BOEHRINGER-INGELHEIM

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).¹ 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.¹

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 3 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.⁹ As IPF progresses, lung function gradually and irreversibly deteriorates.⁶

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.¹⁰
• The annual rate of decline in FVC was consistent irrespective of age, race and FVC % predicted at the start of INPULSIS^® -ON.¹
• 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.¹⁵

“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.”

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/press-release/inpulsis-shows-ofev-slows-progression-ipf

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