New Device Offers Hope for Rheumatoid Arthritis Sufferers, Reducing Reliance on Medication
Rheumatoid arthritis (RA), a chronic autoimmune disease causing painful joint inflammation, affects millions. While medications can manage symptoms, they often provide incomplete relief and can lose effectiveness over time. Now, a novel device implanted in the neck is showing promising results, potentially offering a new treatment avenue for those struggling with RA.
How the Device Works: Targeting the Vagus Nerve
The SetPoint System, developed by SetPoint Medical, works by stimulating the vagus nerve, a major nerve connecting the brain to many organs, including those involved in the immune system. Researchers believe modulating this nerve can definitely help rebalance the immune response and reduce inflammation associated with RA.
“Most patients have a partial response to current drugs,” explains Dr. Steven Bridges, a physician and chief of rheumatology at Hospital for Special surgery and Weill Cornell medical College in New York City. “Furthermore, even with important initial improvement, medications can become less effective as time goes on.”
Clinical Trial Results: A Significant Improvement
A recent late-stage clinical trial involving 242 RA patients, all of whom had previously tried and failed to achieve adequate symptom control with medication, evaluated the device’s efficacy. Participants were randomly assigned to receive either the active SetPoint System or an inactive “dummy” implant.
The study revealed that after 12 weeks, 35% of patients receiving the active device experienced at least a 20% reduction in their RA symptoms, compared to 24% in the control group.
Interestingly, the trial continued with all patients receiving the active implant.By the end of this phase, over half of the participants in both original groups reported a symptom improvement of at least 20%. Long-term follow-up data,after one year,indicated that 75% of patients were able to discontinue their RA medications altogether.
Safety Profile and Potential Risks
The initial 12-week phase of the trial showed a low incidence of serious side effects, with 1.7% of patients experiencing mild to moderate hoarseness related to temporary vocal cord dysfunction during the implantation process. No serious adverse events were reported during the second half of the trial, and no participants withdrew due to safety concerns.
Dr. Bridges notes, “The short-term risks associated with the surgical implantation appear to be minimal.”
However, he also emphasizes the need for caution, stating, “Long-term data is currently limited. any approved treatment requires ongoing studies to assess the durability of the response and identify any potential delayed side effects.”
Who Could benefit?
Experts believe the setpoint System could be particularly beneficial for individuals who cannot tolerate RA medications due to increased risk of infection or other adverse reactions.
“This could serve as an option to medication for patients who don’t respond well to drugs, prefer to avoid them, or even as a first-line treatment for those currently medication-free,” says Dr. Bruno Bonaz, a professor emeritus and researcher at Grenoble Alpes university in France, who has extensively studied the technology.
Availability and Cost
setpoint medical anticipates launching the SetPoint System in select U.S. cities later this year, with nationwide availability expected in early 2026. pricing information has not yet been released.
Source: https://www.everydayhealth.com/rheumatoid-arthritis/treatment/new-neck-device-rheumatoid-arthritis/
