SetPoint Medical has released new findings from its RESET-RA study, presented at the American College of Rheumatology (ACR) Convergence 2024. The study highlights the potential of the SetPoint System, a neuroimmune modulation treatment, for adults with moderate-to-severe rheumatoid arthritis (RA). This therapy is designed for those who have not responded to, or cannot tolerate, at least one biologic or targeted synthetic disease-modifying anti-rheumatic drug (b/tsDMARD).

The study enrolled 242 participants and met its primary efficacy goal, achieving a significant ACR20 response rate. This measure, established by the American College of Rheumatology, evaluates the effectiveness of RA treatments.

Participants in the study represented a typical RA population, with over 60% experiencing difficult-to-treat disease after trying two or more b/tsDMARDs. By 12 weeks, 35.2% of patients receiving SetPoint therapy achieved an ACR20 response compared to 24.2% in the control group. After the 12-week mark, all participants switched to SetPoint therapy. By 24 weeks, ACR20 response rates increased to 51.5% in the original treatment group and 53.1% in the crossover group.

Subgroup analysis showed notable improvements, with 44.2% of those who had tried only one prior b/tsDMARD achieving an ACR20 response, compared to 19.0% in the control group. Further improvements were observed in Disease Activity Scores (DAS28-CRP), with more patients reaching low disease activity or remission by 12 weeks. MRI scans also indicated reduced progression of bone erosion among patients treated with SetPoint therapy, particularly in those with a highly erosive disease or limited previous treatment options.

The treatment demonstrated a favourable safety profile, with a low rate of serious adverse events (1.7%) during the first 12 weeks and no additional serious incidents reported through week 24. Mild to moderate hoarseness, associated with the implantation procedure near the vagus nerve, was the most common side effect. No participants withdrew from the study due to adverse events, and no deaths were reported.

The SetPoint System is an implantable, rechargeable device designed to stimulate the vagus nerve, activating natural anti-inflammatory pathways. The goal is to manage RA symptoms without the risks linked to immunosuppressive medications. Once implanted in an outpatient procedure, the device is programmed for daily stimulation, ensuring consistency in therapy.

The RESET-RA study demonstrates the potential of neuroimmune modulation as a novel approach to treating RA, especially for patients who face challenges with current therapies. Further studies are planned to evaluate the long-term safety and effectiveness of the treatment.



Source: setpointmedical.com

Report Abuse