Positive results for vagus nerve stimulation in RA

In the randomised, double-blind, sham-controlled RESET-RA study, neuroimmune modulation using an implantable vagus nerve stimulation (VNS) device was effective among adults with active rheumatoid arthritis (RA) and inadequate response or intolerance to at least one biological DMARD (bDMARD) or targeted-synthetic DMARD (tsDMARD). The treatment was also well tolerated.

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

ACR20 response at week 12 was significantly higher in the treatment group (35.2% vs 24.2% in controls; Δ11%; 95% CI 0.6–23.1; P=0.0209). In a prespecified analysis, ACR20 response at week 12 for patients with exposure 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 further increased to 51.5% and 53.1% in the treatment and control group, 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.

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.

 

Medical writing support was provided by Michiel Tent

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Posted on 22 November 202422 November 2024