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<p>The inflammatory reflex, in which vagus nerve signaling modulates cytokine production, is dysregulated in rheumatoid arthritis (RA). RESET-RA, a pivotal, double-blind, randomized, sham-controlled trial, evaluated a vagus nerve-targeted neuromodulation system for RA in 242 patients with inadequate response/intolerance to biological/targeted synthetic disease-modifying antirheumatic drugs. Patients were randomized to active or sham stimulation for 3 months, and then all received open-label stimulation with results reported to 12 months. The primary end point was 3-month American College of Rheumatology 20% (ACR20) response. ACR20 rates were higher with active simulation than with sham at 3 months (35.2% versus 24.2%, <i>P</i> = 0.0209), which further improved in open-label to 50.0% at 6 months and 52.8% at 12 months (all-completers). Adverse events occurred in a similar proportion of patients in both arms. Related serious adverse events (rate = 1.6%) were all perioperative, and resolved. Vagus nerve-mediated neuroimmune modulation for RA achieved its primary efficacy end point and produced durable clinical benefits with a favorable safety profile. ClinicalTrials.gov registration: <a href="https://clinicaltrials.gov/study/NCT04539964">NCT04539964</a>.</p>

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Vagus nerve-mediated neuroimmune modulation for rheumatoid arthritis: a pivotal randomized controlled trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月22日

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  • John R. P. Tesser,
  • Angela R. Crowley,
  • Emily Jane Box,
  • Joshua P. June,
  • Pendleton Brewster Wickersham,
  • Guillermo J. Valenzuela,
  • Norman B. Gaylis,
  • Gordon K. W. Lam,
  • Leroy A. Pacheco,
  • David J. Ridley,
  • Gineth Paola Pinto-Patarroyo,
  • Stuart N. Novack,
  • Melvin A. Churchill,
  • Minna Kohler,
  • Eric C. Lee,
  • Jose A. Pando,
  • Glenn R. Parris,
  • Jeff R. Peterson,
  • Tina Shah,
  • Atul K. Singhal,
  • Victoria Vuong,
  • Yaakov A. Levine,
  • Melissa L. Evangelista,
  • Amy A. Derosier,
  • Jeffrey R. Curtis,
  • R. Mark Richardson,
  • David Chernoff

摘要

The inflammatory reflex, in which vagus nerve signaling modulates cytokine production, is dysregulated in rheumatoid arthritis (RA). RESET-RA, a pivotal, double-blind, randomized, sham-controlled trial, evaluated a vagus nerve-targeted neuromodulation system for RA in 242 patients with inadequate response/intolerance to biological/targeted synthetic disease-modifying antirheumatic drugs. Patients were randomized to active or sham stimulation for 3 months, and then all received open-label stimulation with results reported to 12 months. The primary end point was 3-month American College of Rheumatology 20% (ACR20) response. ACR20 rates were higher with active simulation than with sham at 3 months (35.2% versus 24.2%, P = 0.0209), which further improved in open-label to 50.0% at 6 months and 52.8% at 12 months (all-completers). Adverse events occurred in a similar proportion of patients in both arms. Related serious adverse events (rate = 1.6%) were all perioperative, and resolved. Vagus nerve-mediated neuroimmune modulation for RA achieved its primary efficacy end point and produced durable clinical benefits with a favorable safety profile. ClinicalTrials.gov registration: NCT04539964.