A private donation from Sally Cahill, USA, to researchers at Karolinska Institutet could make a new treatment for severe rheumatoid arthritis a reality. The method, which involves stimulating a nerve in the ear with a weak electric signal, has so far delivered promising results.
Jon Lampa, professor of rheumatology at Karolinska Institutet, and his research group have received a donation from Sally Cahill, USA, mediated by the Feinstein Institutes , a medical research centre in New York with which the group is collaborating. The donation is worth almost SEK 10.8 million and is earmarked for the TRAVAGA clinical study.
"The donation means a great deal to us and means that we can carry out this valuable study," says Professor Lampa at KI's Department of Medicine in Solna, and clinical manager at Karolinska University Hospital.
The study currently comprises six clinics in Sweden: Karolinska University Hospital, the Rheumatology Centre in Stockholm and rheumatology clinics in Umeå, Örebro, Lund and Malmö. Launched last March, the study, which is coordinated by the Department of Medicine in Solna, is expected last two years.
Stimulated vagus nerve suppresses inflammation
The background to the study is the discovery that the nerve and immune systems are closely linked. Back in the early 2000s, research showed that the vagus nerve, which runs from the brain stem, down through the neck and on to the heart and guts, can affect inflammatory processes.
Stimulating the nerve can activate the inflammatory reflex, a communication pathway that helps the body to suppress inflammation.
A published phase 3 study in the USA called RESET-RA , which involves patients with severe rheumatoid arthritis that have not responded to drugs, tested if a surgically implanted stimulator placed on the vagus nerve in the neck could suppress chronic inflammation.
After the first three months of the study, the researchers could see distinct differences in effect in treated patients compared to controls - 35 and 24 per cent respectively.
All patients then received the treatment. A year later, almost 60 per cent of them had attained the therapeutic objective and their disease had become approximately 20 per cent less active.
A possible alternative to surgery
This technique is easier on the body than drugs but requires surgery. The researchers are therefore examining whether the vagus nerve can be stimulated instead with a weak electric current via the skin of the left outer ear. The nerve is stimulated for five minutes morning and night, with the control group receiving sham stimulation on a part of the ear that lacks contact with the vagus nerve.
"We're now trying to ascertain if this also has an anti-inflammatory effect," says Professor Lampa. "We also need to clarify the effect of the treatment on pain and fatigue, disease parameters that were not evaluated in the previous study."
The study is randomised and placebo-controlled and recruits patients with rheumatoid arthritis who have not responded adequately to currently available treatments.
"We need to find out if this non-invasive therapy can have positive effects and suppress the morbid activity and pain of rheumatoid arthritis. If it does, it can be an important component of other treatments, some of which aren't sufficiently suppressive."
Rheumatoid arthritis in brief
Rheumatoid arthritis is an inflammatory disease that often debuts in the small joints of the hands and feet. The joints swell, become tender and cause pain.
The disease causes joint pain on both sides of the body, especially in the smaller joints of the hands and feet. If the inflammation persists, it can damage tissue in and around the joints and impair movement.
Rheumatoid arthritis can also cause inflammation in other parts of the body, such as the lungs, the pleura, the pericardium, the eyes and the blood vessels.
The disease is incurable, but drugs and physiotherapy can reduce the inflammation and provide some pain relief.
