Implantable Device Stimulates Vagus Nerve, Helps RA Patients

A new clinical trial has found that stimulating the vagus nerve with an implantable bioelectronic device has proved beneficial for patients with rheumatoid arthritis (RA). The study was performed by the Academic Medical Center/University of Amsterdam, the Feinstein Institute for Medical Research and SetPoint Medical.

“This is the first study to evaluate whether stimulating the inflammatory reflex directly with an implanted electronic device can treat RA in humans, ” said Professor Paul-Peter Tak, M.D., Ph.D., FMedSci, the international principal investigator and lead author of the paper at the Division of Clinical Immunology & Rheumatology of the Academic Medical Center/University of Amsterdam. “We have previously shown that targeting the inflammatory reflex may reduce inflammation in animal models and in vitro models of RA. The direct correlation between vagus nerve stimulation and the suppression of several key cytokines like TNF [tumor necrosis factor] as well as reduced RA signs and symptoms demonstrates proof of mechanism, which might be relevant for other immune-mediated inflammatory diseases as well.”

“Our findings suggest a new approach to fighting diseases with bioelectronic medicines, which use electrical pulses to treat diseases currently treated with potent and relatively expensive drugs, ” said Anthony Arnold, Chief Executive Officer of SetPoint Medical. “These results support our ongoing development of bioelectronic medicines designed to improve the lives of people suffering from chronic inflammatory diseases and give healthcare providers new and potentially safer treatment alternatives at a much lower total cost for the healthcare system.”

According to the July 5, 2016 news release, “Of 17 patients with active RA in the study, several patients that had failed to respond to multiple therapies, including biologicals with different mechanisms of action, demonstrated robust responses. The findings indicate that active electrical stimulation of the vagus nerve inhibits TNF production in RA patients and significantly attenuates RA disease severity.”

“Several patients reported significant improvements, including some who had previously failed to respond to any other form of pharmaceutical treatment. In addition, no serious adverse side effects were reported. The emerging field of bioelectronic medicine aims to target disorders traditionally treated with drugs and instead uses advanced neuromodulation devices that may offer significant advantages. SetPoint is developing a novel proprietary bioelectronic medicine platform to treat a variety of immune-mediated inflammatory diseases, using an implanted device to stimulate the vagus nerve.”

Dr. Tak told OTW, “I was surprised to see the efficacy of vagus nerve stimulation in some rheumatoid arthritis patients who had failed multiple anti-rheumatic medicines, including biologicals.”

“Vagus nerve stimulation resulted in a marked decreased in the production of TNF, which is a key cytokine in the pathogenesis of RA.”

Asked if orthopedic surgeons are sufficiently attuned to inflammation, Dr. Tak noted, “Orthopedic surgeons often see the patients when there is destruction of the joint as a result of inflammation. We need more treatment modalities to induce remission of inflammation before degradation of bone and cartilage occurs.”