September 2026

RHEUMATOLOGY

WHAT DO RESET-RA TRIAL FINDINGS TELL US ABOUT VNS FOR RA? Q&A WITH ERIC RUDERMAN, MD

Key Takeaways
  • The randomized, sham-controlled trial met its primary endpoint, but the difference in ACR20 response was modest.
  • Swollen joint counts provided an objective signal of improvement during the blinded phase.
  • MRI findings were of interest but should not be interpreted as proof of reduced radiographic progression.
  • Findings after three months came from the open-label extension and require more cautious interpretation.
 
Who was studied?
The trial enrolled 240 patients with active, longstanding RA. Mean disease duration was approximately 12.5 years, and 60% of participants had previously received at least two biologic or targeted therapies. This was a treatment-experienced population with active clinical disease.
 
Did the study meet its primary endpoint?
Yes. At three months, the trial demonstrated a statistically significant improvement in ACR20 response rates with active stimulation compared with sham stimulation. The difference was not as large as rheumatologists may be accustomed to seeing in some biologic trials, but it did demonstrate a treatment effect.
 
Were there objective signs of improvement?
Swollen joint counts improved during the blinded phase. That matters because swollen joints are assessed by the clinician and provide a more objective signal than outcomes that rely heavily on patient reports.
 
How should rheumatologists interpret the MRI findings?
MRI analyses suggested improvement among patients with baseline synovitis. However, these findings are not the same as demonstrating reduced radiographic progression.
The blinded comparison lasted only three months, and additional studies will be needed to determine whether the imaging changes translate into meaningful long-term protection against structural damage.
 
What should we make of the longer-term results?
After three months, all participants could receive active stimulation and could add biologic or targeted therapy. Any additional improvement during that period comes from an open-label extension, so it is difficult to separate the effect of stimulation from treatment expectations or concomitant medications. The longer-term findings are encouraging, but they should be viewed with caution.
 
What was Northwestern Medicine's role?
Northwestern Medicine participated as a study site in the randomized trial. That experience also provides a foundation for understanding the clinical, surgical and operational questions that accompany an implantable therapy.
Eric M. Ruderman, MD, Professor of Rheumatology at Northwestern Medicine​

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