A Randomized, Double‐Blind, Sham‐Controlled, Clinical Trial of Auricular Vagus Nerve Stimulation for the Treatment of Active Rheumatoid Arthritis
Objective Preliminary evidence suggests that vagus nerve stimulation (VNS) may have some benefit in patients with rheumatoid arthritis (RA); however, prior studies have been small and/or uncontrolled; this study aimed to address that gap. Methods This randomized, double‐blind, sham‐controlled trial...
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| Veröffentlicht in: | Arthritis & rheumatology (Hoboken, N.J.) N.J.), 2023-12, Vol.75 (12), p.2107-2115 |
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| creator | Baker, Matthew C. Kavanagh, Sarah Cohen, Stanley Matsumoto, Alan K. Dikranian, Ara Tesser, John Kivitz, Alan Alataris, Konstantinos Genovese, Mark C. |
| description | Objective
Preliminary evidence suggests that vagus nerve stimulation (VNS) may have some benefit in patients with rheumatoid arthritis (RA); however, prior studies have been small and/or uncontrolled; this study aimed to address that gap.
Methods
This randomized, double‐blind, sham‐controlled trial enrolled patients aged 18 to 75 years with active RA who had failed conventional synthetic disease‐modifying antirheumatic drugs (DMARDs) and were naïve to biologic and/or targeted synthetic DMARDs. All patients received an auricular vagus nerve stimulator and were randomized 1:1 to active stimulation or sham. The primary endpoint was the proportion of patients achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 12. Secondary endpoints included mean changes in disease activity score of 28 joints with C‐reactive protein (DAS28‐CRP) and Health Assessment Questionnaire‐Disability Index (HAQ‐DI).
Results
A total of 113 patients (mean age 54 years; 82% female) enrolled, and 101 patients (89.4%) completed week 12. ACR20 response at week 12 was 25.0% for active stimulation versus 26.9% for sham (difference vs. sham, −1.9; 95% CI, −18.8, 14.9, P = 0.823). The least square mean ± SE change in DAS28‐CRP was −0.95 ± 0.16 for active stimulation and −0.66 ± 0.16 for sham (P = 0.201); in HAQ‐DI it was −0.19 ± 0.06 for active stimulation and −0.02 ± 0.06 for sham (P = 0.044). Adverse events occurred in 17 patients (15%); all were mild or moderate.
Conclusion
Auricular VNS did not meaningfully improve RA disease activity. If VNS with other modalities is pursued in the future for the treatment of RA, larger, controlled studies will be needed to understand its utility. |
| doi_str_mv | 10.1002/art.42637 |
| format | Article |
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Preliminary evidence suggests that vagus nerve stimulation (VNS) may have some benefit in patients with rheumatoid arthritis (RA); however, prior studies have been small and/or uncontrolled; this study aimed to address that gap.
Methods
This randomized, double‐blind, sham‐controlled trial enrolled patients aged 18 to 75 years with active RA who had failed conventional synthetic disease‐modifying antirheumatic drugs (DMARDs) and were naïve to biologic and/or targeted synthetic DMARDs. All patients received an auricular vagus nerve stimulator and were randomized 1:1 to active stimulation or sham. The primary endpoint was the proportion of patients achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 12. Secondary endpoints included mean changes in disease activity score of 28 joints with C‐reactive protein (DAS28‐CRP) and Health Assessment Questionnaire‐Disability Index (HAQ‐DI).
Results
A total of 113 patients (mean age 54 years; 82% female) enrolled, and 101 patients (89.4%) completed week 12. ACR20 response at week 12 was 25.0% for active stimulation versus 26.9% for sham (difference vs. sham, −1.9; 95% CI, −18.8, 14.9, P = 0.823). The least square mean ± SE change in DAS28‐CRP was −0.95 ± 0.16 for active stimulation and −0.66 ± 0.16 for sham (P = 0.201); in HAQ‐DI it was −0.19 ± 0.06 for active stimulation and −0.02 ± 0.06 for sham (P = 0.044). Adverse events occurred in 17 patients (15%); all were mild or moderate.
Conclusion
Auricular VNS did not meaningfully improve RA disease activity. If VNS with other modalities is pursued in the future for the treatment of RA, larger, controlled studies will be needed to understand its utility.</description><identifier>ISSN: 2326-5191</identifier><identifier>EISSN: 2326-5205</identifier><identifier>DOI: 10.1002/art.42637</identifier><identifier>PMID: 37390360</identifier><language>eng</language><publisher>Boston, USA: Wiley Periodicals, Inc</publisher><subject>Adolescent ; Adult ; Aged ; Antirheumatic Agents - therapeutic use ; Arthritis ; Arthritis, Rheumatoid - drug therapy ; Autoimmune diseases ; C-Reactive Protein ; Double-Blind Method ; Female ; Health services ; Humans ; Joint diseases ; Male ; Middle Aged ; Nerves ; Patients ; Rheumatoid arthritis ; Rheumatology ; Stimulation ; Stimulators ; Treatment Outcome ; Vagus nerve ; Vagus Nerve Stimulation ; Young Adult</subject><ispartof>Arthritis & rheumatology (Hoboken, N.J.), 2023-12, Vol.75 (12), p.2107-2115</ispartof><rights>2023 American College of Rheumatology</rights><rights>2023 American College of Rheumatology.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3537-4e24868d81cc4ebe093026ae89fb40b63be15d7acda68b3360aaffdf2236a57e3</citedby><cites>FETCH-LOGICAL-c3537-4e24868d81cc4ebe093026ae89fb40b63be15d7acda68b3360aaffdf2236a57e3</cites><orcidid>0000-0002-0002-1907 ; 0000-0002-9226-979X ; 0000-0001-5294-4503</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fart.42637$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fart.42637$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37390360$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Baker, Matthew C.</creatorcontrib><creatorcontrib>Kavanagh, Sarah</creatorcontrib><creatorcontrib>Cohen, Stanley</creatorcontrib><creatorcontrib>Matsumoto, Alan K.</creatorcontrib><creatorcontrib>Dikranian, Ara</creatorcontrib><creatorcontrib>Tesser, John</creatorcontrib><creatorcontrib>Kivitz, Alan</creatorcontrib><creatorcontrib>Alataris, Konstantinos</creatorcontrib><creatorcontrib>Genovese, Mark C.</creatorcontrib><title>A Randomized, Double‐Blind, Sham‐Controlled, Clinical Trial of Auricular Vagus Nerve Stimulation for the Treatment of Active Rheumatoid Arthritis</title><title>Arthritis & rheumatology (Hoboken, N.J.)</title><addtitle>Arthritis Rheumatol</addtitle><description>Objective
Preliminary evidence suggests that vagus nerve stimulation (VNS) may have some benefit in patients with rheumatoid arthritis (RA); however, prior studies have been small and/or uncontrolled; this study aimed to address that gap.
Methods
This randomized, double‐blind, sham‐controlled trial enrolled patients aged 18 to 75 years with active RA who had failed conventional synthetic disease‐modifying antirheumatic drugs (DMARDs) and were naïve to biologic and/or targeted synthetic DMARDs. All patients received an auricular vagus nerve stimulator and were randomized 1:1 to active stimulation or sham. The primary endpoint was the proportion of patients achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 12. Secondary endpoints included mean changes in disease activity score of 28 joints with C‐reactive protein (DAS28‐CRP) and Health Assessment Questionnaire‐Disability Index (HAQ‐DI).
Results
A total of 113 patients (mean age 54 years; 82% female) enrolled, and 101 patients (89.4%) completed week 12. ACR20 response at week 12 was 25.0% for active stimulation versus 26.9% for sham (difference vs. sham, −1.9; 95% CI, −18.8, 14.9, P = 0.823). The least square mean ± SE change in DAS28‐CRP was −0.95 ± 0.16 for active stimulation and −0.66 ± 0.16 for sham (P = 0.201); in HAQ‐DI it was −0.19 ± 0.06 for active stimulation and −0.02 ± 0.06 for sham (P = 0.044). Adverse events occurred in 17 patients (15%); all were mild or moderate.
Conclusion
Auricular VNS did not meaningfully improve RA disease activity. If VNS with other modalities is pursued in the future for the treatment of RA, larger, controlled studies will be needed to understand its utility.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Antirheumatic Agents - therapeutic use</subject><subject>Arthritis</subject><subject>Arthritis, Rheumatoid - drug therapy</subject><subject>Autoimmune diseases</subject><subject>C-Reactive Protein</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Health services</subject><subject>Humans</subject><subject>Joint diseases</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Nerves</subject><subject>Patients</subject><subject>Rheumatoid arthritis</subject><subject>Rheumatology</subject><subject>Stimulation</subject><subject>Stimulators</subject><subject>Treatment Outcome</subject><subject>Vagus nerve</subject><subject>Vagus Nerve Stimulation</subject><subject>Young Adult</subject><issn>2326-5191</issn><issn>2326-5205</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc1u1DAQxy1ERau2B14AWeICEts6dmInx7B8VapaabtwjSbOhHXlxK0_QOXEI3DhBXkS3G7LoRJz8HhmfvOXrT8hzwt2VDDGj8HHo5JLoZ6QPS64XFScVU8f7kVT7JLDEC5ZjkYxyapnZFco0TAh2R753dIVzIObzA8c3tB3LvUW__z89daaOdcXG5hytXRz9M7aW2SZJ0aDpWtv8ulG2iZvdLLg6Rf4mgI9Q_8N6UU0U25G42Y6Ok_jBvMKQpxwjndrOprMrTaYJojODLT1ceNNNOGA7IxgAx7e533y-cP79fLT4vT848myPV1oUQm1KJGXtayHutC6xB5ZIxiXgHUz9iXrpeixqAYFegBZ9yJ_GGAch5FzIaFSKPbJq63ulXfXCUPsJhM0WgszuhQ6XgteKc6ZzOjLR-ilS37Or8tUU8paVarI1Ostpb0LwePYXXkzgb_pCtbd2tVlu7o7uzL74l4x9RMO_8gHczJwvAW-G4s3_1fq2tV6K_kX9oGhfQ</recordid><startdate>202312</startdate><enddate>202312</enddate><creator>Baker, Matthew C.</creator><creator>Kavanagh, Sarah</creator><creator>Cohen, Stanley</creator><creator>Matsumoto, Alan K.</creator><creator>Dikranian, Ara</creator><creator>Tesser, John</creator><creator>Kivitz, Alan</creator><creator>Alataris, Konstantinos</creator><creator>Genovese, Mark C.</creator><general>Wiley Periodicals, Inc</general><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7QP</scope><scope>7T5</scope><scope>7TM</scope><scope>7U7</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-0002-1907</orcidid><orcidid>https://orcid.org/0000-0002-9226-979X</orcidid><orcidid>https://orcid.org/0000-0001-5294-4503</orcidid></search><sort><creationdate>202312</creationdate><title>A Randomized, Double‐Blind, Sham‐Controlled, Clinical Trial of Auricular Vagus Nerve Stimulation for the Treatment of Active Rheumatoid Arthritis</title><author>Baker, Matthew C. ; Kavanagh, Sarah ; Cohen, Stanley ; Matsumoto, Alan K. ; Dikranian, Ara ; Tesser, John ; Kivitz, Alan ; Alataris, Konstantinos ; Genovese, Mark C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3537-4e24868d81cc4ebe093026ae89fb40b63be15d7acda68b3360aaffdf2236a57e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Antirheumatic Agents - therapeutic use</topic><topic>Arthritis</topic><topic>Arthritis, Rheumatoid - drug therapy</topic><topic>Autoimmune diseases</topic><topic>C-Reactive Protein</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Health services</topic><topic>Humans</topic><topic>Joint diseases</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Nerves</topic><topic>Patients</topic><topic>Rheumatoid arthritis</topic><topic>Rheumatology</topic><topic>Stimulation</topic><topic>Stimulators</topic><topic>Treatment Outcome</topic><topic>Vagus nerve</topic><topic>Vagus Nerve Stimulation</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Baker, Matthew C.</creatorcontrib><creatorcontrib>Kavanagh, Sarah</creatorcontrib><creatorcontrib>Cohen, Stanley</creatorcontrib><creatorcontrib>Matsumoto, Alan K.</creatorcontrib><creatorcontrib>Dikranian, Ara</creatorcontrib><creatorcontrib>Tesser, John</creatorcontrib><creatorcontrib>Kivitz, Alan</creatorcontrib><creatorcontrib>Alataris, Konstantinos</creatorcontrib><creatorcontrib>Genovese, Mark C.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Arthritis & rheumatology (Hoboken, N.J.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Baker, Matthew C.</au><au>Kavanagh, Sarah</au><au>Cohen, Stanley</au><au>Matsumoto, Alan K.</au><au>Dikranian, Ara</au><au>Tesser, John</au><au>Kivitz, Alan</au><au>Alataris, Konstantinos</au><au>Genovese, Mark C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Randomized, Double‐Blind, Sham‐Controlled, Clinical Trial of Auricular Vagus Nerve Stimulation for the Treatment of Active Rheumatoid Arthritis</atitle><jtitle>Arthritis & rheumatology (Hoboken, N.J.)</jtitle><addtitle>Arthritis Rheumatol</addtitle><date>2023-12</date><risdate>2023</risdate><volume>75</volume><issue>12</issue><spage>2107</spage><epage>2115</epage><pages>2107-2115</pages><issn>2326-5191</issn><eissn>2326-5205</eissn><abstract>Objective
Preliminary evidence suggests that vagus nerve stimulation (VNS) may have some benefit in patients with rheumatoid arthritis (RA); however, prior studies have been small and/or uncontrolled; this study aimed to address that gap.
Methods
This randomized, double‐blind, sham‐controlled trial enrolled patients aged 18 to 75 years with active RA who had failed conventional synthetic disease‐modifying antirheumatic drugs (DMARDs) and were naïve to biologic and/or targeted synthetic DMARDs. All patients received an auricular vagus nerve stimulator and were randomized 1:1 to active stimulation or sham. The primary endpoint was the proportion of patients achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 12. Secondary endpoints included mean changes in disease activity score of 28 joints with C‐reactive protein (DAS28‐CRP) and Health Assessment Questionnaire‐Disability Index (HAQ‐DI).
Results
A total of 113 patients (mean age 54 years; 82% female) enrolled, and 101 patients (89.4%) completed week 12. ACR20 response at week 12 was 25.0% for active stimulation versus 26.9% for sham (difference vs. sham, −1.9; 95% CI, −18.8, 14.9, P = 0.823). The least square mean ± SE change in DAS28‐CRP was −0.95 ± 0.16 for active stimulation and −0.66 ± 0.16 for sham (P = 0.201); in HAQ‐DI it was −0.19 ± 0.06 for active stimulation and −0.02 ± 0.06 for sham (P = 0.044). Adverse events occurred in 17 patients (15%); all were mild or moderate.
Conclusion
Auricular VNS did not meaningfully improve RA disease activity. If VNS with other modalities is pursued in the future for the treatment of RA, larger, controlled studies will be needed to understand its utility.</abstract><cop>Boston, USA</cop><pub>Wiley Periodicals, Inc</pub><pmid>37390360</pmid><doi>10.1002/art.42637</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-0002-1907</orcidid><orcidid>https://orcid.org/0000-0002-9226-979X</orcidid><orcidid>https://orcid.org/0000-0001-5294-4503</orcidid></addata></record> |
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| subjects | Adolescent Adult Aged Antirheumatic Agents - therapeutic use Arthritis Arthritis, Rheumatoid - drug therapy Autoimmune diseases C-Reactive Protein Double-Blind Method Female Health services Humans Joint diseases Male Middle Aged Nerves Patients Rheumatoid arthritis Rheumatology Stimulation Stimulators Treatment Outcome Vagus nerve Vagus Nerve Stimulation Young Adult |
| title | A Randomized, Double‐Blind, Sham‐Controlled, Clinical Trial of Auricular Vagus Nerve Stimulation for the Treatment of Active Rheumatoid Arthritis |
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