Vagus nerve stimulation (VNS) using a miniaturised device is a potential alternative approach in patients with rheumatoid arthritis, particularly for those who are refractory to biological treatments and Janus kinase inhibitor therapies, according to a clinical trial published in Lancet Rheumatology.
This first-in-human, 2-stage pilot study enrolled 14 patients with moderately to severely active rheumatoid arthritis and prior insufficient response to two or more biological disease-modifying anti-rheumatic drugs or Janus kinase inhibitors. Stage 1 was open-label and 3 participants were implanted with a miniaturised VNS device. In stage 2, the remaining 11 participants were randomly assigned to receive active stimulation or sham stimulation (device implanted but not activated).
The primary outcome was the incidence of treatment-emergent adverse events, and clinical efficacy was assessed as a key secondary outcome.
There were no device-related or treatment-related serious adverse events. Five of ten patients who received active stimulation showed clinical improvement, both in terms of 28-joint disease activity score and clinical disease activity index.
The authors concluded that the use of an implantable miniaturised VNS device to activate the cholinergic anti-inflammatory pathway was safe, well-tolerated, and showed clinical and biomarker efficacy in a group of patients with multidrug-refractory rheumatoid arthritis.