This implant is the 1st non-drug therapy for rheumatoid arthritis patients

Rheumatoid arthritis is one of the chronic diseases caused by inflammation. It’s a painful, life-altering condition — and recently, the FDA approved a new treatment for it that Dr. John Tesser says has the potential to drastically improve patients’ quality of life.

It’s called SetPoint therapy — named for the company that created it, SetPoint Medical.

It’s a tiny, pill-sized implant that’s inserted into the body. Tesser is a rheumatologist here in the Valley, and a professor at University of Arizona's medical school. He served as the national principal investigator during the trial period for Setpoint therapy.

Tesser told The Show that the implant works by stimulating the vagus nerve in the neck, which then sends signals into the spleen.

Full conversation

DR. JOHN TESSER: In the spleen, there are immunologically active cells that are able to produce inflammatory chemical messengers called cytokines. And these cytokines, if they're up-regulated, will promote inflammation. And if they're down-regulated they will downregulate inflammation. And the device can set off an electrical signal to down-regulate the splenic cells.

SAM DINGMAN: So it's a very small device, right? It's like the size of a pill, right?

TESSER: Yes. And this device as being an integrated one, has a battery in it. The device of course is in the neck and it is sewn by putting it into a silicone pod around the left vagus nerve by a neurosurgeon or a very experienced ear, nose and throat surgeon.

The procedure takes maybe an hour. It's an outpatient procedure. And the device is programmed to release a stimulation for one minute a day. One minute of an electrical pulse can cause a down-regulation of the immune system.

DINGMAN: This therapy was recently approved by the FDA, but prior to that approval in the clinical trials, as I understand it, the results were remarkable, right? In terms of the difference that this treatment made in patients day to day.

TESSER: Pain, pain and function. Yes, absolutely. And only 25% of patients by the end of one year had had any advanced therapy added to the device therapy, which is also remarkable.

DINGMAN: A lot of the other ways of treating rheumatoid arthritis, which I realize they, this SetPoint therapy that we're talking about doesn't replace, but in many cases other treatments are fairly invasive and carry some other health risks with them, right?

TESSER: Yeah, that's very true. So there are a number of historical inflection points to bring out about this therapy. One, it's the first device that's been approved to treat rheumatoid arthritis. It's very possible, it's very likely, I'm sorry, that SetPoint is going to start doing clinical trials in multiple sclerosis and inflammatory bowel disease.

DINGMAN: Oh, wow.

TESSER: And it's the first therapy that's not a drug therapy. So the therapies you were alluding to are all drug therapies. We have disease modifying antirheumatic drugs, including methotrexate and flutamide and sulfasalazine. These are pills. And then we have the biologic therapies, including things that people probably know about over the years. Enbrel, Remicade, Humira and many others.

And then there are the newer pills called JAK inhibitors. And all of these therapies are drug therapies, which have potential adverse events, major adverse cardiovascular events like heart attacks, strokes, blood clots in other areas of the body, serious infections like pneumonias that put people in the hospital, or cancer.

DINGMAN: Yeah.

TESSER: All of the drugs that we have have certain concerns about their associations with these things. And one of the amazing advantages of this therapy is that I want to point out to people, most people do not get side effects on drugs. And during the course of the trial, patients who are not doing well enough could have advanced therapies added to the electrical stimulation device.

DINGMAN: Oh, interesting. So it can work in concert with those therapies.

TESSER: Yes, and patients who are on those therapies could have this added to it.

DINGMAN: For folks who have maybe heard of rheumatoid arthritis, but don't necessarily know what the day to day experience of living with it is. Could you describe just how debilitating this condition can be?

TESSER: Yes, and I'm glad you brought this up. What happens is the person's own immune system winds up recognizing different proteins and other small molecules within cells as being foreign. And it's kind of like your army now is turning on yourself and there's a civil war that's being waged. The weaponry that's used is inflammation, the inflammation that's targeted to different organs.

And specifically, and most prominently in rheumatoid arthritis, or the joint tissue can lead to pain and swelling and stiffness, which can lead to dysfunction. Anyone who's sprained an ankle, that's inflammation. And they know what that's like. Imagine that in multiple joints, in all your fingers and your toes and other major joints. And the inflammation over time can cause damage that can lead to deformities and worsening of function.

Fatigue is the second most reported symptom after pain. So living with this disease is basically hell, to be honest with you.

DINGMAN: Yes. And so is that the reason that this implanted device therapy seems to hold potential for treating those other conditions like lupus, IBS, multiple sclerosis, because those, too, are caused by the effects of severe inflammation.

TESSER: That's exactly right. So you can think of it like the inflammation is the weaponry that's the source of all of the symptoms and the damage that happens in organs in these diseases. And if this type of therapy can downregulate the common source of the damage causing and symptom causing effects of a disease, then this has potential to, to help many of the autoimmune diseases and potentially other diseases that are not necessarily autoimmune. But the inflammation is the common denominator.

DINGMAN: Well, you know, Dr. Tesser, we've been talking about this treatment in almost like miraculous terms in terms of the potential for the difference it seems to be able to make in patients lives.

I listened to an interview that you gave a while back on this subject and you mentioned that initially when you heard about it, you were a little skeptical. Obviously you've come around. I'm wondering what your skepticism was and whether you still have any reservations about it.

TESSER: My skepticism was one that all rheumatologists and other people should have. You know, stimulating a nerve to control an immunologic disease. You should be skeptical until you delve into the basic science and that explains it. And interestingly enough, obviously I now understand it. And I saw the translation of this in the clinical trials, the Phase 2 and now the Phase 3 trials.

And now I'm having to go out and help with others to educate my peers about this. They're all very excited, right, because once you understand the science and the translation, it becomes very apparent that this is a, a really great thing.