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Case study 1. Leeds Foot and Ankle Studies - introducing evidence-based podiatry for musculoskeletal services

Summary of the impact

Since 1998 the University of Leeds has developed the Leeds Foot and Ankle STudies in Rheumatology (FASTER) programme — to drive improvements in UK musculoskeletal foot care services. Results from FASTER clinical trials and a national survey of podiatry services directly informed NICE guidelines on foot care in arthritis. FASTER's research also provided key evidence for a national consensus on standards of care and aided a shift in the treatment paradigm for foot care in arthritis patients. These standards and NICE recommendations are included in the latest Royal College of GPs curriculum. They have also informed government policies on commissioning for podiatry services throughout England. Since the inception of the FASTER programme independent reports suggest that access to foot health services for people with rheumatoid arthritis has increased from less than 50% immediately prior to FASTER, to nearly 80% of patients today.

Submitting Institution

University of Leeds

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Political

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences

Threefold Increase in the Use of Anti-TNF in the Treatment of Common Chronic Inflammatory Conditions

Summary of the impact

Rheumatoid arthritis (RA) is a costly and debilitating autoimmune disorder that is characterized by joint pain, stiffness, and impaired functionality. Work at Imperial College identified tumour necrosis factor (TNF) as a key therapeutic target in the abnormal joint lining in RA. This discovery revolutionised the treatment of Rheumatoid Arthritis and other inflammatory conditions. Since 2008 the anti-TNF inhibitor infliximab (Remicade®) has been used to treat more than 1.3 million patients worldwide who have inflammatory conditions such as plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, adult and paediatric Crohn's disease, ulcerative colitis, and ankylosing spondylitis. The work has had ongoing impact across the globe for the treatment of inflammatory diseases. It established the concept of biological therapy demonstrating the use of an antibody to block a cytokine and treat chronic inflammatory disease. In 2012 Remicade® was the 4th best-selling worldwide drug with total global sales of $7.67 Billion.

Submitting Institution

Imperial College London

Unit of Assessment

Clinical Medicine

Summary Impact Type

Technological

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Immunology

UOA01-24: Revolutionising the Treatment of Rheumatoid Arthritis

Summary of the impact

Rheumatoid arthritis is a debilitating inflammatory condition, affecting around 500,000 people in the UK and around 0.5-1% of the adult population worldwide. Using novel techniques to study human synovium, Professor Sir Marc Feldmann and Professor Sir Ravinder Maini from the Kennedy Institute of Rheumatology identified a therapeutic target, TNFα, for treatment of rheumatoid arthritis. Following successful clinical trials, showing the safety and effectiveness of this new target, anti-TNFα antibodies have now become the gold standard treatment for severe rheumatoid arthritis worldwide. In addition to dramatically impacting patient care, anti-TNFα antibodies represent the largest group of therapies against rheumatoid arthritis on the market, with annual sales currently exceeding US$24.4 billion.

Submitting Institution

University of Oxford

Unit of Assessment

Clinical Medicine

Summary Impact Type

Economic

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Immunology

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

Reducing delays in accessing care for patients with a new onset of rheumatoid arthritis

Summary of the impact

Rheumatoid arthritis (RA) is a common destructive joint disease, causing pain and swelling, affecting 1 in 100 people. Work conducted by the University of Birmingham's Rheumatology Research Group has shown that early diagnosis is important, as the first few months represent a critical therapeutic window during which treatment can significantly improve health outcomes, increasing the chances of achieving disease remission and reducing the rate of progressive joint damage. The group have demonstrated that there are significant delays in patients making initial contact with their GP, which leads to delays in referral to a Rheumatologist and starting treatment; this situation has been shown to be worse in patients of South Asian origin. The outcome of the work has been incorporated into national policy documents and clinical guidance material and has underpinned a patient focused campaign to raise awareness of the disease and the need for early diagnosis.

Submitting Institution

University of Birmingham

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

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

Using intensive conventional drug treatment to optimise clinical outcomes in rheumatoid arthritis

Summary of the impact

An estimated 1% of UK adults suffer from rheumatoid arthritis and the long-term pain and disability associated with it, Historically, however, treatments focused on relieving symptoms and did not control the arthritis itself or prevent disability. An extensive series of clinical trials and associated research programmes at King's College London (KCL) over 20 years has now significantly improved treatment recommendations and thus quality of life for thousands of rheumatoid arthritis patients in the UK, Europe and other countries. Multicentre trials of intensive treatments using conventional drugs have extended the range of drugs available, established the effectiveness of early intensive treatment, and shown that early combination therapies are safe.

Submitting Institution

King's College London

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 6: Transforming the treatment of myeloma has produced significant improvement in patient survival: the MRC Myeloma trials

Summary of the impact

Two large multicentre clinical trials designed and led by researchers and clinicians in Leeds have resulted in major changes to treatment for patients with multiple myeloma. Myeloma VII clearly established the use of high-dose melphalan supported by autologous stem cell transplant (ASCT) following chemotherapy. Myeloma IX, the largest randomised controlled trial ever in myeloma, showed that zoledronic acid, in addition to reducing skeletal damage, showed an overall survival benefit and introduced the use of thalidomide as an effective yet less toxic therapy. Adoption of these treatment regimens has produced significantly improved outcomes throughout the developed 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, Oncology and Carcinogenesis

Novel treatment for psoriatic arthritis receives regulatory approval

Summary of the impact

Psoriatic arthritis (PsA) is a chronic inflammatory disease of joints, skin and tendons that affects 0.5-0.8% of the population worldwide. PsA can cause substantial psychological and social problems and also causes increased risk of death from cardiovascular disease. Research conducted by Prof Iain McInnes at the University of Glasgow in partnership with leading pharmaceutical company, Janssen, has provided robust evidence of the clinical benefits and safety of the cytokine blocker ustekinumab, leading to its approval for use for PsA by the European Medicines Agency in July 2013. This was the first approval of a PsA drug with a new mode of action in a decade, providing a novel treatment for approximately 1.25 million PsA patients across Europe.

Submitting Institution

University of Glasgow

Unit of Assessment

Clinical Medicine

Summary Impact Type

Technological

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Immunology

Tocilizumab – a new treatment for Rheumatoid Arthritis in adults and Juvenile Idiopathic Arthritis in children

Summary of the impact

Research at UCL into the use of tocilizumab has led to a new treatment and improved care for patients with juvenile idiopathic arthritis (JIA) and rheumatoid arthritis (RA) in adults. The drug is now approved around the world and recommended by NICE guidelines and is the standard of care in children with systemic onset JIA. It has been prescribed in every rheumatology centre in the UK for patients with severe RA. The impact of the drug on patients is to prevent disability, halt joint damage, improve function and increase quality of life.

Submitting Institution

University College London

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences

Improving treatment outcomes for patients with rheumatoid arthritis

Summary of the impact

When anti-TNF therapies (which block tumour necrosis factor) were first licensed in 1999 only a few hundred patients with rheumatoid arthritis had received them, most for relatively short periods of time. Although the drugs represented a major breakthrough, `real-world' effectiveness and safety were unproven. Research at the University of Manchester (UoM) has addressed this knowledge gap and has successfully refined the ways in which anti-TNF drugs are used around the world, leading directly to more effective prescribing and improved patient outcomes. The research has also provided strong evidence that women do not need to discontinue anti-TNF treatment prior to conception.

Submitting Institution

University of Manchester

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Immunology

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