SetPoint Therapy for Treatment of Rheumatoid Arthritis

SetPoint Therapy is a different approach to treating RA when compared to traditional drug-based treatment options.

SetPoint Therapy is a device-based therapy that works with your body by activating your body’s natural immune pathways known to have an anti-inflammatory effect.4 These immune pathways are thought to be dysfunctional in RA patients, which causes uncontrolled inflammation, the root cause of RA.3

The SetPoint System includes placement of a device on your vagus nerve with the intent to jumpstart, or activate, these pathways to reduce inflammation and restore your body’s inflammatory balance, or setpoint. In comparison, the typical approach of biologics and JAK inhibitors is to block/inhibit or target specific inflammatory markers or pathways.

Yes, the SetPoint System has been clinically proven to be safe and effective. Specifically, the SetPoint System is indicated for use in the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response, or intolerance to one or more biological or targeted synthetic disease-modifying antirheumatic drugs such as TNF inhibitors or JAK inhibitors.

To support its FDA approval, the SetPoint System was evaluated in a clinical study of 242 patients which successfully met its primary endpoint for efficacy, and the device, its placement, and stimulation therapy were considered safe. The study now includes data through 12 months of follow-up that demonstrates sustained improvements in tender and swollen joints as well as disease activity; nearly half of patients treated with SetPoint Therapy for 12 months are in low disease activity or remission.*

The study also demonstrated that SetPoint System, its placement procedure as well as stimulation were safe and well tolerated. Serious adverse events related to the placement of the SetPoint System were observed in 1.7% (4 of the 242 people implanted) in the peri-operative 3 months, and no (0%) additional related serious events through 12 months of long-term follow-up.

SetPoint Therapy is intended to reduce inflammation by activating the body’s natural pathways while preserving the immune system’s primary protective functions.4,5 In the study, there were no serious infections, cancers, or major cardiac events associated with SetPoint Therapy.

This is how Dawn, who participated in the RESET-RA study, describes her personal experience with SetPoint Therapy: “I used to not be able to walk around the block, now I can walk for over an hour without any pain.”

Your provider will review the risks associated with the SetPoint Therapy before referring you for the therapy. 

The level of effectiveness and time to effectiveness varies from patient to patient.  In the RESET-RA study, improvement in the number of tender and swollen joints and disease activity was seen by 3 months after starting stimulation. This response rate was higher in patients who had exposure to just one prior biologic.

While results vary, this is how RESET-RA participant, Patty, describes her experience: “After the device was activated, within a month, I started noticing differences. I wasn’t as tired […] I think the biggest thing was I started doing things again.”

The SetPoint System is placed on your vagus nerve during an outpatient procedure under general anesthesia.  There are some risks associated with the device placement.  Serious safety events related to the device, or its procedure, were observed in 1.7% (of the 242 study participants) in the RESET-RA study. All events were anticipated and consistent with learnings from more than 100,000 patients who have been treated with other vagus nerve stimulation devices for other indications over the past 20 years.

Other non-serious events, which typically resolve over time, include pain, redness and swelling at the implantation site, sore throat, cough or tingling as well as risks of vocal cord complications, that typically present as hoarseness – this was the most commonly observed side effect of the implant procedure occurring in about 5% (11 of 242 study participants).

Here is how Lynn, a RESET-RA study participant who experienced one of the more severe cases of hoarseness, described her experience with the side effect:

“It is normal to be hoarse right after surgery, but I couldn’t really speak. A whisper is all I could get out. So, I had to see a vocal cord specialist… I had a procedure done and the next day, I could talk like I had my voice back. Now, I can speak in a normal voice, and can be heard.

But, as I’ve told everyone, if I had lost my voice completely, I would still have the implant because not being able to talk is fine when all my pain was taken away. Knowing what I know now, and having the effects with the vocal cord, 100% would still do SetPoint, 100%.”

The SetPoint System activates your natural immune pathways to reduce inflammation and symptoms of disease without compromising your immune system – allowing for RA symptom reduction while preserving the body’s ability to fight infections. 5,6,7  In the 12 months of follow-up in the RESET-RA study, there were no serious infections, cancers, or major cardiac issues associated with the SetPoint Therapy.

Your provider will discuss the risks of SetPoint Therapy with you.

The first step of activating your SetPoint Therapy is to discuss this new therapeutic option with your rheumatologist or their team. To check if your rheumatologist offers SetPoint Therapy, please connect with the SetPoint Activator, or talk to your rheumatology provider.

Once you and your rheumatology care provider decide that SetPoint Therapy is the right option for managing your RA, they will refer you to a surgeon trained to place the SetPoint Implant. Next step would be to meet with the surgeon for a pre-operative visit to ensure that the procedure is right for you.

The actual placement procedure will be scheduled after your first surgeon appointment.  The implant is typically placed during a 60-90 minute outpatient procedure, meaning that you typically return home the same day as the procedure and can resume activities of daily living the following day.8 The implant is placed via a small, 1-inch incision near a crease in the skin. You return to the surgeon a few days after the procedure for post-operative check. Click here to see examples of what the scar may look in patients who have had the SetPoint System.

A couple of weeks after the Implant is placed, you return to your rheumatologist who activates your therapy while ensuring that the stimulation is comfortable for you.  Once activated, the therapy is automatically delivered daily. All you need to do is charge your device for a few minutes once a week. Your rheumatologist will continue to manage your RA. During these appointments, your therapy can be adjusted, if desired.

While results vary, this is how Lynn, a RESET-RA study participant, described the experience of her Implant placement procedure: “You’re implanted, your little scar heals, and you’re done. It was easily implanted. I had no downtime. I was literally in and out in the same day.”

The SetPoint Implant is MRI conditional. Patients with implants are provided with a therapy parameter card to present to healthcare providers with the MRI conditions and considerations. Patients implanted with the SetPoint System should not undergo MRI scans within 1 hour before or after the scheduled therapy time.