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Positive results for vagus nerve stimulation in RA

Presented by
Dr John Tesser, Arizona Arthritis & Rheumatology Associates, AZ, USA
Conference
ACR 2024
Trial
Phase 3, RESET-RA
Doi
https://doi.org/10.55788/e0f5c3ad
The phase 3 RESET-RA study found that neuroimmune modulation using an implantable vagus nerve stimulation (VNS) device was effective and well-tolerated among adults with active RA and inadequate response or intolerance to at least one biological (b)DMARD or targeted-synthetic (ts)DMARD.

The double-blind, randomised-controlled, phase 3 RESET-RA study (NCT04539964) evaluated the safety and efficacy of VNS in patients with moderate-to-severe RA [1]. The 242 enrolled participants had previously failed treatment with at least 1 b/tsDMARD and remained on stable background conventional DMARDs. Their mean age was 56 years, 86% were women, and the mean RA duration was 12 years. Participants were randomised 1:1 to active or non-active (control) stimulation. The primary endpoint was ACR20 response at 12 weeks. At that time, the study changed to an open-label design, allowing the control group to cross over to treatment. Efficacy was re-assessed at week 24. The results were presented by Dr John Tesser (Arizona Arthritis & Rheumatology Associates, AZ, USA).

ACR20 response at week 12 was significantly higher in the treatment group: 35.2% versus 24.2% in controls (Δ11%; 95% CI 0.6–23.1; P=0.0209). In a prespecified analysis, ACR20 response at week 12 for participants exposed to 1 prior bDMARD was 44.2% and 19.0%, respectively (Δ25.2%; 95% CI 7.1–43.3; P=0.0054). All secondary and exploratory endpoints trended in favour of the treatment group.

After crossover, at week 24, ACR20 response rates had further increased to 51.5% and 53.1% in the treatment and control groups, respectively. By that time, 81% of the participants were on VNS therapy alone and free of added b/tsDMARD. Overall, the safety profile was acceptable. Stimulation therapy specifically was well-tolerated. The most frequently reported treatment-related adverse event was mild-to-moderate hoarseness/vocal cord dysfunction. The rate of serious adverse events was 1.7% in the treatment group. Further replication studies are needed; studies in early RA will also be useful to determine whether it is the impact on inflammation or on post-inflammatory pain that may influence the ACR responses.

  1. Tesser J, et al. Neuroimmune modulation in adults with rheumatoid arthritis and inadequate response or intolerance to biological or targeted synthetic DMARDs: Results at 12 and 24 weeks from a randomized, sham-controlled, double-blind pivotal study. Abstract L10, ACR Convergence 2024, 14–19 November, Washington DC, USA.

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