Vagal Nerve Stimulation in Rheumatoid Arthritis Save
Lancet Rheumatology has reported the results of a proof of concept trial, wherein vagal nerve stimulation was shown to ameliorate rheumatoid arthritis (RA) disease activity.
The intervention involved non-invasive stimulation of the auricular branch of the vagus nerve using a wearable vagus nerve stimulation device for up to 30 min per day, delivering pulses of 20 kHz. Prior studies have shown this intervention to inhibit TNF signaling.
The study was a prospective, multicentre, open-label, single-arm trial that enrolled 35 adult patients with active RA unresponsive to a conventional DMARDs and and up to one biological DMARD. The primary endpoint was the mean change in Disease Activity Score of 28 joints with C-reactive protein (DAS28-CRP) at week 12.
Of the 35 patients screened, 30 were enrolled and 27 (90%) completed the week 12 visit.
The baseline DAS28-CRP was 5·3 (SD 1·0) and the mean change at 12 weeks was −1·4 (95%CI −1·9 to −0·9; p<0·0001) .
By week 12, 37% achieved a DAS28-CRP of 3·2 or less, and 23% patients reached DAS28-CRP of less than 2·6.
The mean HAQ-DI change was −0·5 (95%CI −0·7 to −0·2; p<0·0001) and 57% achieved minimal clinically important difference of 0·22 or more.
ACR20 response was 53%, ACR50 was 33% and the ACR70 was 17%. There were no serious adverse events and no deaths.
Further, larger, controlled studies are planned.