Researchers at the Royal National Hospital for Rheumatic Diseases (RNHRD) in Bath, part of the Royal United Hospitals Bath NHS Foundation Trust, are celebrating recruiting the first patient globally to an international study that is investigating a treatment that could save the NHS hundreds of millions of pounds a year and benefit patients worldwide.
The study is researching the introduction of a cheaper biosimilar medicine for inflammatory and autoimmune diseases such as rheumatoid arthritis and axial spondyloarthritis. If successful it will enhance the understanding of the use of biosimilars in clinical practice.
Biosimilar medicines are the clinical equivalent of a branded biologic or originator medicine, which are expensive and can cost the NHS several thousand pounds a year to treat a single patient. Biosimilars can be produced once the patent for the original biologic medication expires.
Dr Raj Sengupta, Consultant Rheumatologist leading the study at the RNHRD, said: “Recruiting the first global patient to this study is a huge achievement and a testament to all the hard work and collaborative efforts of our research and database team.
“Biosimilars are now well-stablished for use in patients with inflammatory arthritis. Randomised controlled trials have demonstrated excellent efficacy for patients who switch from the originator drug to the biosimilar. There are however very few studies that have looked at real world evidence – data collected during an observational study – to demonstrate the efficacy of these switches. We are very proud to participate in this global study looking at the effectiveness of switching axial spondyloarthritis and psoriatic arthritis patients from Humira, the originator medicine, to Imraldi, the biosimilar in a real world setting.”
The Pan-EU Real-World Experience with Imraldi: ‘PROPER’ Research Study is designed to recruit approximately 1,200 to 1,400 patients from 60-70 EU centres, across a range of immune-driven inflammatory diseases – Rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
PROPER is an observational study which follows the patient experience over 48 weeks after they have been switched from being treated with Humira to Imraldi.