SetPoint Medical: 92.1% of 242 RA patients stayed on vagus nerve stimulation at 24 months
In SetPoint Medical's open extension study with an implanted stimulator, 62.8% of rheumatoid arthritis patients needed no added b/tsDMARDs after two years.
SetPoint Medical presented long-term data from an open extension study of vagus nerve stimulation in rheumatoid arthritis at the annual meeting of the American College of Rheumatology in Orlando, according to ad-hoc-news.de. The study included 242 patients who had responded inadequately to biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs). Efficacy and tolerability were analysed over two years. ad-hoc-news.de
ad-hoc-news.dead-hoc-news.deOpen source ↗
Stimulation therapy results at 24 months
Treatment used an implanted vagus nerve stimulator that delivers one-minute electrical pulses to the left cervical vagus nerve once a day. After 24 months, 92.1 percent of patients continued the stimulation therapy. At the same point, 62.8 percent needed no additional b/tsDMARD therapy.
Clinical response rates improved step by step. The ACR20 rate was 57.7 percent at 12 months, 62.1 percent at 18 months and 70.9 percent at 24 months. At 24 months, 43.6 percent of participants had an ACR50 improvement and 25.5 percent reached an ACR70 response. By the DAS-28-CRP and CDAI activity indices, more than 50 percent of patients reached low disease activity or remission.
Difficult-to-treat disease and drug risks
Under the EULAR definition, about 12 percent of patients meet the criteria for difficult-to-treat rheumatoid arthritis. ad-hoc-news.de
ad-hoc-news.dead-hoc-news.deOpen source ↗ In the affected synovium, the material describes metabolic abnormalities in glycolysis and lipid metabolism, as well as mitochondrial dysfunction. These reprogrammed pathways influence inflammatory cells and the invasion of synovial fibroblasts. No clinically validated metabolic biomarkers exist yet for selecting therapy.
The report also cites drug-based options. In a 2026 study by Salvato and colleagues, patients with pronounced, biopsy-confirmed synovitis benefited more from JAK inhibitors than from non-TNF inhibitors. A 2024 analysis of 75,000 patients pointed to a higher risk of venous thrombosis, stroke and ischaemic heart disease with JAK inhibitors than with biologics, mainly at high doses or with pre-existing conditions.
