{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T04:45:53Z","timestamp":1784868353663,"version":"3.55.0"},"reference-count":43,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,1,15]],"date-time":"2025-01-15T00:00:00Z","timestamp":1736899200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>The efficacy of tumor necrosis factor inhibitors for treating chronic low\u2010back pain with Modic changes is uncertain. This study investigated the superiority of infliximab over placebo in patients with Modic type 1 changes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this multicenter, randomized, triple\u2010blind, placebo\u2010controlled trial, patients aged 18 to 65 years with moderate to severe chronic low\u2010back pain and Modic type 1 changes were enrolled from five Norwegian public hospitals between January 2019 and October 2022. Participants were randomly assigned to four intravenous infusions of 5 mg\/kg infliximab or placebo. The primary outcome was difference in change in the Oswestry Disability Index (ODI) score from baseline to five months. Secondary outcomes included changes in low\u2010back pain intensity, disability, and health\u2010related quality of life. A linear mixed model was used for efficacy analyses.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 128 patients (mean age 43 years, 65.6% women) participated (64 in each group). All patients who received at least one dose of the allocated infusion were included in the primary analyses. The average ODI score (\u00b1SD) change was \u22127.0 (\u00b19.7) in the group who received infliximab and \u22126.4 (\u00b110.4) in the group who received placebo. The difference in the ODI score change between the two groups was 1.3 ODI points (95% confidence interval \u22122.1 to 4.6, <jats:italic>P<\/jats:italic> = 0.45). Analyses showed no effect of infliximab compared to placebo on secondary outcomes. Adverse event rates were similar between groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Infliximab did not demonstrate superiority over placebo in reducing pain\u2010related disability in patients with moderate to severe chronic low\u2010back pain with Modic type 1 changes at five months.<\/jats:p><jats:p><jats:boxed-text content-type=\"graphic\" position=\"anchor\"><jats:graphic xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" mimetype=\"image\/png\" position=\"anchor\" specific-use=\"enlarged-web-image\" xlink:href=\"graphic\/art43073-toc-0001-m.png\"><jats:alt-text>image<\/jats:alt-text><\/jats:graphic><\/jats:boxed-text><\/jats:p><\/jats:sec>","DOI":"10.1002\/art.43073","type":"journal-article","created":{"date-parts":[[2024,12,3]],"date-time":"2024-12-03T03:45:24Z","timestamp":1733197524000},"page":"615-623","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Efficacy of a Tumor Necrosis Factor Inhibitor in Chronic Low\u2010Back Pain With Modic Type 1 Changes: A Randomized Controlled Trial"],"prefix":"10.1002","volume":"77","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0470-7225","authenticated-orcid":false,"given":"Elisabeth","family":"Gjefsen","sequence":"first","affiliation":[{"name":"Oslo University Hospital and University of Oslo  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars C.","family":"Br\u00e5ten","sequence":"additional","affiliation":[{"name":"Oslo University Hospital  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erica","family":"Ponzi","sequence":"additional","affiliation":[{"name":"Oslo University Hospital  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magnhild H.","family":"Dagestad","sequence":"additional","affiliation":[{"name":"Haukeland University Hospital and University of Bergen  Bergen 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University of Science and Technology  Trondheim Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tonje W.","family":"Fl\u00f8renes","sequence":"additional","affiliation":[{"name":"Haukeland University Hospital and University of Bergen  Bergen Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nils","family":"Vetti","sequence":"additional","affiliation":[{"name":"Haukeland University Hospital and University of Bergen  Bergen Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars","family":"Gr\u00f8vle","sequence":"additional","affiliation":[{"name":"\u00d8stfold Hospital Trust  Gr\u00e5lum Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9821-8785","authenticated-orcid":false,"given":"Aksel T.","family":"Nilsen","sequence":"additional","affiliation":[{"name":"University Hospital of North Norway  Troms\u00f8 Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Astrid","family":"Lunestad","sequence":"additional","affiliation":[{"name":"Norwegian Association for Female Pelvic Joint Health, Gr\u00f8nland  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thor E.","family":"Holmgard","sequence":"additional","affiliation":[{"name":"Norwegian Back Pain Association  Drammen Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morten","family":"Valberg","sequence":"additional","affiliation":[{"name":"Oslo University Hospital and University of Oslo  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nils","family":"Bolstad","sequence":"additional","affiliation":[{"name":"Oslo University Hospital  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ansgar","family":"Espeland","sequence":"additional","affiliation":[{"name":"Haukeland University Hospital and University of Bergen  Bergen 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