First-in-human trial of a new drug for arthritis
Published on 08 February 2013
Arthritis Research UK researchers at King’s College have launched a first-in-human clinical trial of a low-cost therapy that uses the patient’s own immune system to fight rheumatoid arthritis.
A single infusion of binding immunoglobulin protein (BiP) could make a huge difference to people affected by rheumatoid arthritis (RA). Approximately 1,000 UK adults a year have to give up work because of the condition.
The first-in-human trial will run for two years, and is being carried out by researchers from King’s College London and clinicians from Guy’s and St Thomas’ NHS Foundation Trust. It is funded by Arthritis Research UK and supported by the NIHR Biomedical Research Centre at Guy's and St Thomas' and King's College London.
“This trial is the culmination of 15 years of work – it’s very exciting to be at this stage. Using patients’ own immune system to help protect against the disease is a new approach to treatment for rheumatoid arthritis,” says Dr Valerie Corrigall of King’s College London. “As well as being a very promising therapy, we’ve purposefully designed BiP to be more cost effective than biologic therapies which work well but are extremely expensive.”
Rebooting the immune system
BiP is part of the body’s normal anti-inflammatory response. Although it is found in the joints of people who have had RA for a long period it is in insufficient quantities to have a therapeutic effect.
Previous work by the team indicates that giving an intravenous dose of BiP will quickly boost the patients’ anti-inflammatory response. It will likely also ‘reset’ their immune system to give a long lasting effect.
“If BiP works as we expect then a single dose should be sufficient to put patients into remission for months,” says Professor Gabriel Panayi, professor emeritus of rheumatology at King’s College London, and honorary consultant rheumatologist at Guy’s and St Thomas’. “The most important thing is that our patients will have a better quality of life for longer. As a bonus, they should need fewer appointments which will free up valuable healthcare resources.”
Each year approximately 800,000 appointments are needed for existing patients, and about 80,000 for new patients.
Arthritis Research UK medical director Professor Alan Silman said: “We’re very excited that the culmination of several years of support has resulted in a potential new treatment for rheumatoid arthritis. This work is an example of where research funded by Arthritis Research UK has been translated into a possible new treatment that could come into clinical care within a reasonable time frame.”
A major health issue
Rheumatoid arthritis is the second most common form of arthritis in the UK, affecting around 400,000 adults, and is the commonest human autoimmune disease. It causes joint pain and swelling, stiffness, fatigue, and disability.
Although rheumatoid arthritis is more common in older people it also affects many people of working age, which has an impact on their personal finances and the wider UK economy. Up to 40 per cent of people with rheumatoid arthritis lose their jobs within five years because of their condition.
Potential treatment for osteoporosis?
Initial results show that BiP seems to inhibit osteoclasts (‘bone eating’ cells), making it a potential therapy for osteoporosis.
“It’s intriguing that BiP could help with another common disease, but more research is needed to establish this for certain,” says Professor Panayi.
About three million people in the UK have osteoporosis, and more than 230,000 fractures a year occur in the UK because of it. One in two women and one in five men over the age of 50 will have a fracture mainly as a result of the condition.