Neuromodulation device stimulates the vagus nerve to modulate immune response and emerges as an alternative for patients who do not respond well to medicines
A 2.5 centimeter implant placed in the neck to issue a one -minute daily electrical impulses was recently approved by the Food and Drug Administration (FDA), the United States Regulatory Agency for the treatment of rheumatoid arthritis. Baptized from “SetPoint System”the device acts next to the vagus nerve and has the purpose of “re-educate” The immune system, reducing inflammation differently from current therapies.
Rheumatoid arthritis is an autoimmune disease that affects about 1% of the world’s population and, despite therapeutic advances, still represents a major challenge for doctors and patients. The condition, which mainly affects joints, causes chronic pain, stiffness and persistent inflammation.
When not treated properly, it can lead to deformities, loss of joint function and even impairment of organs such as lungs, heart and eyes. The impact on quality of life is great, limiting daily activities and, in serious cases, the patient’s own independence.
The disease reaches 3 times more women than men, and usually arises in the age group of 30 to 50 years. Pain, swelling and prolonged joint stiffness, especially in the morning and at rest, are the main symptoms. “Initially, the disease often affects small joints of the hands, fists and feet symmetrically, but can affect any joint. Fatigue and subcutaneous nodules may also be present.”explains rheumatologist Anna Sylvia Gonçalves Reis, from Einstein Hospital Israelita in Goiânia.
Traditionally, therapeutic arsenal against rheumatoid arthritis includes disease -modifying drugs (so -called DMARS) or biological medications, developed to block specific inflammation molecules. Although effective for most cases, part of the patients do not reach expected remission, loses response over time or not tolerates the side effects. It is precisely to meet this group, known as “Difficult control”, that research continues.
How the implant works
Instead of suppressing the immune system, as current drugs do, the new technology seeks “re-educate” the body controlling inflammation. In one, which involved 242 people (60% of them considered from the difficult control group), the results surprised.
After 12 weeks, 35.2% of individuals who received active stimulation reached the clinical response, against 24.2% in the control group. Among patients who had already used at least one biological drug previously, the difference was even more striking: 44.2% accounted for implant compared to only 19% of controls.
Another important fact was the improvement in disease score, indicator used to evaluate inflammation. More patients in the treatment group reached remission or low activity of the disease in relation to the placebo group. In a one year follow-up, there was also a 60% reduction in pain rates and 63% in the swelling of the joints. The most common severe complication was the hoarseness associated with implant surgery, which occurred in just under 2% of participants.
For the doctor of Einstein, the approval of the device represents a “New Frontier” in the management of rheumatoid arthritis. “This is a promising strategy, unlike anything we have today. Instead of acting directly on inflammation with immunosuppressive drugs, it regulates the nervous system to balance the immune response.”observes Anna Sylvia Reis, who is currently president of the Goiás Society of Rheumatology.
However, it is not yet time to face neuromodulation as a definitive substitute for the drugs today. “I see, for now, as a complementary option. Medicine is increasingly moving towards individualized treatments, and perhaps, in the future, some patients can benefit only from this technology. But the established treatments are still fundamental, with proven effectiveness and broad experience of use.”says the expert.
Prevention
Like most diseases, the prevention of rheumatoid arthritis undergoes lifestyle choices. Smoking is one of the main risk factors already proven in studies. Therefore, stopping smoking is an essential measure to minimize the risk of the disease. In addition, maintaining proper weight, practicing regular physical activity and adopting a balanced diet are also measures that contribute both to decrease risk and to control inflammation in those who already live with the condition.
In Brazil, there is no forecast of arrival of the newly approved implant in the US. The product would need to go through the evaluation of ANVISA (National Health Surveillance Agency) and cost-effectiveness studies before being incorporated into the health system. “The process usually takes a few years, but I believe that, especially in reference centers, this possibility becomes real in the near future”evaluates the doctor of Einstein.
With information from
