The results of a Phase IIa clinical trial have suggested a potential new antibody treatment for patients suffering from Sjögren’s syndrome. The trial was sponsored by Novartis and run in conjunction with the NIHR Translation Research Collaboration (TRC) in joint and inflammatory diseases.
It is thought that up to 500,000 people in the UK, mainly women, suffer from Sjögren’s syndrome, which is caused when the body’s immune system attacks glands that secrete fluid, such as tears and saliva.
In some cases parts of the body outside the glands can also be affected, resulting in pain and swelling of the joints, skin rashes or shortness of breath for example. It is the second most common autoimmune condition after rheumatoid arthritis, yet it remains underappreciated and under treated with generally, only symptomatic relief such as artificial tears available.
The double-blind, placebo-controlled randomised trial tested an antibody, CFZ533, in patients with severe primary Sjögren’s syndrome. The antibody blocks CD40, which is a co-stimulatory pathway receptor that is essential in immune mediated functions in Sjögren’s syndrome. Significant improvements were seen in patients who received CFZ533 and the treatment was safe and well tolerated after 24 weeks of administration.
Dr Benjamin Fisher, Senior Lecturer in Rheumatology within the University of Birmingham’s Institute of Inflammation and Ageing and a researcher within the inflammatory arthritis theme in the NIHR Birmingham Biomedical Research Centre, presented the results at the recent American College of Rheumatology Annual meeting.
“Patients with Sjögren’s syndrome have been a relatively neglected population and yet their quality of life can be greatly affected,” explained Dr Fisher. “No drugs have been proven to systemically alter the abnormal immune activity underlying it, so these early findings are very exciting.”
Birmingham is one of the 12 centre members of the NIHR TRC in joint and inflammatory diseases. TRCs are ready-formed partnerships of leading universities and NHS hospitals set up to work with the life sciences industry. They carry out translational research and tackle experimental medicine challenges in selected therapeutic areas.
“If this is repeated in a much larger study, we have potentially found a way to alter the effects of Sjögren’s on patients,” concluded Dr Fisher.