https://doi.org/10.55788/e0f5c3ad
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.
- 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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Table of Contents: ACR 2024
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