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Case Study 10. Improving lives and transforming services for Paroxysmal Nocturnal Haemoglobinuria (PNH), a life-threatening, disabling blood disorder

Summary of the impact

Eculizumab has transformed quality of life and life expectancy for patients with PNH and led to major economic impacts with global drug sales of $1,134 million in 2012 and to Alexion Pharmaceuticals being worth over $19 billion. PNH is a disabling blood disorder that was previously fatal in 50% of patients but with eculizumab survival is comparable to the normal population as well as returning patients to having a normal quality of life. Research in Leeds led to the introduction of eculizumab in 2007. Eculizumab is now approved for clinical use in over 40 countries and for another life threatening disease, atypical haemolytic uraemic syndrome.

Submitting Institution

University of Leeds

Unit of Assessment

Clinical Medicine

Summary Impact Type

Technological

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Neurosciences, Public Health and Health Services

Case Study 7. Changing the treatment paradigm of rheumatoid arthritis: early diagnosis and aggressive treatment to attain remission leads to sustained improvements in health and quality of life

Summary of the impact

Research in Leeds led by Professor Paul Emery pioneered early diagnosis and treatment for patients with rheumatoid arthritis (RA), with the aim of disease remission rather than reduction of symptoms. This approach has transformed management of RA and is now standard practice for patients worldwide. It has led to greatly improved disease control, increased quality of life and reduced disability as well as direct productivity gains of an estimated £4 million per year to the UK economy.

Submitting Institution

University of Leeds

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences

Case Study 4. Improving chemotherapy, radiotherapy and patient outcomes for colorectal cancer through patient-focused integrated clinical trials

Summary of the impact

Colorectal cancer is a common disease, which frequently causes death or morbidity, either because of failure to control the primary tumour or failure to prevent distant metastases. Leeds researchers have devised new treatment approaches using chemotherapy and radiotherapy and tested them in large randomised controlled trials which have led to major changes in clinical practice in the management of rectal cancer and advanced colorectal cancer (aCRC), driving clinical decision-making and improving outcomes for patients. This includes better-evidenced treatment for elderly patients and patient stratification on the basis of molecular biomarkers.

Submitting Institution

University of Leeds

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Oncology and Carcinogenesis

Setting the standard in lymphoma therapy

Summary of the impact

Research conducted by a multidisciplinary team of oncologists and scientists at the University of Southampton has driven major advances in lymphoma care, leading to the development and standardisation of effective new antibody treatments and optimal drug regimens. Through their direction of international clinical trials, they have influenced care for Hodgkin and Burkitt lymphoma in the UK and internationally, affecting all stages of patient-experience from diagnosis to treatment. Their findings underpin significant improvements in survival and quality of life for the 14,000 people affected by lymphoma in the UK each year.

Submitting Institution

University of Southampton

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Oncology and Carcinogenesis

Establishment of tacrolimus as the first choice calcineurin inhibitor for the immunosuppression regimen in liver transplant recipients

Summary of the impact

Research at UCL firmly established tacrolimus as the optimal calcineurin inhibitor to use in immunosuppressive regimens following liver transplantation. Compared to ciclosporin its use improved graft survival by 6% and patient survival by 7%. Assuming 550 liver transplants per year in the UK since 2008, we can estimate that, with 90% of patients treated with tacrolimus and 10% ciclosporin, tacrolimus-based immunosuppression has resulted in 165 grafts and 192 lives being saved during the period 2008-13.

Submitting Institution

University College London

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Immunology

Systemic therapies for ovarian cancer

Summary of the impact

University of Glasgow research has led to the adoption of first-line chemotherapy for ovarian cancer, which has improved patient survival by 11% and has been used to treat 66% of women with ovarian cancer since January 2011 in the West of Scotland Cancer Care Network alone. These therapies are recommended by guidelines for ovarian cancer treatment in the USA, Europe and the UK. The USA guidelines are disseminated to 4.3 million people worldwide and the European guidelines reach 15,000 health professionals. The UK guidelines are used to identify those drugs that are funded by the NHS and used in NHS hospitals.

Submitting Institution

University of Glasgow

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Oncology and Carcinogenesis

Case Study 2: Clinical trials show that the novel cytotoxic drug eribulin prolongs survival in women with heavily pre-treated metastatic breast cancer

Summary of the impact

Clinical trials designed and led by Professor Chris Twelves (University of Leeds) showed eribulin to be the first single agent cytotoxic to prolong survival in women with heavily pre-treated metastatic breast cancer (MBC).

Eribulin has been approved by European, U.S. and other regulatory authorities since 2010. Cancer treatment guidelines in the U.S., Europe and elsewhere now recommend eribulin. Sales of eribulin generated many millions of pounds in the first full year following approval. Already tens of thousands of women have been treated with eribulin, who collectively have gained up to ten thousand added life years. The U.S. regulatory authorities have advocated the EMBRACE trial design for future trials.

Submitting Institution

University of Leeds

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Oncology and Carcinogenesis, Public Health and Health Services

Reducing the toxicity of pemetrexed treatment in malignant pleural mesothelioma.

Summary of the impact

Malignant pleural mesothelioma (MPM) is a treatable but incurable cancer that originates in the cells lining the lungs. Over 14,000 people worldwide are diagnosed annually with MPM. Antifolates are often used in cancer therapy, but side effects are a major issue. A retrospective analysis of cancer trials and phase 1 trial of MPM patients, carried out by Newcastle in collaboration with Eli Lilly Pharmaceuticals, determined that plasma homocysteine levels were a good predictor of drug toxicity in cancer patients treated with the antifolate pemetrexed, and that this drug was well tolerated by patients with low homocysteine levels. It was also determined that pemetrexed treatment should be supplemented with vitamin B12 as well as folic acid, to reduce drug toxicity. Ultimately, this permitted the continued development of pemetrexed, which otherwise would have been too toxic for clinical use. It is now the only licensed drug for MPM treatment in combination with platinum-based chemotherapy.

Submitting Institution

Newcastle University

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Public Health and Health Services

Case Study 1. The Acute Infarct Ramipril Efficacy Study: a simple treatment to improve survival after acute myocardial infarction

Summary of the impact

The Acute Infarct Ramipril Efficacy (AIRE) multicentre international trial, conceived, designed, led and coordinated by Leeds was the first to show that use of early angiotensin converting enzyme Inhibitor (ACEI) therapy in patients with signs and symptoms of heart failure after an acute myocardial infarction (AMI) is associated with significantly longer survival and better quality of life. Further Leeds research showed the beneficial effects persisted long-term. The strategy of early initiation of ACEI is now a fundamental and routine part of the management of patients after AMI and has contributed to better survival and quality of life for patients around the world.

Submitting Institution

University of Leeds

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Clinical Sciences, Public Health and Health Services

Case Study 9. Changing cancer services and improving patient outcomes in the UK

Summary of the impact

Research in Leeds showed, conclusively for the first time, improved outcomes for cancer patients managed in multidisciplinary specialised cancer care teams. Our research and systemic overview provided the evidence for a new government policy to reconfigure cancer care services into Cancer Networks, Centres and Units. This required radical evidence-based changes including centralisation of many cancer surgical services. A rigorous implementation plan based on research evidence, was initiated under Leeds leadership and sustained in subsequent government policies. It changed clinical guidelines and professional standards, altered practice for all UK cancer patients and contributed to improved cancer survival.

Submitting Institution

University of Leeds

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Oncology and Carcinogenesis, Public Health and Health Services

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