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  • DHaens, GeertAmsterdam UMC, Netherlands; Amsterdam Univ Med Ctr, Netherlands (författare)

Neuroimmune Modulation Through Vagus Nerve Stimulation Reduces Inflammatory Activity in Crohns Disease Patients: A Prospective Open-label Study

  • Artikel/kapitelEngelska2023

Förlag, utgivningsår, omfång ...

  • OXFORD UNIV PRESS,2023
  • electronicrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:liu-199742
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-199742URI
  • https://doi.org/10.1093/ecco-jcc/jjad151DOI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:154360324URI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Funding Agencies|SetPoint Medical, Inc.
  • Background and Aims Crohns disease [CD] is a debilitating, inflammatory condition affecting the gastrointestinal tract. There is no cure and sustained clinical and endoscopic remission is achieved by fewer than half of patients with current therapies. The immunoregulatory function of the vagus nerve, the inflammatory reflex, has been established in patients with rheumatoid arthritis and biologic-naive CD. The aim of this study was to explore the safety and efficacy of vagus nerve stimulation in patients with treatment-refractory CD, in a 16-week, open-label, multicentre, clinical trial.Methods A vagus nerve stimulator was implanted in 17 biologic drug-refractory patients with moderately to severely active CD. One patient exited the study pre-treatment, and 16 patients were treated with vagus nerve stimulation [4/16 receiving concomitant biologics] during 16 weeks of induction and 24 months of maintenance treatment. Endpoints included clinical improvement, patient-reported outcomes, objective measures of inflammation [endoscopic/molecular], and safety.Results There was a statistically significant and clinically meaningful decrease in CD Activity Index at Week 16 [mean +/- SD: -86.2 +/- 92.8, p = 0.003], a significant decrease in faecal calprotectin [-2923 +/- 4104, p = 0.015], a decrease in mucosal inflammation in 11/15 patients with paired endoscopies [-2.1 +/- 1.7, p = 0.23], and a decrease in serum tumour necrosis factor and interferon-gamma [46-52%]. Two quality-of-life indices improved in 7/11 patients treated without biologics. There was one study-related severe adverse event: a postoperative infection requiring device explantation.Conclusions Neuroimmune modulation via vagus nerve stimulation was generally safe and well tolerated, with a clinically meaningful reduction in clinical disease activity associated with endoscopic improvement, reduced levels of faecal calprotectin and serum cytokines, and improved quality of life. Graphical Abstract

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Eberhardson, MichaelLinköpings universitet,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Mag- tarmmedicinska kliniken,Karolinska Inst, Sweden(Swepub:liu)miceb31 (författare)
  • Cabrijan, ZeljkoUniv Hosp Dubrava, Croatia; Univ Appl Hlth Sci, Croatia; Josip Juraj Strossmayer Univ Osijek, Croatia (författare)
  • Danese, SilvioIRCCS Osped San Raffaele, Italy; Univ Vita Salute, Italy (författare)
  • van den Berg, RemcoAmsterdam UMC, Netherlands (författare)
  • Lowenberg, MarkAmsterdam UMC, Netherlands (författare)
  • Fiorino, GionataUniv Vita Salute San Raffaele, Italy; San Camillo Forlanini Hosp, Italy (författare)
  • Schuurman, P. RichardAmsterdam UMC, Netherlands (författare)
  • Lind, GoranKarolinska Inst, Sweden; Karolinska Univ Hosp, Sweden (författare)
  • Almqvist, PerKarolinska Inst, Sweden; Karolinska Univ Hosp, Sweden; BioArct Neurosci AB, Sweden (författare)
  • Olofsson, Peder S.Karolinska Univ Hosp, Sweden (författare)
  • Tracey, Kevin J.Feinstein Inst Med Res, NY USA; Donald & Barbara Zucker Sch Med Hofstra Northwell, NY USA; Barbara & Donald Zucker Sch Med Hofstra Northwell, NY 11549 USA (författare)
  • Hanauer, Stephen B.Feinstein Inst Med Res, NY USA; Northwestern Univ, IL USA (författare)
  • Zitnik, RalphSetPoint Med, CA USA; Valerio Consulting, CA USA (författare)
  • Chernoff, DavidSetPoint Med, CA USA (författare)
  • Levine, Yaakov A.Karolinska Institutet (författare)
  • Amsterdam UMC, Netherlands; Amsterdam Univ Med Ctr, NetherlandsAvdelningen för diagnostik och specialistmedicin (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:Journal of Crohn's & Colitis: OXFORD UNIV PRESS17:12, s. 1897-19091873-99461876-4479

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