USA: FDA approves vagus nerve stimulator for rheumatoid arthritis

From healio.com/news

Key takeaways:

• Implantable device stimulates the vagus nerve for 60 seconds daily.
• The device activates anti-inflammatory and immunomodulatory properties in the body.

The FDA has approved the SetPoint System, a vagus nerve stimulator from SetPoint Medical, for the treatment of rheumatoid arthritis.

The device is an implantable, integrated neurostimulator about the size of a vitamin tablet that stimulates the vagus nerve for 60 seconds once daily with the goal of activating natural anti-inflammatory capabilities within the body. The device has also demonstrated the capacity for immune modulation.

“The approval of the SetPoint System, the first-in-class neuroimmune modulation platform, represents a transformative milestone in the management of autoimmune diseases,” Murthy V. Simhambhatla, PhD, CEO of SetPoint Medical, said in a company press release. “We are committed to improving the health of people living with RA and look forward to working with providers and payers to make our innovative therapy accessible to their patients.

“We plan to introduce the SetPoint System in targeted U.S. cities this year, followed by expansion across the country starting in early 2026,” he added.

The FDA approval follows the double-blind, placebo-controlled RESET-RA study, in which patients underwent the daily vagus nerve stimulation and were assessed at 12 weeks. According to the researchers, the SetPoint System demonstrated statistically significant improvement over placebo in terms of ACR20 response at that time point (P = .0209).

Further results showed that for patients with one prior exposure to a biologic or traditional synthetic disease-modifying antirheumatic drug, 44.2% of those in the vagus nerve stimulation group achieved ACR20 response, compared with 19% of controls (P = .0054).

“This is a landmark study in the treatment and care of rheumatoid arthritis,” John Tesser, MD, FACP, FACR, MACR, of Arizona Arthritis & Rheumatology Associates and Midwestern University, who was a principal investigator of the RESET-RA study, said in the release.

“The study met its primary efficacy endpoint of ACR20 at three months, with improvements observed in ACR response rates and disease activity metrics through 12 months of follow-up,” he added. “75% of patients in the study were free of biologic or targeted synthetic DMARDs at 12 months.”

SetPoint is additionally planning to evaluate its device for the treatment of other autoimmune diseases, including multiple sclerosis and Crohn’s disease, according to the release.

https://www.healio.com/news/rheumatology/20250731/fda-approves-vagus-nerve-stimulator-for-rheumatoid-arthritis 

Let’s Raise Awareness About Arthritis

From arthritis.org

Every May is Arthritis Awareness Month, an opportunity to inform even more people about this complex family of debilitating diseases 

While most people have probably heard of arthritis, it’s likely that many of them don’t know much about the impact of arthritis, the #1 cause of disability in the United States. That’s why, during Arthritis Awareness Month every May, the Arthritis Foundation calls extra attention to this painful and debilitating condition that affects nearly 60 million men, women and children in the U.S.

In 1972, at the urging of the Arthritis Foundation, Congress and President Richard M. Nixon designated May as National Arthritis Month — a special time to emphasize research, service and education around arthritis, and to raise funds to support the cause. Every May since then, National Arthritis Month has been marked by efforts to elevate the public’s awareness of arthritis.

The Arthritis Foundation works to share little known facts so that more people realize the serious impacts arthritis has, like the real-life statistics below.

Basic Facts About Arthritis
 

• About 1 in 4 adults and hundreds of thousands of children in the U.S. have been diagnosed by a doctor with a form of arthritis or related illness.
• Contrary to the common misconception, it’s not just an “old person’s” disease. About two-thirds of those living with arthritis are aged 65 and under.
• There are more than 100 types of arthritis and related rheumatic diseases.
• As our nation’s top cause of disability, arthritis costs the U.S. economy over $300 billion annually in medical bills, lost wages and associated expenses.
• Most people with arthritis also have comorbidities — accompanying conditions, like heart disease, diabetes and obesity — that further jeopardizes their health.

 
More Interesting Tidbits
 
The Centres for Disease Control and Prevention (CDC) offers more eye-opening facts:

• Nearly 26 million of those with arthritis in the U.S. are unable to do everyday activities. That includes everything from walking to doing household chores to engaging in work or social situations.
• More adults in rural areas of the U.S. are affected by arthritis — 1 in 3 — than in urban areas. Over half reported being limited by arthritis.
• 1 in 3 adults with arthritis are not physically active (30%), have fair to poor health (33%) and have severe joint pain (33%).  

Solutions to Help Conquer Arthritis
 
Since the Arthritis Foundation began in 1948, we’ve been the leading, most trusted non-profit organization dedicated to serving the arthritis community and ultimately finding a cure— through research, advocacy, educational resources and community connections.
 
Resources to Check Out

• Start by learning as much as you can about arthritis.
• Listen to our Live Yes! With Arthritis podcasts, covering all kinds of topics.
• Our webinars can also help you take control of your arthritis.
• Our e-books dig in to ways you can live better with arthritis in all sorts of ways.

https://www.arthritis.org/about-arthritis/arthritis-awareness-month