7 Ways SetPoint Is a Different Therapy for RA

If you have been living with rheumatoid arthritis (RA), you already know the cycle: try a medication, wait, adjust the dose, balance the side effect risks, and hope it keeps working. When it stops¹, you move on to the next one. Despite the availability of multiple drugs, research shows² that only about a third of RA patients feel like they have enough RA medication choices, and up to half discontinue their treatment within two years.

SetPoint Therapy takes a fundamentally different approach. It is a small, implanted device-based treatment that stimulates the vagus nerve for just 1 minute daily. Studies have shown that signal can help the body regulate its inflammatory response and restore the immune balance, or “set point.”

Here are seven ways SetPoint Therapy stands apart from traditional RA treatments.

1. An Entirely New Category of Treatment

SetPoint Therapy is the first FDA-approved medical device using neuroimmune modulation to treat rheumatoid arthritis. SetPoint Therapy represents an entirely new category, one that uses electrical activation of the body’s vagus nerve to regulate the immune response by restoring a function that is not working well in patients with RA.     

This new approach is grounded in established scientific research showing that vagus nerve dysfunction is one of the root drivers of the immune imbalance that leads to RA³. Research has also shown⁴ that RA patients with stronger vagus nerve activity respond better to traditional RA medications, further pointing to the central role this pathway plays in the disease. SetPoint Therapy is the first treatment designed to address that root issue directly.

And while the general category is new, the underlying technology is not. Vagus nerve stimulation has been used in more than 150,000 patients over the past 20 years for different indications. The SetPoint System applies these established principles of stimulating the vagus nerve to autoimmune disease for the first time, offering a treatment path that did not exist before.

2. SetPoint Works WITH Your Immune System

The RA medications developed 15-20 years ago were designed to block specific pathways of the immune system. Most biologics work by blocking specific proteins called cytokines. DMARD pills broadly inhibit, or block, immune activity. That approach helps reduce inflammation, but it also suppresses the immune system and reduces the body’s ability to fight infections, which increases the risk of significant side effects.

SetPoint Therapy works differently. It uses a process called neuroimmune modulation – a medical device signals the vagus nerve to help restore the immune cells driving RA. In RA, immune cells release inflammatory markers that damage the joints. Sending very specific signals through the vagus nerve help restore these cells, shifting them from angry attackers into a restorative state that helps repair damaged tissue and calm inflammation. This addresses the root cause of RA without broadly suppressing the immune system’s protective function. Think of it as less like hitting the brakes and more like adjusting the thermostat.

As Lynn, who participated in the RESET-RA study that led to FDA approval of the SetPoint System, described it: “This is a natural process. It’s just stimulating a part of your body. It’s telling it, ‘Hey, we need you to work.’”

Individual results may vary. Patient story shared with permission.

Because SetPoint doesn’t suppress the immune system, it doesn’t limit your future treatment options the way some RA medications can. Some patients may still use other medications alongside SetPoint Therapy, depending on their individual treatment plan. If you’re interested in and eligible for SetPoint, your rheumatologist can work with you to determine the best approach.

3. No Pills, No Infusions, No Injections

SetPoint Therapy doesn’t work through medications. It does not need pills or injections. There are no infusion appointments to plan around. The treatment is delivered by a small device, about the size of a large multivitamin, placed on the vagus nerve during a single outpatient procedure.

For people who have spent years managing their life around medication schedules, that shift can be significant. As Lynn put it: “You’re implanted, your little scar heals, and you’re done.”

In the RESET-RA clinical trial, patients showed continued improvement through 12 months of follow-up, with 75% managing on SetPoint Therapy without the addition of a biologic or JAK inhibitor. While the study included participants taking generic drugs like hydroxychloroquine or methotrexate, being on those drugs is not needed to use SetPoint Therapy.

You’re implanted, your little scar heals, and you’re done.

• Lynn M., North Carolina

4. An RA Therapy That’s Just One Minute a Day

The SetPoint System delivers therapy automatically. Once your rheumatologist programs the device, it stimulates the vagus nerve for one minute each day. There’s nothing to turn on, and nothing to administer. Your rheumatologist can personalize the time of stimulation to best fit your life, and the activation process includes a gradual increase in stimulation level to make sure the therapy is comfortable for you.

Sensation varies from person to person. Some people feel a light tickling sensation, a brief cough, or slight changes in their voice during that one minute of stimulation. Others may not notice it at all.

Your only responsibility, apart from regular doctors’ visits, is charging the device for a few minutes a week by wearing a wireless charger around your neck.

With SetPoint Therapy, the time commitment is just seconds per day and minutes per week.

5. One Procedure, Built to Last

The SetPoint Implant is placed on the vagus nerve during a single outpatient procedure that typically takes 60 to 90 minutes. The implant is placed through a small (~1-2 inch) incision on or near a natural crease in the skin. Most people return home the same day and can typically resume normal daily activities the following day.

Once you’re cleared by your surgeon, you’ll visit your rheumatologist’s office and your device will be activated. The implant will automatically deliver therapy for one minute each day for up to 10 years.

Because SetPoint Therapy involves a single implant procedure, there are no ongoing maintenance costs once your therapy is activated. No monthly prescription co-pays, no recurring pharmacy trips, no annual reauthorizations to keep your treatment going. Your care team will work with you and your insurance to determine your coverage and out-of-pocket costs for the procedure itself.

Speak with a Patient Activator

Getting more information is easy. One of our Patient Activators is ready to provide you with information about the therapy and answer questions you may have.

Connect with an Activator

6. It Goes Where You Go

Because the SetPoint System is an implanted device, your treatment travels with you. There are no temperature-sensitive medications to store, no clinic visits required for treatment delivery, and no infusion appointments to schedule.

The only accessory is a wireless charger that you place around your neck once a week until it beeps to indicate the charge is complete. When traveling, just pack it in the carrying case, and if you’re flying, you’ll keep your patient ID card handy for security. SetPoint Therapy is delivered automatically regardless of where you are.

Ken, who tried the SetPoint System after not responding well to RA medications, described it this way: “The treatment is, on a day-to-day basis, invisible to your life. You only see the impact on your life. You see the symptom reduction. You see that you’re doing more things, but you don’t experience any of the hassle that goes with conventional treatments.”

Individual results may vary. Patient story shared with permission.

For more on the day-to-day routine of charging, stimulation, and activity, see Living with SetPoint Therapy.

7. Long Term Effectiveness Without Typical Safety Risks

Many RA medications come with serious risks that build up over time, including infections, certain cancers, and cardiovascular issues. That’s because most biologics and JAK inhibitors work by suppressing parts of your immune system, and that suppression continues for as long as you’re on the drug.

The treatment is, on a day-to-day basis, invisible to your life. You only see the impact on your life.

• Ken H., Rhode Island

The SetPoint System works differently. Because it activates your body’s natural anti-inflammatory pathways rather than suppressing the immune system, it doesn’t carry the same long-term risk profile. In the RESET-RA study, device-related side effects, those deemed to be associated directly with the therapy, were infrequent and typically mild or temporary, with vocal hoarseness most frequently reported. Serious adverse events that were related to the device or therapy were uncommon, occurring in fewer than two percent of patients, and occurred within 3 months of device placement. Importantly, there were no long-term serious adverse events related to the device or therapy, and no serious infection, cancers, or major cardiovascular issues related with the device or procedure that occurred during the 12-month trial. Researchers concluded that SetPoint Therapy produced durable clinical benefits with a favorable safety profile for patients with moderate to severe RA who do not respond to, or cannot tolerate, advanced RA therapies like biologics or JAK inhibitors.

In other words, once you heal from the procedure, the ongoing safety risks look very different from what comes with years of traditional RA medications. Your rheumatologist and your surgeon can discuss treatment risks and benefits with you.

Is SetPoint Therapy Right for You?

SetPoint Therapy is for adults with moderately to severely active RA who have tried one or more biologics (e.g. Humira, Enbrel, Cimzia, Remicade, Rituxan, Actemra, or Orencia) or JAK inhibitors (e.g. Xeljanz, Rinvoq, or Olumiant) and didn’t get adequate results, lost their response over time, or couldn’t tolerate the side effects. If your current treatment isn’t giving you relief, or you haven’t been able to tolerate it, SetPoint Therapy may be worth discussing with your rheumatologist.

You can complete a short form to find out if it might be a good fit for you. If you’re a potential candidate, you’ll be connected with a Patient Activator from our team who can help answer your questions and walk you through next steps.

You may also want to bring up SetPoint Therapy at your next visit directly with your rheumatologist. They can help you evaluate whether the SetPoint System might be appropriate based on your treatment history and current disease activity.