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Boehringer Ingelheim: New study results provide evidence that Ofev® slows progression of IPF beyond four years with consistent safety
- INPULSIS®-ON study indicates safety and efficacy of Ofev®(nintedanib) are maintained over the long term and consistent with prior findings from INPULSIS® trials1
- Results from INPULSIS®-ON, the open-label extension from the two INPULSIS® Phase III trials, published in Lancet Respiratory Medicine1
Results from INPULSIS®-ON, published 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 exacerbation1,11
- 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.”
1Crestani B, Huggins JT, Kaye M, Costabel U, Glaspole I, Ogura T, Song JW, Stansen W, Quaresma M, Stowasser S, Kreuter M. Long-term treatment with nintedanib in patients with idiopathic pulmonary fibrosis: results from INPULSIS-ON. Lancet Respir Med. 2018 https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(18)30339-4/fulltext
2 OFEV® Summary of Product Characteristics-July 2017. Boehringer Ingelheim International GmbH.
3 Richeldi L, et al. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Eng J Med. 2014;370:2071–2082.
4 Corte T, et al. Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis. Respir Res. 2015;16:116.
5 Crestani B, et al. Long-term nintedanib treatment in idiopathic pulmonary fibrosis (IPF): new data from INPULSIS-ON. Eur Respir J. 2017 50: OA3402; DOI: 10.1183/1393003.congress-2017.OA3402.
6 Ley B, et al. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011;183:431–440.
7 Nalysnyk L, et al. Incidence and prevalence of idiopathic pulmonary fibrosis: review of the literature. Eur Respir Rev. 2012;21:355–361.
8 Data on file. Boehringer Ingelheim. Worldwide prevalence 2016.
9 NHLBI, NIH. What Is Idiopathic Pulmonary Fibrosis? Accessed at: www.nhlbi.nih.gov/health/health-topics/topics/ipf/ Accessed August 2018.
10 Kolb M, et al. Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume. Thorax. 2016. doi:l0.1136/thoraxjnl-2016-208710.
11 Richeldi L, et al. Nintedanib in patients with idiopathic pulmonary fibrosis: combined evidence from the TOMORROW and INPULSIS® trials. Respir Med. 2016;113:74–79.
12 Kim DS. Acute exacerbations in patients with idiopathic pulmonary fibrosis. Respir Res. 2013;14:86.
13 Song JW, et al. Acute exacerbation of idiopathic pulmonary fibrosis: incidence, risk factors and outcome. Eur Respir J. 2011;37:356-363.
14 Collard H, et al. Acute Exacerbations of Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2007;176:636–643.
15 Lancaster LH, et al. Safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis (IPF): pooled data from six clinical trials. Presented at American Thoracic Society Conference 2018. San Diago, CA. United States, May 18–23, 2018.