#United States #Santa Clarita #rheumatoid arthritis #SetPoint Medical #Neuroimmune Modulation

SetPoint Medical's Long-Term Data on Rheumatoid Arthritis Treatment

SetPoint Medical has recently unveiled impactful data from its 24-month follow-up period related to the SetPoint® System therapy for rheumatoid arthritis (RA). The findings, shared at the ACR Convergence 2026 conference, emphasize the system's potential to offer significant and lasting improvements for patients grappling with this chronic autoimmune condition.

SetPoint Medical thrives on innovation in treating chronic autoimmune diseases. The company's pivotal RESET-RA trial validates its foundational premise: that neuroimmune modulation can serve as a durable treatment option for RA patients. This therapy is the first of its kind to receive FDA approval specifically for rheumatoid arthritis, paving the way for new possibilities in patient care.

In this comprehensive study, 242 adults suffering from moderately to severely active RA participated after experiencing inadequate responses to previously attempted biologics or targeted synthetic drugs. The results were notably encouraging, as 71% of participants maintained their treatment outcomes over two years without the need to rely on additional biologic medications or targeted b/tsDMARDs.

Sustained Improvements Over 24 Months

According to studies presented by Dr. John R.P. Tesser, the clinical efficacy of the SetPoint therapy exhibited remarkable durability. Notably, response rates improved over the study period, with 62.7% of the participants achieving a 20% improvement in their overall condition (ACR20), 38.7% showing a 50% improvement (ACR50), and 18.7% achieving a 70% improvement (ACR70). These statistics reinforce the therapy’s effectiveness over the course of treatment.

Moreover, the long-term results indicated a significant drop in disease activity, with about half of the patients reaching low disease activity or remission. This was assessed using both the Disease Activity Score in 28 joints (DAS28-CRP) and the Clinical Disease Activity Index (CDAI). An impressive 77.7% of the participants recorded good or moderate responses based on the DAS28-CRP metrics.

High Persistence Rate and Minimal Side Effects

The long-term study results also highlighted a dispiriting persistence rate among participants; 91.7% continued with the stimulation therapy throughout the 24 months. Only a small fraction, about 29.3%, required the addition of b/tsDMARDs during this timeframe. Notably, among the 242 participants, only 14 underwent device removal, citing a lack of efficacy as the primary reason.

Safety was another significant aspect of the study, with no severe adverse events reported in relation to the device or the stimulation therapy throughout the follow-up. Most of the adverse reactions documented were mild to moderate pain at the implant site, which resolved either spontaneously or with minor adjustments to the stimulation parameters.

What This Means for Rheumatoid Arthritis Patients

Dr. David Chernoff, Chief Medical Officer of SetPoint Medical, emphasized the importance of innovative treatment options for managing rheumatoid arthritis effectively over the long term. The promising results showcase the potential of SetPoint’s neuroimmune modulation therapy as an alternative approach for patients who may not respond to or tolerate existing therapies.

Murthy V. Simhambhatla, CEO of SetPoint Medical, conveyed optimism regarding the findings and the opportunity to expand patient access nationwide. The positive outcomes reinforce the role of the SetPoint System as a critical part of RA management, especially for those inadequately treated by traditional medications.

Further studies will continue to explore the implications of this therapy, with plans to investigate its application for additional conditions such as multiple sclerosis and Crohn's disease, demonstrating SetPoint's commitment to revolutionizing treatment for autoimmune diseases.

For those living with rheumatoid arthritis, SetPoint Medical offers hope for a better quality of life through innovative therapeutic solutions that address their unique healthcare needs.