Combined evidence from the TOMORROW and INPULSIS clinical trials confirms the safety and efficacy of OFEV (nintedanib, Boehringer Ingelheim) in slowing disease progression and greatly reducing acute exacerbations in patients with idiopathic pulmonary fibrosis (IPF), a study reported.
The article detailing the pooled analyses of the clinical studies, “Nintedanib in patients with idiopathic pulmonary fibrosis: Combined evidence from the TOMORROW and INPULSIS® trials,” was published in the journal Respiratory Medicine.
The U.S. Food and Drug Administration (FDA) approved OFEV for the treatment of IPF in 2014. The approval was based on the results of a clinical trial program that included the Phase 2 TOMORROW trial and two Phase 3 INPULSIS trials, INPULSIS-1 and INPULSIS-2, which included in total 1,231 patients with IPF (723 treated with OFEV and 508 given a placebo). The results also led to the therapy’s approval in Europe and Japan.
Combined data from the three trials revealed that, overall, fewer people experienced acute exacerbations in the OFEV treatment group compared to the placebo group, 4.6% and 8.7%, respectively. OFEV was found to reduce the risk of an acute exacerbation by 47 percent compared to placebo, and also to improve forced vital capacity (FVC), another study endpoint.
Moreover, patients receiving OFEV had a 30 percent reduction in the risk of dying from any cause, a 43 percent reduced risk of on-treatment mortality, and a 38 percent reduction in the risk of dying from an acute exacerbation or any other respiratory cause. Importantly, the adjusted annual rate of FVC decline was significantly lower with OFEV than placebo treatment, or −112.4 mL/year and −223.3 mL/year, respectively.
“The analysis was consistent with individual study results showing that OFEV significantly reduces disease progression. It also shows a reduction in the risk of acute exacerbations and a trend to reduced mortality,” Danny McBryan, MD, vice president of Clinical Development and Medical Affairs, Respiratory, at Boehringer Ingelheim Pharmaceuticals, Inc., said in a press release. “As a company dedicated to respiratory care, we remain focused on continually uncovering new insights into IPF and OFEV to help support physicians as they have more informed treatment discussions with their patients.”
IPF is a type of interstitial lung disease, affecting the tissue that supports the alveoli in the lung. It is characterized by the inflammation or accumulation of scar tissue, known as fibrosis, in the lungs and leads to progressive loss of elasticity, failure of proper lung activity, and consequent poor oxygenation of the bloodstream and organs. There is no cure for IPF, and the fibrosis progress varies from patient to patient. Acute exacerbations, or a sudden and unpredictable worsening in respiratory function, are the leading cause of hospitalization in patients with IPF and constitute an important treatment goal in the management of the disease.