Vagus nerve stimulation receives US approval to treat arthritis

The US Food and Drug Administration (FDA) has approved a vagus nerve stimulator for rheumatoid arthritis – the first such device to be cleared for an autoimmune condition, potentially paving the way for broader uses.

The pill-sized device is surgically implanted along the vagus nerve – a bundle of nerve fibres connecting the brain to most vital organs – in the side of the neck. For up to a decade, it then automatically delivers electrical pulses that stimulate the nerve and reduce inflammation.

Rheumatoid arthritis, like other autoimmune conditions, causes the body to attack its own tissues, triggering excessive inflammation that leads to pain, swelling and even organ damage. It is usually treated with powerful anti-inflammatory drugs that suppress the immune system, raising the risk of infections and cancer. Nearly three-quarters of people with rheumatoid arthritis are unhappy with current treatments and many stop taking them due to side effects.

In a clinical trial of 242 people with moderate to severe rheumatoid arthritis, about 35 per cent of those who received vagus nerve stimulation for 12 weeks saw at least a 20 per cent reduction in symptoms, compared with 24 per cent of those who didn’t receive the treatment. Less than 2 per cent experienced serious side effects, and none of them developed a serious infection.

“The idea of using a safe computer chip instead of expensive, minimally effective drugs with severe side effects should be an attractive option for many patients,” says Kevin Tracey at the Feinstein Institutes for Medical Research in New York. He developed the device about two decades ago as part of the US health technology company SetPoint Medical, though he is no longer with the business.

This approval marks a significant step towards one day using vagus nerve stimulation to treat a range of inflammation-related conditions, including heart failure, diabetes and even neurodegenerative conditions like Parkinson’s, says Stavros Zanos at the Feinstein Institutes of Medical Research, a New York-based research center. SetPoint Medical’s device is already in clinical trials for multiple sclerosis and inflammatory bowel disease.