Nintedanib slows the loss of pulmonary function in people living with systemic sclerosis associated interstitial lung disease
For UK and Republic of Ireland medical and pharmaceutical trade media
For immediate use 20 May 2019
Nintedanib slows the loss of pulmonary function in people living with systemic sclerosis associated interstitial lung disease1
- SENSCIS® trial met its primary endpoint of reduction in the annual rate of decline in forced vital capacity in patients with systemic sclerosis associated interstitial lung disease1
- Results of pivotal Phase III SENSCIS® trial published today in the New England Journal of Medicine and presented at the American Thoracic Society Conference in Dallas, USA1
- Interstitial lung disease is a key driver of mortality in people living with systemic sclerosis – 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
Bracknell, UK, 20 May 2019 – Boehringer Ingelheim today announced that the SENSCIS® (Safety and Efficacy of Nintedanib in Systemic SClerosIS) trial met its primary endpoint of reduction in the annual rate of decline in forced vital capacity (FVC, an established measure of lung function) 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.1 Patients taking nintedanib showed a 44% reduction in the rate of decline of their lung function, measured in FVC assessed over 52 weeks.1 These new data were published today in the New England Journal of Medicine (NEJM) and presented at the American Thoracic Society (ATS) International Conference, in Dallas, USA.
Professor Toby Maher, Professor of Interstitial Lung Disease, National Heart and Lung Institute, Imperial College, London, and SENSCIS Steering Committee Member said: “Today’s findings are extremely important, particularly given that there are currently no approved treatments for this condition, which disproportionately affects women, and especially those between 25 and 55 years old. A 44% reduction in lung function decline represents a significant slowdown in the development of irreversible fibrosis of the lung. Nintedanib has the potential to make a big difference to the lives of people with this rare, life-shortening disease.”
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 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.1 Nintedanib is already approved in more than 70 countries for the treatment of IPF.
Dr Juliet Roberts, Medical Director, UK & Ireland, Boehringer Ingelheim said “Clinical trials should always address an important scientific question with patient needs as a priority. We are proud that this trial not only contributes to the evidence base in an area of clear unmet medical need, but was also designed with the support and input of scleroderma patient organisations from many countries.”
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 March 2019. The FDA recently granted priority review 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.2,5,6 When scleroderma affects the lungs it can cause interstitial lung disease (ILD), known as SSc-ILD.2,5 It is a key driver of mortality among people with scleroderma, accounting for approximately one-third of deaths.7,8 Approximately 8 in 10 patients with scleroderma develop ILD, with up to 30% developing a progressive and serious form that may require treatment.5
SENSCIS®, a Phase III double-blind, randomised, placebo-controlled trial, involved 576 patients across 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 decline,1 similar to the relative effect of nintedanib versus placebo on reducing the rate of decline in FVC in the Phase III INPULSIS® trials in IPF (relative reduction 49%).1 FVC is an established measurement of lung function. As ILD progresses, lung function gradually deteriorates.
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 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 and at least 40% predicted FVC, and a diffusion capacity of the lung for carbon monoxide (DLco) as 30–89% predicted (a measure of the extent to which oxygen passes from the air sacs of the lungs into the blood).1 Patients were randomised to receive nintedanib 150 mg twice daily or placebo. Patients on stable therapy with mycophenolate mofetil or methotrexate and/or taking prednisolone up to 10 mg/day were allowed to participate.1
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.
Improving the health and quality of life of patients is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The company 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 2017, Boehringer Ingelheim achieved net sales of nearly 18.1 billion euros. R&D expenditure, exceeding three billion euros, corresponded to 17.0 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.
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- Distler O, et al. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease. NEJM. May 16 2019; 380(20).
- Solomon JJ, et al. European Respiratory Update: Scleroderma lung disease. Eur. Respir. Rev. 2013; 22: 127, 6–19.
- Cottin V, et al. Interstitial lung disease associated with systemic sclerosis (SSc-ILD). Respir. Res. 2019;20(1):13.
- Kowal-Bielecka O, et al. Update of EULAR recommendations for the treatment of systemic sclerosis. Ann Rheum Dis. 2017 Aug;76(8):1327-1339.
- Denton CP, Khanna D. Systemic sclerosis. Lancet. 2017; 390(10103): 1685-99.
- National Institute for Health and Care Excellence. Proposed Health Technology Appraisal. Nintedanib for treating interstitial lung disease caused by systemic sclerosis.
- 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.
- Steen VD, et al. Changes in causes of death in systemic sclerosis, 1972-2002. Ann Rheum Dis 2007;66(7):940–4.
- Ley B, et al. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011;183:431–440.
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Date of preparation: May 2019