Researchers recently shared promising findings from the RESET RA study, which tested a small implant designed to stimulate the vagus nerve to help treat rheumatoid arthritis (RA). This innovative approach may become an approved treatment option soon, potentially as early as this year.
Dr. Kevin J. Tracey, president of Northwell Health’s Feinstein Institutes for Medical Research, accidentally discovered that brain signals can control inflammation through the vagus nerve. While studying a molecule for RA, his team noticed it reduced levels of certain inflammatory chemicals, revealing the vagus nerve’s crucial role.
In 2007, Dr. Tracey co-founded SetPoint Medical to develop a vagus nerve-stimulating implant aimed at reducing chronic inflammation in autoimmune conditions like RA.
The vagus nerve plays a key role in the body’s “anti-inflammatory pathway.” By delivering tiny electrical pulses to this nerve, researchers aim to diminish inflammatory substances such as TNF, IL-1-beta, and IL-6. Research also suggests that vagus nerve stimulation may influence other key inflammation-related processes.
In the RESET RA study, participants received a small device (about the size of a vitamin tablet) implanted on the left side of the neck, delivering a 60-second daily electrical pulse to the vagus nerve. Early results were promising:
Vagus nerve implants are not new and have been used for decades to treat conditions like epilepsy, depression, and stroke. The procedure is considered relatively safe, with serious complications in the RA trial being rare (reported in only 1.7% of cases). During the brief daily stimulation, some patients experienced voice changes, and there’s a small risk of post-surgery issues. However, safety data so far has been reassuring.
Researchers, including Dr. Tracey, Dr. John R.P. Tesser, and Dr. Vibeke Strand, anticipate the device may receive FDA approval for RA treatment as soon as 2025. Unlike the typical drug approval process, medical devices undergo evaluation by a different FDA division, involving more specialists like rheumatologists, neurosurgeons, and immunologists.
Biologic medications for RA can range from $50,000 to $100,000 per year. While the exact cost of the vagus nerve stimulation implant and procedure is unknown, it is expected to be more cost-effective over time, as the device is a one-time implant rather than a recurring medication expense. In the RESET RA trial, 81% of participants required no additional biologic medications post-implant, indicating potential significant savings, although real-world results might vary.
Initially, this approach might be offered to patients who have tried multiple RA therapies without success. If the device continues to show positive results, it could see wider application. Patients with other autoimmune conditions — such as Crohn’s disease, multiple sclerosis, and potentially metabolic or inflammatory bowel diseases — might also benefit from vagus nerve stimulation in the future.
Dr. Tracey highlights that people with RA are increasingly seeking alternatives to expensive immune-suppressing drugs. This device has the potential to fulfill that need. More trials will help determine if vagus nerve stimulation can become a standard, less medication-focused option for managing RA and other autoimmune conditions.