At the 2024 American College of Rheumatology (ACR) Convergence, patients, clinicians, and researchers came together to discuss an innovative treatment for rheumatoid arthritis (RA): neuroimmune modulation. This therapy is a first-of-its-kind treatment for people living with moderate-to-severe RA who haven’t found relief from at least one biologic or targeted medication or can’t tolerate them.
The event, hosted by SetPoint Medical in collaboration with the Global Healthy Living Foundation (GHLF), highlighted the latest data from the RESET-RA trial. Dr. David Chernoff, Chief Medical Officer of SetPoint Medical, shared insights into how this small implantable device can stimulate the vagus nerve to reduce inflammation and improve RA symptoms.
“It is great to be in the vanguard of science, as we help bridge the scientists and the medical experts with the patients and families most in need of these breakthroughs,” said Seth Ginsberg, Co-founder and President of GHLF.
How Does Neuroimmune Modulation Work?
Neuroimmune modulation therapy uses the body’s nervous system, such as the vagus nerve, to synchronize and rebalance the immune system. The vagus nerve acts as a “communication highway” in the body, connecting the brain to key organs like the heart, lungs, and digestive system. It also plays a crucial role in balancing the immune system.
For people with RA, the immune system mistakenly attacks healthy joints and tissues, causing pain and inflammation. The vagus nerve helps regulate this inflammation, working like a “brake.” When stimulated with small electrical impulses, the vagus nerve reduces the levels of inflammatory proteins, such as TNF and IL-6, which are responsible for joint pain and damage due to excessive inflammation.
The therapy involves a small, rechargeable device, about the size of a supplement capsule, implanted in the neck during an outpatient procedure. Once in place, the device delivers tiny electrical signals to the vagus nerve for just one minute each day.
“The procedure takes about an hour, and most patients can go home the same day,” explained Dr. Chernoff.
Once activated, the device calms the overactive immune response that drives RA symptoms. Patients in the trial reported less pain, reduced swelling and tenderness in joints, and better mobility with active treatment. The study indicated that the device also protects joints by reducing bone erosion and improving joint health.
Promising Results from the RESET-RA Trial
The RESET-RA trial enrolled 242 patients with moderate-to-severe RA who hadn’t responded to at least one biologic or targeted therapy. Most participants were women (86 percent), with an average age of 56, and continued taking stable doses of conventional RA medications, like methotrexate, throughout the study.
Key results included:
- Symptom improvement: At 12 weeks, 35 percent of patients receiving active vagus nerve stimulation experienced significant improvement in their symptoms (ACR20), compared to 24 percent in the control group.
- Better outcomes for limited prior biologic use: Patients who had only tried one biologic before the trial saw even greater benefits, with 44 percent improving compared to 19 percent in the control group.
- Long-term relief: After six months, 81 percent of patients managed their RA with the device alone, without needing additional biologics, JAK inhibitors, or steroids.
- Joint protection: The therapy slowed joint damage progression, with benefits visible as early as 12 weeks.
The RESET-RA trial also prioritized safety, and the results were encouraging: The most common side effect was mild, temporary hoarseness caused by the procedure, which resolved on its own. Serious side effects related to the procedure, device or stimulation were rare, occurring in only 1.7 percent of participants, and no patients left the trial due to side effects. Importantly, no deaths were reported.
“Despite treatment advancements, several challenges and unmet medical needs remain for more than 1.5 million adults in the United States who are living with rheumatoid arthritis and its disabling impact,” said Dr. John Tesser, the study’s national principal investigator. “The results from the RESET RA study highlight improvements in disease severity and joint protection, underpinning the continued positive clinical impact of neuroimmune modulation as a potential novel treatment for RA.”
What Does This Mean for You?
Neuroimmune modulation offers a new approach to treating RA by using the body’s own nervous system to control inflammation. Unlike traditional RA medications, this therapy doesn’t rely on suppressing the immune system, which can come with risks like infections.
For patients who haven’t found relief with existing treatments, this device could provide a new path to managing their RA. While additional research is ongoing and the device is pending FDA approval, the RESET-RA trial results suggest that this approach could soon become a key option in RA care.
If you’re living with RA and curious about emerging treatments, let us know. This breakthrough could offer renewed hope for managing the disease.
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Tesser J, et al. Neuroimmune Modulation in Adults with Rheumatoid Arthritis and Inadequate Response or Intolerance to Biological or Targeted Synthetic DMARDs: Results at 12 and 24 Weeks from a Randomized, Sham-Controlled, Double-Blind Pivotal Study [abstract]. Arthritis and Rheumatology. 2024. https://acrabstracts.org/abstract/neuroimmune-modulation-in-adults-with-rheumatoid-arthritis-and-inadequate-response-or-intolerance-to-biological-or-targeted-synthetic-dmards-results-at-12-and-24-weeks-from-a-randomized-sham-control/.
