- Phase III study established equivalence in efficacy and similar safety profile between BI 695501 and Humira® (adalimumab) in patients with active rheumatoid arthritis (RA)
- Results pave the way for submitting BI 695501 for regulatory approval in key markets
INGELHEIM, Germany I October 26, 2016 I Boehringer Ingelheim today announced top-line results from the pivotal Phase III clinical study of BI 695501, a biosimilar candidate to U.S.-licensed Humira® and EU approved Humira® (adalimumab). BI 695501 met the clinical study primary efficacy endpoint to establish equivalence with Humira® in patients with active rheumatoid arthritis (RA). The secondary endpoints for efficacy, safety and immunogenicity of BI 695501 vs. Humira®, were also met.
“This milestone paves the way for submitting BI 695501 for regulatory approval in key markets such as the USA and Europe”, said Sandeep Athalye, MD, Vice President and Head, Clinical Development and Medical Affairs Biosimilars, Boehringer Ingelheim. ”With our focus on BI 695501 and other biosimilar candidates, we recognize biosimilars as playing an increasing role in providing patients and doctors with high quality therapeutic options while contributing to the long term sustainability of healthcare systems.”
This Phase III clinical study was a randomized, double-blind, parallel arm, multiple dose, active comparator study1 in 645 patients diagnosed with moderate to severe active rheumatoid arthritis who were treated with methotrexate. Each participant was randomized to receive either BI 695501 or Humira® every two weeks for 48 weeks. The primary objective of this clinical study was to establish statistical equivalence in efficacy between BI 695501 and Humira® in patients with active RA as measured by the proportion of patients meeting ACR20 (American College of Rheumatology 20) criteria at Week 12 and at Week 24 compared to baseline.2
The secondary objectives of this clinical study were to compare other efficacy parameters (DAS28)3, safety and immunogenicity of BI 695501 and Humira®.
Results from this clinical study will be published and presented at future medical congresses.
About Boehringer Ingelheim in Biologics and Biosimilars
Boehringer Ingelheim is one of the largest producers of biologic medicines in the world. As a pioneer in biologics with more than 35 years of experience, the company has manufactured more than 25 biologic medicines for global markets.iv This includes monoclonal antibodies in oncology and immunology, interferons, and other targeted medicines that are routinely used to treat many patients across a broad range of therapeutic areas. Boehringer Ingelheim further builds on its commitment to oncology and immunology to develop biosimilars as high quality, safe, and effective treatment options to patients with cancer and autoimmune diseases.
Boehringer Ingelheim currently has two biosimilar monoclonal antibodies in late stage clinical development: BI 695501, adalimumab biosimilar candidate to Humira® and BI 695502, bevacizumab biosimilar candidate to Avastin®*. All public information on our clinical trials is available on: http://clinicaltrials.gov/ (link is external)
About Rheumatoid Arthritis
Rheumatoid Arthritis (RA) is a chronic inflammatory autoimmune disease affecting synovial joint lining; causing pain, stiffness, swelling and limited motion and function of joints.v In many patients, the progressive destruction of joints may ultimately result in disability. Three times as many women are affected by RA compared to men. RA affects approximately 23.7 million people worldwidevi and 1.6 million people in the United States.vii,viii It can develop at any time during adulthood, but it usually occurs between 40 and 70 years of age.ix
Boehringer Ingelheim
Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally through 145 affiliates and a total of some 47,500 employees. The focus of the family-owned company, founded in 1885, is on researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects through, for example, the initiative “Making More Health” while also caring for employees. Respect, equal opportunity and reconciling career and family form the foundation of mutual cooperation. The company also focuses on environmental protection and sustainability in everything it does.
In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of net sales.
For more information please visit www.boehringer-ingelheim.com
References
i BI695501 compared to adalimumab in patients with active rheumatoid arthritis. Clincialtrials.gov web site. Available at: https://clinicaltrials.gov/ct2/show/NCT02137226?term=695501&rank=2. Accessed September 2016.
ii ACR20 is a globally accepted composite measure of comparing response to treatment in Rheumatoid Arthritis clinical trials. A 55% ACR20 response means 55% of patients in the study achieved a 20% improvement in tender or swollen joint counts as well as 20% improvement in three of the other five criteria used in assessment of disease.
iii DAS28 (Disease Activity Score 28) is a composite system developed and validated by the EULAR (European League Against Rheumatism) to measure the progress and improvement of Rheumatoid Arthritis. It is represented as a number on a scale from 0 to 10 representing disease activity.
iv Boehringer Ingelheim. (January 2015). Producing Value: Global Contract Manufacturing Excellence [Brochure].
v Medline Plus, “Rheumatoid Arthritis” Accessed 11 October 2011. Available at http://www.nlm.nih.gov/medlineplus/ency/article/000431.htm
vi World Health Organization, “The Global Burden of Disease, 2004 Update.” Accessed 04.08 August 2016. Available at http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf?ua=1
vii Sacks, J., Lou, Y., Helmick, C. Prevalence of Specific Types of Arthritis and Other Rheumatic Conditions in the Ambulatory Health Care System in the United States 2001-2005. Arthritis Care and Research. 2010. 62(4): 460- 464.
viii Howden, L., Meyer, J., 2010 U.S. Census Bureau results — U.S. Census Bureau, 2010 Census Summary File.
ix Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001; 358:903-911.
SOURCE: Boehringer Ingelheim
