Tuesday, 16 August 2016
Bioelectronic device improves rheumatoid arthritis symptoms in first-in-human trial
A trio of collaborators announced Monday clinical trial data showing that an implantable neuromodulation device improved symptoms of rheumatoid arthritis. The results may also have an impact on patients with other inflammatory diseases, such as Parkinson’s, Alzheimer’s and Crohn’s disease.
The Feinstein Institute, Academic Medical Center/University of Amsterdam and GSK-backed bioelectronics player SetPoint Medical announced the results, which were published in Proceedings of the National Academy of Sciences. It is the first study to examine the effect of stimulating the inflammatory reflex in humans. It involved 17 patients with active rheumatoid arthritis (RA), several of whom had previously failed multiple therapies, the partners said in a statement.
Patients had a stimulation device surgically implanted on the vagus nerve, which was then switched on and off according to a set schedule. Patient response was measured over 84 days and primary endpoints recorded at day 42 using a standard disease activity composite score that takes into account number of swollen and tender joints, patient and physician assessment of disease activity and serum C-reactive protein (CRP) levels.
The results show that stimulating the vagus nerve blocks the production of TNF, one of several cytokines involved in rheumatoid arthritis, the statement said. No serious adverse events were reported.