Last patient recruited in the SENSCIS™ trial
Investigating nintedanib treatment in people with interstitial lung disease related to systemic sclerosis (SSc-ILD).
The importance of the SENSCIS™ trial
All of the 520 required patients in the SENSCIS™ trial have now been recruited.1 This important Phase III trial is investigating the use of nintedanib in people with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Systemic sclerosis (SSc) is a serious disease of unknown cause.2 Aside from the skin, lungs are most often involved but the disease may also show as abnormalities in blood vessels, kidneys, heart, gastrointestinal system, and muscles.2 Next to pulmonary arterial hypertension, interstitial lung disease is the leading cause of death related to SSc.3 There are currently no approved treatments available for this life-threatening condition.
The SENSCIS™ trial (Safety and Efficacy of Nintedanib in Systemic SClerosIS) is another example of our ongoing commitment to improving the lives of patients living with rare diseases.
The largest global clinical trial in SSc-ILD
The burden of systemic sclerosis (scleroderma)
Systemic sclerosis is a disfiguring, disabling and potentially fatal rare disease that causes scarring (fibrosis) of the skin and major organs such as the lungs. Systemic sclerosis may also affect blood vessels, kidneys, gastrointestinal system, heart and muscles.2,3 It mostly affects women aged between 25 and 55 years.2
Interstitial lung disease (ILD) is a common manifestation of SSc characterised by the development of varying degrees of fibrosis in the lungs and is one of the leading causes of death related to SSc.3
For people affected by SSc-ILD, the condition affects their daily life in a number of ways; lung fibrosis affects their breathing, movement and energy levels. These symptoms often make it hard for patients to continue working as before and many find it difficult to walk long distances. Modifying the course of systemic sclerosis-associated ILD is the aspiration behind the development of new treatments.
The physician’s perspective on systemic sclerosis
“I’ve been looking after systemic sclerosis patients now for more than 25 years. I think that we’re starting to make an impact on some of the life-threatening complications. I think it’s been very positive to see that treatments are starting to emerge that are more effective for the skin disease and potentially for the lung fibrosis. So my hope is that this will be translated into real, long-term clinical benefit for patients.”
Professor Chris Denton, Consultant Rheumatologist, Royal Free Hospital, London, UK.
Nintedanib in other fibrosing conditions
Nintedanib is already approved for the treatment of patients living with idiopathic pulmonary fibrosis (IPF) – a chronic and ultimately fatal disease characterised by a decline in lung function. Nintedanib has been shown to slow disease progression in IPF patients. Building on this positive real-world clinical experience, we are exploring whether nintedanib’s proven anti-fibrotic properties can generally target scarring conditions in other diseases like systemic sclerosis or other non-IPF progressive interstitial lung diseases.
Boehringer Ingelheim in respiratory disease
For over a century, we have been committed to improving the lives of people living with respiratory diseases. Completion of patient recruitment in the SENSCIS™ trial is an exciting and important step in this disease area where high unmet needs exist.
Ivan Blanarik, Therapeutic Area Head Respiratory
Footnotes
1 Clinical trial.gov. A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis. Available at: https://clinicaltrials.gov/ct2/show/NCT02597933. Last accessed January 2018.
2 Scleroderma Foundation. What is scleroderma? Available at: www.scleroderma.org/site/PageNavigator/patients_whatis.html#.V hgSaPlViko. Last accessed January 2018
3 Solomon JJ, Olson A L, Fischer A, et al. European Respiratory Update: Scleroderma lung disease. Eur.Respir. Rev. 2013; 22: 127, 6–19.
OFEV Summary of Product Characteristics. Boehringer lngelheim International GmbH. July 2017.