RARE Daily

New Analysis Supports Long-Term Treatment with Ofev in SSc-ILD Patients

November 6, 2020

Rare Daily Staff

Boehringer Ingelheim reported results from an interim analysis of the SENSCIS-ON trial evaluating nintedanib in patients with systemic sclerosis-associated interstitial lung disease, which demonstrated long-term safety and suggested its sustained effect on slowing lung function decline.

Systemic sclerosis (SSc), also known as scleroderma, is a rare autoimmune disease characterized by thickening and scarring of connective tissue throughout the body. The disease is estimated to affect about 100,000 people in the United States and 2.5 million worldwide. Fibrosis, the hallmark of the disease, can affect the skin and internal organs, including the lungs. Interstitial lung disease (ILD), one of the most frequent disease manifestations, can be debilitating and may become life-threatening. Approximately 25 percent of patients develop significant lung involvement within three years of diagnosis and it is the leading cause of death among people with SSc.

Nintedanib is a tyrosine kinase inhibitor targeting key receptors involved in signaling pathways that lead to pulmonary fibrosis. It is already approved under the trade name Ofev in more than 80 countries for the treatment of patients living with idiopathic pulmonary fibrosis – a chronic and ultimately fatal disease characterized by a decline in lung function.

In September 2019, nintedanib was approved in the United States as the first and only therapy to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD and so far, regulatory approvals have been granted in more than 50 geographies including the European Union, Brazil, Canada, and Japan.

The SENSCIS-ON is an open-label extension trial to assess the long-term safety of nintedanib in patients with SSc-ILD who completed the phase 3 SENSCIS trial. The study is evaluating the absolute and relative change from baseline in the forced vital capacity (FVC) as a measure of lung function over 52 weeks.

The interim analysis showed that the safety profile of nintedanib in SENSCIS-ON was consistent with that reported over 52 weeks in the SENSCIS trial with diarrhea being the most frequently reported adverse event. The analysis showed that 347 patients in the extension study who received nintedanib demonstrated a decrease in FVC over 52 weeks as did patients in the SENSCIS study. The average change in FVC from baseline to week 52 of SENSCIS-ON was −51.3 mL in all patients treated in SENSCIS-ON, while the change from baseline to week 52 in the SENSCIS trial was −42.7 mL.

The new analysis was published online as part of ACR Convergence 2020.

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