New Analysis Supports Long-Term Treatment with nintedanib in SSc-ILD Patients1

Ingelheim, Germany, Thu, 11/05/2020 - 16:00

Interim analysis demonstrated long-term safety and suggested a sustained effect of nintedanib on slowing lung function decline in patients with SSc-ILD¹
Safety and efficacy profile of nintedanib was consistent with the Phase III SENSCIS® trial, according to this analysis¹

Ingelheim, Germany, 5 November 2020 – Boehringer Ingelheim today announced results from an interim analysis of the SENSCIS®-ON trial evaluating nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). The new analysis was published online as part of ACR Convergence 2020.

SENSCIS-ON is an open-label extension trial to assess the long-term safety of nintedanib in patients with SSc-ILD who completed the Phase III SENSCIS® trial. The study is evaluating the absolute and relative change from baseline in the forced vital capacity (FVC) as a measure of lung function over 52 weeks.^1,2

The interim analysis showed that the safety profile of nintedanib in SENSCIS-ON was consistent with that reported over 52 weeks in the SENSCIS trial with diarrhea being the most frequently reported adverse event.¹The analysis showed that 347 patients in the extension study who received nintedanib demonstrated a decrease in FVC over 52 weeks as did patients in the SENSCIS study.¹ The average change in FVC from baseline to week 52 of SENSCIS-ON was −51.3 mL in all patients treated in SENSCIS-ON, while the change from baseline to week 52 in the SENSCIS trial was −42.7 mL.¹

“Boehringer Ingelheim is continuously committed to providing scientific data, offering clinicians more confidence in treating patients with SSc-ILD,” commented Dr. Susanne Stowasser, Associate Medical Head Pulmonology at Boehringer Ingelheim. “We are thrilled to share the new data demonstrating a similar consistent safety profile of nintedanib in people living with SSc-ILD and suggesting a sustained effect in slowing lung function decline.”

Notes to editors

About SSc-ILD
Systemic sclerosis, also known as scleroderma, is a rare autoimmune disease characterized by thickening and scarring of connective tissue throughout the body.³ The disease is estimated to affect about 100,000 people in the U.S. and 2.5 million worldwide.⁴Fibrosis, the hallmark of the disease, can affect the skin and internal organs, including the lungs.³ Interstitial lung disease (ILD), one of the most frequent disease manifestations, can be debilitating and may become life-threatening.³ Approximately 25 percent of patients develop significant lung involvement within three years of diagnosis⁵. ILD is the leading cause of death among people with SSc.⁶

Nintedanib
Nintedanib is a tyrosine kinase inhibitor targeting key receptors involved in signaling pathways that lead to pulmonary fibrosis.⁷ It is already approved in more than 80 countries for the treatment of patients living with idiopathic pulmonary fibrosis (IPF) – a chronic and ultimately fatal disease characterized by a decline in lung function. It is estimated that over 80,000 people with IPF have been treated with nintedanib, and it is recommended for use in IPF patients by international guidelines.⁸

In September 2019, nintedanib was approved in the U.S. as the first and only therapy to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD.⁹ Submissions have been made to other regulatory bodies across the globe and so far, regulatory approvals have been granted in more than 50 geographies including the European Union, Brazil, Canada and Japan.¹⁰

Nintedanib has now been approved for the treatment of other chronic fibrosing interstitial lung diseases with a progressive phenotype in over 40 geographies.¹¹

Boehringer Ingelheim
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of 19 billion euros. Our significant investment of almost 3.5 billion euros in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

More information about Boehringer Ingelheim can be found at 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.

References

1 Allanore Y, Vonk M, Azuma A, Mayes M, Gahlemann M, James A, Kohlbrenner V, Stowasser S, Highland K. Continued Treatment with Nintedanib in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Interim Analysis of SENSCIS-ON [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10).
2 A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03313180. Last accessed: November 2020
3 Cottin V, Hirani NA, Hotchkin DL, et al. Presentation, diagnosis and clinical course of the spectrum of progressive-fibrosing interstitial lung diseases. Eur Respir Rev 2018;27(150):pii:180076.
4 Scleroderma. www.rheumatology.org. Published March 2017. Accessed October 30, 2020. https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Scleroderma
5 McNearney TA, Reveille JD, Fischbach M, et al. Pulmonary involvement in systemic sclerosis: associations with genetic, serologic, sociodemographic, and behavioral factors. Arthritis Rheum. 2007;57(2):318-326. doi:10.1002/art.22532
6 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 Oct;69(10):1809-15. doi: 10.1136/ard.2009.114264.
7 European Summary of Product Characteristics Ofev®, July 13, 2020. Data on file.
8 Raghu G, et al. An Official ATS/ERS/JRS/ALAT Clinical Practice Guidelines: Treatment of Idiopathic Pulmonary Fibrosis: Executive Summary. Am J Respir Crit Care Med. 2015; 192(2)238 – 248.
9 U.S. Food and Drug Administration news release. FDA approves first treatment for patients with rare type of lung disease. Available at https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-rare-type-lung-disease. Last accessed June 2020.
10 Data on file
11 Data on file