New Study Indicates Significant Survival Increase for Liver Transplant Patients with Advagraf
Results of a large observational study published in the American Journal of Transplantation (AJT) has demonstrated that early and sustained use of Advagraf, a once-daily immunosuppressant, offers a significant graft survival benefit in liver transplant patients over twice-daily tacrolimus (tacrolimus BID or immediate release). Tacrolimus is currently the standard of care for the prevention of organ rejection in liver transplantation.
The results of the study showed a significant graft survival benefit of 8% at 3 years (p=0.01) in liver transplant patients on Advagraf versus tacrolimus immediate release. The study, a retrospective analysis, was conducted by the European Liver Transplant Registry (ELTR), one of the largest and most robust independent registries, that holds data for 98% of liver transplants conducted in Europe.
Whereas for a large number of diseases, such as cancer and diabetes, the standardised mortality rate is falling, for liver disease, mortality rates have been increasing over the past few decades. In addition, more than 500 patients are on the UK’s active liver transplant list (as of March 2014), which is a 12% increase since 2013 and 880 transplants have taken place between 2013 and 2014 in the UK. It is also estimated that over the past 20 years, the number of potential patients in the UK who could benefit from a liver transplant has increased by 90%, whilst the number of available donations has remained the same.
Both Advagraf and tacrolimus immediate release are immunosuppressants licensed for the prevention of organ rejection in patients receiving Liver and Kidney transplants. Due to its distinctive pharmacokinetic profile, Advagraf offers patients a more convenient reduced pill intake, as it permits once daily administration, over tacrolimus immediate release which is twice daily.
Dr Varuna Aluvihare, Consultant Hepatologist, King’s College, London said: “A graft survival benefit means better patient survival, meaning that for every 13 patients treated with Advagraf, we could potentially save 1 life when compared to people being treated with the usual twice daily tacrolimus. Whilst we do not know the underlying reason for this benefit, it is exciting to speculate that this may due to some benefits inherent in this formulation of tacrolimus, as well as the undoubted fact that patients find it easier to take.”
Andrew Langford from the British Liver Trust said: “We know that, compared to other major diseases, liver disease mortality is increasing at an alarming rate over the past 30 years and is the UK’s third commonest cause of premature death. Although liver transplant is a life saver for some, it is concerning that around a quarter of patients will still die within five years of their transplant.”
“Therefore, the data we are seeing from the ELTR’s real-world study are very significant and an increase in graft survival has important implications for patient survival. In addition, reducing from twice daily to once daily has a positive impact on a person’s quality of life.”
Dr Alan McDougall, Medical Director, Astellas Pharma Ltd UK said: “Astellas are dedicated to delivering innovative and high quality treatments to patients. These real-world data suggest that the once daily formulation of Advagraf, when compared to twice daily immediate release tacrolimus, has the potential to benefit hundreds of liver transplant patients in the UK.”
The benefit was still seen when the propensity score matching (population number n=810) for baseline characteristics was applied and Advagraf continued to demonstrate an observed 8% reduction in graft loss at 3 years vs. tacrolimus immediate release.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance