Boehringer Ingelheim International GmbH
- INGELHEIM, Germany|제약
INPULSIS®-ON study indicates safety and efficacy of Ofev® (nintedanib) are maintained over the long term and consistent with prior findings from INPULSIS® trials
Results from INPULSIS®-ON, the open-label extension from the two INPULSIS® Phase III trials, published in Lancet Respiratory Medicine
INGELHEIM, GERMANY--(Business Wire / Korea Newswire) September 17, 2018 -- Results from INPULSIS®-ON, published today in Lancet Respiratory Medicine, provide insights into the long-term safety, efficacy and tolerability of Ofev® (nintedanib) in patients with idiopathic pulmonary fibrosis (IPF). These data suggest that the effect of nintedanib on slowing disease progression of IPF persists beyond four years.1 Results also indicate that the long-term efficacy of nintedanib in reducing disease progression may be sustained in patients who require dose adjustments.
The exploratory findings of the open-label extension trial are consistent with results from the Phase III INPULSIS® trials and show that continued treatment with nintedanib, for up to 68 months, has a manageable safety and tolerability profile, with no new safety signals identified.[1,2,3,4] The INPULSIS®-ON trial featured a large cohort of patients with IPF who have received nintedanib, and these data add to the growing body of evidence suggesting that nintedanib provides long-term benefits to patients with IPF.[1,5]
IPF is a rare, debilitating and fatal lung disease that affects approximately  million people worldwide.[6,7,8] It causes progressive scarring of the lungs, resulting in continuous and irreversible deterioration in lung function and breathing difficulties. As IPF progresses, lung function gradually and irreversibly deteriorates.
In the INPULSIS®-ON trial, involving 734 patients:
· Descriptive efficacy assessments of lung function showed the annual rate of decline in forced vital capacity (FVC) over 192 weeks was -135.1 mL/year. This was consistent with the annual rate of FVC decline in patients treated with nintedanib in the INPULSIS® trials (-113.6 mL/year in patients treated with nintedanib).[1,3] Data from clinical trials suggest that FVC decline in placebo-treated patients with IPF and mild or moderate lung function impairment at baseline is approximately 200 mL over 1 year.
· The annual rate of decline in FVC was consistent irrespective of age, race and FVC % predicted at the start of INPULSIS®-ON.
· The incidence rate of acute exacerbations in INPULSIS®-ON was similar to that in patients treated with nintedanib in the INPULSIS® trials, further supporting the effect of nintedanib on reducing the risk of acute exacerbation[1,11]
· An acute exacerbation is a sudden deterioration in respiratory function, in many cases with unknown cause, which negatively impacts the disease course and often leads to death within a few months.[12,13,14]
The most common adverse event during INPULSIS®-ON was diarrhoea, as in the INPULSIS® and TOMORROW trials, and led to treatment discontinuation in 4.7% and 10.2% of patients who continued and initiated nintedanib during INPULSIS®-ON, respectively.[1,2,3,4,10] Cardiovascular (major adverse cardiac and vascular events, e.g heart attack or stroke) and bleeding exposure-adjusted event rates collected in patients who continued or initiated nintedanib in INPULSIS®-ON were similar to those observed in placebo-treated patients in the INPULSIS® trials.[1,2] These findings are also consistent with post-marketing surveillance data collected in the US during the first year following the launch of nintedanib as a treatment for IPF.
“The results of INPULSIS®-ON add to a growing body of evidence showing that nintedanib provides long-term benefits to patients with IPF,” said Professor Bruno Crestani, lead investigator of INPULSIS®-ON, Professor of Pneumology at the Paris Diderot University School of Medicine, France and Head of the Pneumology and Rare Lung Disease Department at Bichat Hospital, France. “IPF is a chronic disease that requires long-term treatment; therefore, long-term safety and efficacy data beyond four years of treatment is important. With these positive data from INPULSIS®-ON, physicians can feel confident that their patients can benefit from nintedanib over the long term.”
Dr Susanne Stowasser, Associate Head of Medicine Respiratory at Boehringer Ingelheim said: “The INPULSIS®-ON results provide valuable insights about the long-term safety and efficacy of OFEV® in IPF and supply further evidence of its positive impact on the lives of people living with this disease.” Dr Stowasser added: “Progressive fibrosing lung diseases like IPF continue to have a devastating impact on people’s lives and our focus remains on researching and bringing to market treatments that improve the lives of these patients at need.”
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