A Novel Device for Rheumatoid Arthritis

Clinical Takeaway

: In a sham-controlled study that led to FDA approval, a vagus nerve stimulator modestly improved RA symptoms.

Context

In July 2025, the U.S. FDA approved a vagus nerve stimulator for treating moderate to severe rheumatoid arthritis (RA) in patients with inadequate response or intolerance to at least one biologic or targeted synthetic disease-modifying antirheumatic drug (DMARD). Approval was based on a randomized trial involving 240 such patients who had the stimulator or a sham device implanted near the cervical vagus nerve. Now, investigators have published the results of that trial.

Key Results

The primary outcome was at least a 20% improvement on a standardized scale that assesses joint inflammation, pain, function, and inflammatory markers. At 3 months, 35% of the stimulation group achieved this outcome, compared with 24% of the control group, a …

Reviewing Author

Brett Dietz, M.D., M.S.

Guest Author

Dr. Dietz is Assistant Professor of Medicine at University of California San Francisco and a practicing rheumatologist with the San Francisco VA Health Care System.