Phase III study showed nintedanib slows the loss of pulmonary function in people living with systemic sclerosis associated ILD1

  • Results of pivotal Phase III SENSCIS® trial published today in the New England Journal of Medicine (NEJM) and presented at the American Thoracic Society Conference in Dallas, USA
  • Interstitial lung disease (ILD) is a key driver of mortality in people living with systemic sclerosis (SSc) – also known as scleroderma – and the absence of approved treatment options constitutes a high unmet need2,3
  • FDA grants priority review to application for regulatory approval for nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD)

INGELHEIM, Germany I May 20, 2019 I Boehringer Ingelheim today announced that the SENSCIS® trial met its primary endpoint: reduction in the annual rate of decline in forced vital capacity (FVCa) in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD). Results show that nintedanib slows the loss of pulmonary function in patients with SSc-ILD compared to placebo. Patients taking nintedanib showed a 44% reduction in the rate of decline of their lung function, measured in FVC assessed over 52 weeks1. These new data were today published in the New England Journal of Medicine (NEJM) and presented to the medical community at the American Thoracic Society (ATS) International Conference, in Dallas, USA.

SENSCIS® is the largest randomised controlled trial to be conducted in patients with SSc-ILD, a disease for which there are currently no approved treatments.1,3,4 Results also showed that nintedanib had a safety and tolerability profile similar to that observed in patients with idiopathic pulmonary fibrosis (IPF)1, with the most common adverse event being diarrhoea. Nintedanib is already approved in more than 70 countries for the treatment of IPF. These trial results formed the basis of the application for regulatory approval of nintedanib in SSc-ILD that was filed with the FDA and EMA by Boehringer Ingelheim in the first quarter of 2019. The FDA recently granted priority review to the supplemental application for nintedanib in SSc-ILD. The regulatory submissions are part of the company’s ongoing commitment to improving the lives of people living with pulmonary fibrosis, in particular those affected by rare diseases with a high level of unmet need.

Systemic sclerosis, also known as scleroderma, is a rare incurable autoimmune disease affecting connective tissue.3,4,5 It can cause scarring (fibrosis) of the skin as well as major organs such as the heart, lungs, digestive tract and kidneys and can have life-threatening complications.2,3 Approximately 25 percent of patients develop significant pulmonary involvement within three years of diagnosis.6 When SSc affects the lungs it can cause interstitial lung disease (ILD), known as SSc-ILD.2,3 It is a key driver of mortality among people with SSc, accounting for approximately one third of deaths.7,8

SENSCIS®, a Phase III double-blind, randomised, placebo-controlled trial, involved 576 patients across more than 32 countries. The primary endpoint was the annual rate of decline in FVC in mL over 52 weeks.1 At the end of the 52-week trial, patients receiving nintedanib had an adjusted annual rate of decline in FVC (mL/year) of -52.4 with nintedanib, versus -93.3 with placebo (absolute difference 41.0mL/year [95% CI 2.9, 79.0]; p=0.04). This corresponds to a relative difference of 44% reduction in lung function decline1, similar to the results from the Phase III INPULSIS® trials in IPF.12 FVC is an established measurement of lung function. As ILD progresses, lung function gradually and irreversibly deteriorates.9

“The SENSCIS results provide positive news for people living with SSc-ILD and their physicians because currently there are no approved treatments” explained Professor Oliver Distler, Professor of Rheumatology, University Hospital Zurich and lead investigator of the trial. “A 44% reduction in lung function decline indicates a significant slowdown in disease progression. Nintedanib could make a considerable difference to the lives of people with this rare and often life-threatening disease.”

“We are pleased to be able to share the positive results of the pivotal SENSCIS trial that are very consistent with the database from IPF and formed the basis of the recent submissions Boehringer Ingelheim made to the FDA and EMA for regulatory approval of nintedanib in February and March 2019”, said Dr. Susanne Stowasser, Associate Head of Medicine, Respiratory at Boehringer Ingelheim. “Fibrotic lung diseases including SSc-ILD continue to have a devastating impact on people’s lives and our focus remains on making treatments available to improve the lives of patients in areas of high unmet need.”

Notes to Editors

The SENSCIS® Trial
SENSCIS® was the largest randomised controlled trial to be conducted in patients with SSc-ILD, involving 576 patients across more than 32 countries including the United States, Canada, China, Japan, Germany, France and the United Kingdom. The primary endpoint was the annual rate of decline in lung function as measured in FVC (mL/year) assessed over 52 weeks.1 The trial also collected data on other manifestations of the disease with key secondary endpoints identified as skin thickness as measured by absolute changes from baseline in modified Rodnan skin score (mRSS) and health-related quality of life measured by the total score on the St George’s Respiratory Questionnaire (SGRQ) at week 52.1 Enrolment criteria included a diagnosis of SSc with onset of first non-Raynaud symptoms within 7 years, ILD confirmed by high resolution computed tomographic that showed fibrosis affecting at least 10% of the lungs, at least 40% predicted FVC, and a diffusion capacity of the lung for carbon monoxide (DLco) as 30–89% predicted.b,1 Patients were randomised to receive nintedanib 150 mg twice daily or placebo. Patients on stable therapy with mycophenolate or methotrexate and/or taking prednisone up to 10 mg/day were allowed to participate.1

Nintedanib
Nintedanib is already approved in more than 70 countries for the treatment of patients living with idiopathic pulmonary fibrosis (IPF) – a chronic and ultimately fatal disease characterised by a decline in lung function. Over 70,000 people with IPF have been treated with nintedanib.

Further background on systemic sclerosis
Systemic sclerosis is a rare disease with an estimated 15 to 24 people in every 100,000 in Europe living with the condition.10 Because scleroderma affects the connective tissue, symptoms can occur in any area of the body including the skin, muscles, blood vessels and internal organs, making it difficult to diagnose.2,3,11  The disease impacts four times as many women as men, and the onset of the disease typically occurs at a young age – between 25 and 55 years.11

Boehringer Ingelheim
Improving the health of humans and animals is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.

Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2018, Boehringer Ingelheim achieved net sales of around 17.5 billion euros. R&D expenditure of almost 3.2 billion euros, corresponded to 18.1 per cent of net sales.

As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

Intended audiences:
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

Footnotes

a FVC is Forced Vital Capacity, an established measure of lung function
b A measure of the extent to which oxygen passes from the air sacs of the lungs into the blood

References

1   Distler O, et al. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease. N Eng J Med. Published 20 May, 2019. NEJM.org. DOI: 10.1056/NEJMoa1903076
2   Solomon JJ, et al. European Respiratory Update: Scleroderma lung disease. Eur. Respir. Rev. 2013; 22: 127, 6–19.
3   Denton CP, Khanna D. Systemic sclerosis. www.thelancet.com (link is external) Published 13 April, 2017 http://dx.doi.org/10.1016/S0140-6736(17)30933-9 (link is external). Last accessed March 2019.
4   Cottin V, et al. Interstitial lung disease associated with systemic sclerosis (SSc-ILD). Respir. Res. 2019;20(1):13.
5   Kowal-Bielecka O, et al. Update of EULAR recommendations for the treatment of systemic sclerosis. Ann Rheum Dis. 2017;76(8):1327–39.
6   McNearney TA, et al. Pulmonary involvement in systemic sclerosis: associations with genetic, serologic, sociodemographic, and behavioural factors. Arthritis Rheum. 2007;57(2):318–326.
7   Tyndall AJ, et al. Causes and risk factors for death in systemic sclerosis: a study from the EULAR Scleroderma Trials and Research (EUSTAR) database. Ann Rheum Dis. 2010;69(10):1809–15.
8   Steen VD, et al. Changes in causes of death in systemic sclerosis, 1972-2002. Ann Rheum Dis. 2007;66(7):940–4.
9   Ley B, et al. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011;183:431–440.
10 Mayes MD. Scleroderma epidemiology. Rheum Dis Clin North Am. 2003;29(2):239–54.
11 Scleroderma Foundation. What is scleroderma? Available at: http://www.scleroderma.org/site/PageNavigator/patients_whatis.html#.V%20hgSaPlViko (link is external). Last accessed March 2019.
12 OFEV® Summary of Product Characteristics-October 2018. Boehringer Ingelheim International GmbH.

SOURCE: Boehringer Ingelheim

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