A jolt of hope to those with auto-immune disease

The US Food and Drug Administration (FDA) approved a medical device recently that offers new hope to patients incapacitated by rheumatoid arthritis (RA), a chronic condition often resistant to treatment and usually managed with medications.

Rheumatoid Arthritis

The device represents a radical departure from standard care, tapping the power of the brain and nervous system to tamp down the uncontrolled inflammation that leads to the debilitating autoimmune disease.

The SetPoint System is an inch long device surgically implanted into the neck, where it sits in a pod wrapped around the vagus nerve, which some scientists believe is the longest nerve in the body.

Setpoint Vagus nerve stimulator

The device electrically stimulates the nerve for one minute each day. The stimulation can turn off crippling inflammation and “reset” the immune system, research has shown. Most drugs used to treat rheumatoid arthritis suppress the immune system, leaving patients vulnerable to serious infections.

On a recent episode of the American College of Rheumatology podcast, the SetPoint implant was described as a “true paradigm shift” in treatment of the disease, which until now has relied almost entirely on an evolving set of pharmaceutical interventions, from gold salts to biologics. The FDA designated the implant as a breakthrough last year to expedite its development and approval. It represents an early test of the promise of so-called bioelectronic medicine to modulate inflammation, which plays a key role in diseases including diabetes, heart disease and cancer.

Vagus nerve stimulation

Clinical trials are already underway testing vagus nerve stimulation to manage inflammatory bowel disease in children, lupus and other conditions. Trials for patients with multiple sclerosis and Crohn’s disease are also planned. In a yearlong randomised controlled trial of 242 patients that included a sham-treatment arm, over half of the participants using the SetPoint implant alone achieved remission or saw their disease recede. Measures of joint pain and swelling fell by 60% and 63% respectively. The device’s long-term effectiveness and safety outside a clinical trial are not yet known. The FDA required post-marketing monitoring of patients and adverse events as part of the approval. Surgery involving implants can lead to serious infections resistant to antibiotics, experts noted.

For Dawn Steiner, 58, a speech pathologist, who participated in the clinical trial, the implant has been a game changer. She was diagnosed with rheumatoid arthritis 15 years ago and has tried eight different biologic agents since then. “Before the implant, the doctor would ask where I was in terms of pain on a scale of one to 10, and I would say I was living a six or seven,” she said. “Now I’m about a two.”

The SetPoint device is the product of decades of research spearheaded by Dr Kevin J Tracey, a neurosurgeon who is president and chief executive of the Feinstein Institutes for Medical Research at Northwell Health. Tracey co-founded SetPoint Medical, but now serves as an adviser. He describes the vagus nerve, which originates in the brain and travels to virtually all the organs of the body, as an “on-off switch” for an overactive immune system. “The brain can turn off inflammation as long as the vagus nerve is intact,” he said. “It’s like a brake system in your car.”

Dr David Chernoff, chief medical officer of SetPoint Medical, said, “Drugs find a pathway that contributes to damaging joints in RA patients and try to block it. What we’re doing is completely different. We’re re-educating the immune system through the brain to behave differently,” he added. As a result, he said, “we’re not blocking the ability to fight off infection.” The body needs some level of inflammation, Tracey said, to help heal wounds, fight infections and promote tissue repair.

The price has not been disclosed, but a spokeswoman said it was designed to last for 10 years and would be less expensive than a year’s worth of some rheumatoid arthritis drugs, which can be quite costly.

One key question is whether the implant’s effectiveness will wane over time, said Dr Lou Bridges, chief of the division of rheumatology at the Hospital for Special Surgery and NewYork-Presbyterian/ Weill Cornell Medical Center. “It’s still early days. The proof will be in the pudding,” he said. “I’m hoping they are correct, and this is a revolutionary new way to treat RA without drugs and without side effects. But I’ve heard this story before.”

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