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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.
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.
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.
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.
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.
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.
Research at UCL pioneered B cell depletion to treat rheumatoid arthritis (RA) and also stimulated the development of B-cell-directed therapies for other autoimmune rheumatic, haematological and neurological diseases. Now NICE approved, B cell depletion (based on rituximab) in RA is as effective as the alternative (anti-TNFα drugs) and an option for patients unable to gain benefit from anti-TNFα drugs. Rituximab offers drug-cost savings of up to £5,000/annum/patient and for many is a more convenient therapy, being given as an infusion only every five months apart, or more. B cell depletion has also proved to have an excellent safety profile, with many receiving repeated courses of treatment. As a consequence of UCL research, rituximab has brought substantial benefit to patients with many autoimmune diseases, including over 200,000 who have been treated with rituximab for RA so far.
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.
Jayne's team have co-ordinated a sequence of randomised clinical trials, that have defined the standard of care for ANCA vasculitis treatment and shaped national and international guideline statements, NHS national commissioning guidance and an on-going NICE assessment. Together with Ken Smith his group have pioneered the use of the B cell-depleting agent rituximab, in vasculitis, contributing key evidence that led to its licence approval (USA and EU) for this indication. Ken Smith's group supported by Jayne's clinical team have discovered novel therapeutic biomarkers, patented and being assessed in Phase II clinical studies, that promise to deliver "personalised medicine" in this and related conditions. These activities have harmonised the management of vasculitis, are improving patient outcomes, and have provided a resource for on-going scientific and clinical studies.
Dalgleish proposed a programme to develop thalidomide analogues for their immunomodulatory and anti-neoplastic actions. Working with a small start-up company, Celgene, several analogues including lenalidomide and pomalidomide were developed and entered clinical trials. Both drugs significantly prolong patient survival in myeloma and myelodysplasia and have received FDA and NICE approval for these purposes. Celgene has grown into a large multi-national company with over 5000 employees. Lenalidomide sales were $3.8 billion in 2012.