{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T16:00:18Z","timestamp":1781712018943,"version":"3.54.5"},"reference-count":34,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2024,8,28]],"date-time":"2024-08-28T00:00:00Z","timestamp":1724803200000},"content-version":"unspecified","delay-in-days":27,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100011110","name":"UCB","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011110","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2024,7,29]]},"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>This post hoc analysis evaluated the relationship between objective measures of inflammation and clinical outcomes following 12 weeks of certolizumab pegol (CZP) treatment in patients with active axial spondyloarthritis (axSpA).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We report the proportion of patients achieving \u226550%\u2009and \u226575% improvements in clinical composite outcome measures of disease activity (Axial Spondyloarthritis Disease Activity Score [ASDAS], Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]) and objective measures of inflammation (C reactive protein [CRP], Ankylosing Spondylitis spine MRI score [ASspiMRI-a] Berlin score and Spondyloarthritis Research Consortium of Canada [SPARCC] MRI Sacroiliac Joints [SIJ] score) following 12 weeks of CZP treatment. Data from two independent readers over four MRI reading campaigns were pooled using a mixed model with repeated measures for each variable.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>136 patients (radiographic axSpA [r-axSpA]: 76; non-radiographic axSpA [nr-axSpA]: 60) were included. Following CZP treatment, CRP, ASspiMRI-a Berlin score and SPARCC SIJ score were reduced by \u226550% in most patients (CRP: 136\/136 [100.0%]; Berlin: 73\/136 [53.7%]; SPARCC SIJ: 71\/136 [52.2%]), and often by \u226575%. Less than half of patients with r-axSpA and nr-axSpA showed \u226550% reduction in clinical responses (BASDAI: 64\/136 [47.1%]; ASDAS: 66\/136 [48.5%]). These results were also observed at the individual patient level; \u226550% improvements in MRI\/CRP inflammatory measures did not translate into similar improvements in clinical responses for most patients.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>There is a potential disconnect between objective measures of inflammation and clinical outcome responses in patients with axSpA. The use of only clinical response measures as trial endpoints may underestimate anti-inflammatory treatment effects.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT01087762\">NCT01087762<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2024-004369","type":"journal-article","created":{"date-parts":[[2024,8,29]],"date-time":"2024-08-29T00:00:24Z","timestamp":1724889624000},"page":"e004369","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["Exploratory analysis of the potential disconnect between objective inflammatory response and clinical response following certolizumab pegol treatment in patients with active axial spondyloarthritis"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct01087762","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01087762","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01087762","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5445-548X","authenticated-orcid":false,"given":"Martin","family":"Rudwaleit","sequence":"first","affiliation":[{"name":"University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9683-3407","authenticated-orcid":false,"given":"Helena","family":"Marzo-Ortega","sequence":"additional","affiliation":[{"name":"Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK"},{"name":"NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4527-852X","authenticated-orcid":false,"given":"Victoria","family":"Navarro-Comp\u00e1n","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel","family":"Tham","sequence":"additional","affiliation":[{"name":"UCB Pharma, Slough, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Kumke","sequence":"additional","affiliation":[{"name":"UCB Pharma, Monheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars","family":"Bauer","sequence":"additional","affiliation":[{"name":"UCB Pharma, Monheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natasha","family":"de Peyrecave","sequence":"additional","affiliation":[{"name":"UCB Pharma, Brussels, 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