Vagus nerve-mediated neuroimmune modulation for rheumatoid arthritis: a pivotal randomized controlled trial

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Source: Nature Medicine

Original: https://www.nature.com/articles/s41591-025-04114-7...

Published: 2025-12-22

An implantable vagus nerve stimulating device safely reduces rheumatoid arthritis activity and joint damage in patients who do not respond to or tolerate medications.[The RESET-RA study was the pivotal randomized controlled trial that demonstrated significant improvement in disease activity with active stimulation versus a no stimulation group.1[1][6] The SetPoint System device activates neuroimmune pathways to reduce inflammation, and is FDA-approved for adults with moderate-to-severe rheumatoid arthritis.[5][6][8] In a pilot study, 50% of patients with drug-unresponsive rheumatoid arthritis improved clinically, two achieved remission, and pro-inflammatory cytokines decreased by 30-50% with daily stimulation.2 In a 36-month extension study (14 patients after failure of at least two biologic medications), stimulation was well tolerated and reductions in disease activity were sustained.[2][3] The device is implanted in the neck, stimulates the vagus nerve for about 1 minute per day, and the battery is recharged weekly.[4][5] Minimal side effects have occurred, with only 1.7% of serious cases.[5] It offers a non-drug treatment without the systemic effects of medications.