• Chronic kidney disease is one of the most severe secondary complications related to diabetes[1]
• Study demonstrates new predictive model based on real-world data to offer enhanced accuracy compared to traditional methods in prognosing the risk of this diabetes-related long-term complication
• The research, published in Nature Medicine, was the result of a collaboration between Roche, IBM Watson Health, and partners[2]

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced promising results from a new study which supports the use of real-world data, including electronic medical record data, to predict the risk of chronic kidney disease (CKD) in individuals with diabetes. The study, published in the journal Nature Medicine [https://rdcu.be/bfKPU], showed that the newly developed predictive model based on real-word data was more accurate than previously published predictive algorithms with a baseline at 0.7937 (95% confidence interval [CI] 0.790, 0.797).[3]

Chronic kidney disease is one of the most severe diabetes-related complications, which is why the research team first targeted this medically, socially, and economically important application.[4] It is characterized by the progressive loss of the kidney function, beginning with a decline in the glomerular filtration rate and/or albuminuria, eventually resulting in end-stage renal disease. Experts estimate approximately 10% of people with diabetes to be affected by this complication within three years following the initial diabetes diagnosis. This severe complication often requires dialysis or renal transplant therapy. Early recognition of the CKD risk followed by the appropriate interventions can slow down the progression or, possibly, even prevent the onset of this diabetes-related complication. The researchers from Roche and IBM used real-world clinical data originating from more than 600,000 people with type 1 and type 2 diabetes to develop a new predictive model to help identify the risks for developing CKD within the first three years after the initial diabetes diagnosis. [5]

While conventional diagnostic procedures, therapeutic recommendations, and medical risk assessments are frequently based on clinical trial data, a plethora of real-world medical data exists in clinics and medical doctors’ offices which could potentially help evaluate patient’s risk level and tailor the most appropriate treatment. The accuracy of the new predictive model developed by Roche and IBM was compared with certain clinical trial data and showed to be better than the traditional methods of estimating the risk of newly diagnosed patients developing chronic kidney disease..5 

 “Our research team from Roche and IBM successfully invented this novel predictive model to identify those people with diabetes who are at a high risk of developing CKD in the near future,” says Wolfgang Petrich, Ph.D., Research Lead at Roche Diabetes Care, Mannheim, Germany. “

A direct comparison between this new predictive model and already existing, similar models, which were solely derived from clinical trial data, revealed that the model developed by our team outperformed tested methods in a one-to-one comparison on real world data as well as for study cohorts selected a posteriori.”  

“This study demonstrates the growing importance of real-world data and predictive analytics in diabetes care,” said Dr. Mark Davies, Chief Medical Officer (EMEA), IBM. “There is a growing need to improve screening performance and the decision-making processes in diabetes care, and this new data suggest that real-world data and analytics can be applied to help in early recognition of risk of CKD.”

A follow-up evaluation was performed in co-operation between Roche and the Indiana Biosciences Research Institute (IBRI), the Regenstrief Institute, and Eli Lilly and Company. This evaluation was able to confirm all prior findings, when applying the new model to independent real-world data originating from almost 100,000 additional people with diabetes. Although additional research is suggested by the research team, the initial results indicate that real-world data-based predictive models may provide an efficient tool for improved, personalised healthcare aiding clinical decision making, while offering the potential for a timely mitigation of the impact and severity of diabetes-related complications.

About Roche Diabetes Care

Roche Diabetes Care is pioneering innovative diabetes technologies and services for more than 40 years. Being a global leader in integrated diabetes management, more than 5,000 employees in over 100 markets worldwide work every day to support people with diabetes and those at risk to achieve more time in their target range and experience true relief from the daily therapy routines. Roche Diabetes Care collaborates with caregivers, healthcare providers and payers to optimally manage this complex condition and contribute to sustainable care structures. Under the brand Accu-Chek and in collaboration with partners, Roche Diabetes Care creates value by providing integrated solutions to monitor glucose levels, deliver insulin and track as well as contextualize relevant data points for a successful therapy. By establishing a leading open ecosystem, connecting devices and digital solutions, Roche Diabetes Care will enable optimal personalised diabetes management and thus improve therapy outcomes. Since 2017, mySugr with its world-leading mobile diabetes management app and services is part of Roche Diabetes Care. For more information, please visit www.accu-chek.com and www.mysugr.com.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in-vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

For more information please contact:

- Ute Volkmann ([email protected])

- Soo-Jin Pak ([email protected])

All trademarks used or mentioned in this release are protected by law.

[1],3,4 Diabetes and Chronic Kidney Disease (2016). Retrieved from https://www.kidney.org/news/newsroom/factsheets/Diabetes-And-CKD.

[2] Eli Lilly, Indiana Biosciences Research Institute, Regenstrief Institute

[3],5 S. Ravizza et al. Predicting the risk of early chronic kidney disease in diabetes patients using real world data. Nature Medicine (Nature Medicine | VOL 25 | JANUARY 2019 | 57–59); full text access: https://rdcu.be/bfKPU