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IIn a new long-term study, nintedanib (Ofev) improved forced vital capacity (FVC) and other idiopathic pulmonary fibrosis (IPF) symptoms. The findings were presented recently at the American Thoracic Society (ATS) 2015 International Conference in Denver.
In a new long-term study, nintedanib (Ofev) improved forced vital capacity (FVC) and other idiopathic pulmonary fibrosis (IPF) symptoms. The findings were presented recently at the American Thoracic Society (ATS) 2015 International Conference in Denver.
In the phase 2 TOMORROW trial, the average observed change in decline in FVC – the amount of air that can be exhaled after maximum inhalation (a measure of IPF disease progression) – was consistently lower in the nintedanib 150-mg twice-a-day group than in the comparator group (-3.1% vs. -6.3% from baseline to week 76).
In addition, a lower proportion of patients in the nintedanib 150-mg twice-a-day group versus the comparator group had at least 1 acute IPF exacerbation (a sudden and severe worsening of IPF) (4.7% vs. 19.5% of patients). The safety and tolerability of nintedanib was similar between periods 1 and 2.
“As IPF is a life-threatening and progressive disease, patients will be on life-long treatment to manage their disease. It is important to assess and continue to monitor the efficacy and safety of Ofev in these patients,” said Bruno Crestani, professor of pneumology and deputy dean for research at the Paris Diderot University School of Medicine, France. “These data strengthen the evidence supporting the efficacy, safety and tolerability of Ofev and further our understanding of treating this complex disease.”
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Following the placebo-controlled 52-week treatment phase of the trial (period 1), patients were given the option to continue blinded treatment (period 2) until the last patients had finalized the 52-week treatment period. In a post-hoc analysis of the trials, nintedanib showed a consistent effect on reducing the annual rate of FVC decline, whether or not patients had varying degrees of lung function impairment. Patients with early disease benefited in a similar way from treatment with nintedanib compared to patients with more advanced disease.
The results highlight the importance of early detection and timely treatment of patients with IPF, according to Martin Kolb, director of the Division of Respiratory, Department of Medicine, McMaster University, Canada. “In addition, the data presented at the conference includes a wide range of patient types, which are representative of patients seen in clinical practice.”