan Skin Score (mRSS) and the St. George’s Respiratory Questionnaire (SGRQ), respectively.
In the study, the percentage of 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%).