X-ray image of joint damage from rheumatoid arthritis (Camazine Scott , National Institutes of Health)
14 June 2019. Results from a small-scale clinical trial show an implanted device that stimulates the vagus nerve helps reduce the activity of rheumatoid arthritis. Findings from the trial were presented today at this year’s European Congress of Rheumatology in Madrid, Spain.
Rheumatoid arthritis is an autoimmune disease, where the immune system is tricked into attacking healthy cells, that leads to inflammation of joints — in wrists, fingers, feet, and ankles — and surrounding tissue, affecting some 1.3 million people in the U.S., making it the most prevalent autoimmune disease. In addition, according to the Arthritis Foundation, many people with the disease do not respond to biologics or other drugs, making alternative treatment options necessary.
SetPoint Medical in Valencia, California develops a miniature implanted device called a MicroRegulator designed to stimulate the vagus nerve as a treatment for autoimmune disorders. The vagus nerve pathway extends from the brain stem to the abdomen, connecting other major organs including the heart, esophagus, and lungs. Research by SetPoint’s scientific co-founder Kevin Tracey revealed a neurophysical mechanism called inflammatory reflex that senses problems such as infections and inflammation.
That reflex, says the company, sends signals through the nervous system, including the vagus nerve, affecting the different organs in its path. In the spleen, those signals are received by T-cells, white blood cells in the immune system, which in turn reduce production of cytokines, proteins preventing inflammation, thus allowing inflammation-causing enzymes to operate unchecked. Stimulating the inflammatory reflex aims to moderate immune responses responsible for rheumatoid arthritis, without suppressing these responses completely or the entire immune system.
The clinical trial, led by Mark Genovese, director of Stanford University’s Rheumatology Clinic, enrolled 14 individuals with rheumatoid arthritis that did not respond to drug treatments. Participants were all implanted with MicroRegulator devices, but randomly assigned so 11 of the 14 taking part received 1 minute of vagus nerve stimulation once or 4 times a day for 12 weeks. The other 3 participants were implanted with sham devices that did not stimulate the vagus nerve.
The study team looked primarily for adverse effects from the treatments, but also changes in rheumatoid arthritis disease activity scores, as well as standard scales of clinical disease response, and levels of inflammatory proteins. Science & Enterprise reported on the opening of the clinical trial in March 2018.
The results show the surgical procedures to implant the MicroRegulator devices were generally well tolerated, with 2 cases where adverse events occurred that the study team says were resolved without “clinically significant” consequences. No other treatment or device-related adverse effects were reported. Participants receiving vagus nerve stimulation reported less disease activity than participants implanted with sham devices, as well as lower clinical response measures, and lower levels immune-system enzymes causing inflammation. In fact, participants receiving stimulation once a day reported less disease activity than those receiving treatments 4 times a day.
“Our pilot study suggests this novel MicroRegulator device is well tolerated and reduces signs and symptoms of rheumatoid arthritis,” says Genovese in a European Congress of Rheumatology statement. “These data support the study of this device in a larger placebo-controlled study as a novel treatment approach for rheumatoid arthritis and possibly other chronic inflammatory diseases.”
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