Vagus Nerve Stimulation: The New FDA-Approved RA Treatment
When Electricity Tames the Immune System
It sounds like science fiction: a tiny implant sits on the vagus nerve in the neck of a patient with rheumatoid arthritis (RA), releasing a one-minute pulse of electricity each night. Within weeks, joint pain eases, swelling recedes, and fatigue begins to lift.
This is vagus nerve stimulation (VNS)—a treatment that uses the body’s own neural circuits to regulate inflammation. After decades of relying on medications that broadly suppress the immune system, the FDA in mid-2025 approved the first VNS device for RA. For patients who have run out of medication options, this offers a fundamentally different approach.
Key Takeaways
Vagus nerve stimulation is the first non-drug therapy approved for RA.
It works by activating a built-in anti-inflammatory pathway—not by suppressing immunity.
In trials of patients who had failed biologics, 35–50% experienced meaningful improvement.
Availability is limited now but expected to expand significantly in early 2026.
It’s approved as an alternative to immunosuppression; future research will test whether combining both could enhance efficacy.
How the Vagus Nerve Calms Inflammation
The vagus nerve is the body’s longest cranial nerve, running from the brainstem down through the neck, chest, and abdomen. Along the way, it communicates with the heart, lungs, spleen, liver, and gut.
About two decades ago, researchers discovered an “inflammatory reflex”—a neural circuit in which the vagus nerve can act as a brake on the immune system. When activated, it triggers immune cells (especially in the spleen) to reduce production of cytokines: the proteins that drive inflammation in diseases such as RA, lupus, and inflammatory bowel disease (IBD).
Instead of globally shutting down immunity the way many drugs do, VNS restores balance by tapping into this built-in pathway. A single one-minute pulse can launch a cascade of neurotransmitters that dampen inflammation without increasing the risk of infection.
From Epilepsy to RA: A Device Finds a New Purpose
Vagus nerve stimulators are not new; implanted devices for epilepsy and depression have been used since the 1990s. Those neurological implants inspired a new question: could the same nerve that settles seizures also quiet autoimmune inflammation?
The first large randomized trial—RESET-RA—tested this idea. In 242 adults with moderate-to-severe RA who had failed at least one biologic, daily VNS led to improvements, with 50% of patients experiencing ACR20 response after 24 weeks (ACR20 means a patient improved by at least 20% in several key measures of arthritis activity — including joint pain, swelling, function, and inflammation). Three-quarters of responders were able to remain off biologics while maintaining disease control.
Effects were modest, especially compared with biologics or JAK inhibitors, which typically have a higher ACR20 response up to 70-80%. At the same time, these were patients who were difficult to treat and had failed prior treatments, so improvements in these refractory patients are notably harder to achieve.
| Treatment | ACR20 Rate |
|---|---|
| First-line biologics | 55–70% |
| First-line JAK inhibitors | 60–80% |
| After failing 1-3 biologics | 25–40% |
| Vagus nerve stimulation (RESET-RA) | 35% at 12 weeks; ~50% at 24 weeks |
How Today’s VNS Implants Work
Modern implants activate the cholinergic anti-inflammatory pathway with impressive precision. Here’s what that looks like:
The stimulator delivers a brief electrical pulse to the left vagus nerve.
The signal travels to the brainstem and then to the spleen.
Immune cells reduce cytokine production, dialing down inflammation at its source.
The SetPoint implant used in RA trials provides a nightly one-minute burst while the patient sleeps and is wirelessly recharged through the skin once a week. Because stimulation is targeted rather than systemic, the most common side effects are mild hoarseness, throat irritation, or temporary voice changes.
Serious complications are rare: in the RESET-RA trial, fewer than 2% of patients experienced significant device-related problems, and no increased risk of infection or malignancy was observed.
Beyond RA: A Platform for Multiple Autoimmune Diseases
While RA was the first disease that received FDA-approval for this device, multiple other diseases are being explored for treatment.
Lupus
Lupus often causes debilitating fatigue and diffuse musculoskeletal pain. In a small study of 18 lupus patients, four days of daily ear-based VNS significantly reduced both pain and fatigue.
Encouraged by these results, researchers at Northwell Health are now launching a larger trial funded by the Lupus Research Alliance that will examine month-long VNS, along with changes in gut permeability and the microbiome. This represents one of the first major attempts to modulate the gut–brain–immune axis in lupus.
Inflammatory Bowel Disease (IBD)
Given the vagus nerve’s deep connection to the gut, VNS has become a natural target for IBD therapies.
In Crohn’s disease, implanted VNS led to clinical remission in 5 of 10 patients who had not responded to medications.
In pediatric IBD, ear-based stimulation reduced fecal calprotectin (an inflammation marker) by more than 50% in 64% of children.
These early findings suggest VNS may reduce gut inflammation without systemic immunosuppression.
Multiple Sclerosis (MS)
MS is fundamentally a neuroimmune disease. Animal studies show that paired VNS—stimulation delivered during specific motor tasks—may promote remyelination by increasing the number and activity of myelin-producing cells.
A device has now received FDA breakthrough designation to test this concept in humans. While early, it underscores a broader shift toward neuromodulation in neuroinflammatory disease.
Why This Matters for Patients
For people living with autoimmune diseases—especially those who have cycled through multiple drugs—VNS represents a potential paradigm shift. Instead of suppressing immunity broadly, this therapy seeks to fine-tune it through the body’s own neural pathways. VNS may be particularly useful for patients with refractory RA and those that are more prone to infections. While the device is currently approved as an alternative to immunosuppressive therapy, an important question is whether it could eventually be combined with immunosuppressive medications to enhance efficacy.
Other potential advantages of VNS include:
No immunosuppression: No increase in infection risk observed in trials.
Convenience: A one-time procedure, weekly recharging, no injections.
Cost stability: Potential for lower long-term costs compared with lifelong biologics.
Suitability for older adults: Particularly appealing for patients prone to infections.
The science is still evolving—researchers are exploring optimal dosing, patient selection, and long-term effects—but the early data are too promising to ignore.
Access and Availability
At the moment, the implant procedure is being performed at only a small number of centers nationwide. Because the device was recently FDA-approved, clinical adoption is still limited. However, several large health systems are preparing to offer the procedure, and availability is expected to expand significantly in early 2026. We help patients understand where implantation is currently offered and what to expect as more centers come online.
