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Thought leadership and innovation for the Pharmaceutical Industry

Chronic kidney disease (CKD) is an under-recognised condition thought to affect 700 million people worldwide. Too often the condition is diagnosed late and progresses to become severe enough to require dialysis or transplants.

 

AstraZeneca, a leader in the fight to tackle CKD, sees great opportunity to transform our understanding of who needs help and how to get it to them.

 

“CKD is a silent, progressive killer that is under diagnosed with hardly any cure,” says Joris Silon, Senior Vice President, Global Cardiovascular, Renal and Metabolism (CVRM), AstraZeneca. “In the US, it affects 15% of the population and at stage 3, where the kidneys are starting to decline rapidly, only 12% of cases are diagnosed.”

 

“Our ambition is to drive awareness and earlier diagnosis, to manage the progression of disease and halt that progression,” says Silon, “and at the same time, manage the life-threatening complications associated with that progression.”

 

New insights

AstraZeneca is taking a broad approach. Its DAPA-CKD trial of Farxiga (dapagliflozin) this year met all its primary and secondary endpoints for patients with chronic kidney disease, with and without type 2 diabetes. “We believe it will become the standard of care for patients that are at risk of developing CKD,” says Silon.

 

The company is also exploring root causes via the DISCOVER CKD study, an international observational study, comprising both prospective and retrospective patient cohorts. 

 

Running since September 2019 and due to conclude in 2023, the study of two million patients is also using smartphones and qualitative interviews to enable patients to share their own experiences about how the disease impacts their quality of life.

 

“The aim is to build a deeper understanding of the experiences of patients in the real world and ultimately to help them live longer and healthier lives,” says Silon. Empowering patients to share their experiences and encouraging and enhancing patient dialogue with HCPs in this way will help identify pain points and unmet needs among sufferers.

 

The DISCOVER CKD study is already revealing details about a highly co-morbid population with conditions including hypertension, heart failure, stroke and type-2 diabetes. It should also provide insights into preventative therapies such as intravenous iron or erythropoiesis-stimulating agents for non-dialysis dependent patients with anaemia, which is common but also under diagnosed in CKD sufferers.

 

Disease impact beyond the numbers

Beyond these studies, the company is also working with digital partners to explore the data in order to identify more people at an earlier stage. “We’ve been focusing on reframing the problem,” says Silon. “You could frame the problem to say ‘these people need medicines’, which we are still doing, but we are seeing that if you only do that, you are not improving patient outcomes. Patients don’t get treated if they don’t get diagnosed.”

 

Its collaboration with the RenalytixAI diagnostics platform aims to help identify patients at high risk. Given the high numbers of sufferers and stretched healthcare resources, parsing data on the patient population to identify those who would benefit the most from timely treatment or intervention is an obvious win, says Silon.

 

“Is there a patient group that is early in the disease but progressing faster than anyone else, who will go fastest to dialysis and will be most affected by the disease? We have learned that there are some biomarkers and learnings from electronic medical records to identify those patients at higher risk so that you can help move resources to them.”

 

This data-rich, technologically enhanced way to interact with patients will offer a far more holistic view of how CKD is affecting patients and the RenalytixAI venture will also identify patients to help with future trial recruitment.

 

AZ’s CKD Personal Impact Index, meanwhile, aims to better understand and measure the day-to-day impact of the disease and its complications beyond standard Quality of Life analyses. 

 

Giving a treatment for anaemia may still not be enough for patients to live a fulfilling life if they feel fatigued and are taking days out of work, for example. “We try to look at how the disease is impacting patients beyond the numbers, to measure the impact of the disease on the day-to-day life of patients and their families,” says Silon.

 

“We want to uncover the pain points that make a difference to them. Medicine is only part of it. There are so many other things that need to happen to improve patient experiences.”

 

Partnering with other players, such as digital experts, holds much promise for even further innovation here, such as the potential to help diagnose remotely via a smartphone. “There is an application in development enabling someone to take a photo of their urine at home and analysis shows whether they have CKD or not,” says Silon. “These home-based diagnostics are going to revolutionise healthcare.”

 

Clearly, there is great scope to drive innovation at speed. There is great need for it, too.

 

The urgency to find new solutions like these has increased in the pandemic, he adds. “Patients are not being diagnosed or are not as active in treating their disease as they were in the past. Monitoring, so we can care for them well and activate them better, should happen more at home than at the clinic.”

 

This new era in which medicine and digital therapeutics (DTx) increasingly go hand in hand is exciting but the research process and the regulatory process both need to adapt to encourage the development of medicines and DTx in tandem, says Silon.

 

“Patients are out there with massive needs, so we need to collaborate to make real changes for patients and the way they experience healthcare. We can’t wait five years until R&D has come up with the perfect solution. Today we have the opportunity to make a big difference for patients in embracing some of these tools."