FDA Approves Implantable Device to Treat RA Patients

SetPoint System, a neuroimmune modulation device, has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response or intolerance to one or more biological or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs). The SetPoint System consists of a neurostimulation device surgically placed under general anesthesia on the vagus nerve to deliver electrical stimulation to the nerve. The treatment is expected to reduce inflammation and restore the immune pathways believed to be dysfunctional in RA patients.

Approval was based on data from the randomized, double-blind, sham-controlled, Phase III REST-RA trial, which included 242 patients, 60 percent of whom had difficult-to-treat RA. All participants were implanted with the study device and then randomly assigned to receive either active stimulation (treatment group) or non-active stimulation (control group). Stimulation was delivered for one minute once per day for 12 weeks. 

Findings showed a significantly greater proportion of patients in the treatment group achieved the primary endpoint of American College of Rheumatology (ACR) 20 response at week 12 compared with the control group (35.2 percent vs. 24.2 percent, respectively; treatment difference, 11 percent). Among patients with exposure to one prior b/tsDMARD (39 percent of the study population), ACR20 response was achieved by 44.2 percent of the treatment group vs. 19 percent of the control group (treatment difference, 25.2 percent). Improvement in disease activity score (DAS28-CRP; secondary endpoint) was also observed with SetPoint, with more patients in the treatment group achieving low disease activity or remission (DAS28-CRP ≤3.2) compared with the control group at week 12. 

At the end of the primary efficacy period, all participants received stimulation with the SetPoint device to assess long-term safety and effectiveness. Results showed 51.5 percent of the treatment group and 53.1 percent of the crossover group (those previously in the control group) had achieved ACR20 response and were free of added b/tsDMARDs at 24 weeks.

“The approval of the SetPoint System highlights the potential of neuroimmune modulation as a novel approach for autoimmune disease by harnessing the body’s neural pathways to combat inflammation,” said Mark Richardson, MD, PhD, director of functional neurosurgery at Massachusetts General Hospital, professor of neurosciences at Harvard Medical School and national surgical principal investigator in the RESET-RA study. “After implantation during a minimally invasive outpatient procedure, the SetPoint device is programmed to automatically administer therapy on a predetermined schedule for up to 10 years, simplifying care for people living with RA.”