Early data offer ‘hopeful’ results for vagus nerve stimulation in rheumatoid arthritis
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SAN DIEGO — Vagus nerve stimulation may represent a “novel therapeutic option” for patients with rheumatoid arthritis, according to data presented at the 2024 Congress of Clinical Rheumatology West.
“The word neuroimmune modulation was picked specifically because you can impact various nerves, including the vagus nerve and splenic nerve, with different kinds of energy,” David N. Chernoff MD, a rheumatologist with SetPoint Medical, in Valencia, California, said in his presentation. “The point of it is to connect what the brain does normally with the immune system and use that in the context of autoinflammatory disease to dampen inflammation.”
During his talk, Chernoff updated attendees on the clinical trial program for SetPoint Medical’s implantable vagus nerve stimulation device for patients with RA.
The initial proof of concept study was conducted among 17 patients in Europe and published in 2016. A feasibility study followed and included 14 patients from four sites across the United States, with findings published in 2020.
All of this led to the RESET RA study.
“The RESET RA study has enrolled 242 patients at these sites,” Chernoff said, noting that more than 40 sites in the United States are participating in the program.
Eligible participants for RESET RA were required to have active RA.
“There is no C-reactive protein requirement,” Chernoff said. “Everybody who is on a drug is washed off of that drug and maintained on background methotrexate, Plaquenil (hydroxychloroquine, Sanofi-Aventis) or sulfasalazine, and is stable for 3 months.”
The vagus nerve stimulation device implant procedure is “about 45 minutes” long and is conducted in an outpatient setting using general anesthesia, according to Chernoff.
After patients healed from the initial procedure, they were randomly assigned to be actively stimulated or sham stimulated for 1 minute per day.
“This does not require much activation energy,” Chernoff said.
Participants were assessed using DAS28 and American College of Rheumatology responses. In addition, all participants underwent a gadolinium MRI scan and an RA MRI Scoring System (RAMRIS) scan.
“After 12 weeks, we repeat the MRI scans, we repeat the biomarkers,” Chernoff said.
At this point, patients who have been in the sham group also undergo active stimulation in an open-label fashion.
Results at 12 weeks showed a difference between the active stimulation and control arms, as assessed by ACR20 response, according to Chernoff. He added that further data will be presented in upcoming conferences.
“Vagus nerve neural mediated modulatory mechanisms have a very important role in mediating inflammatory disease,” Chernoff said. “We are hopeful that this approach of neuroimmune modulation will represent a novel therapeutic option, in addition to all the pharmaceutical drugs we have available.”
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Chernoff DN. Neuroimmune Modulation for the Treatment of Rheumatoid Arthritis. Presented at The Congress of Clinical Rheumatology West; Sept. 26-29, 2024. (hybrid meeting).
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