{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,11]],"date-time":"2025-09-11T17:26:53Z","timestamp":1757611613464,"version":"3.44.0"},"reference-count":25,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2022,3,16]],"date-time":"2022-03-16T00:00:00Z","timestamp":1647388800000},"content-version":"unspecified","delay-in-days":15,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"UCB Pharma"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2022,2,21]]},"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>52-week results from C-axSpAnd demonstrated the safety and efficacy of certolizumab pegol (CZP) in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation (sacroiliitis on MRI and\/or elevated C-reactive protein levels). Long-term safety and clinical outcomes, including MRI assessments, are evaluated up to 3 years for CZP-treated patients with nr-axSpA.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>C-axSpAnd was a phase 3 study comprising a 1-year double-blind, placebo-controlled period and 2-year open-label safety follow-up extension (SFE). At baseline, 317 patients were randomised 1:1 to placebo or CZP 200 mg every 2 weeks. Patients completing the double-blind phase who enrolled into the SFE received open-label CZP for an additional 104 weeks. Long-term safety and clinical outcomes are reported to Week 156. Continuous outcomes are presented as observed case (OC) and dichotomous outcomes as OC and with non-responder imputation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>243\/317 (76.7%) patients entered the SFE, during which 149 (61.3%) experienced \u22651 treatment-emergent adverse event (TEAE); 15 (3.3\/100 patient-years) experienced serious TEAEs. Continuous outcome scores (including Ankylosing Spondylitis Disease Activity Score [ASDAS]: 1.8; Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]: 2.7) at Week 52 were maintained at Week 156 (ASDAS: 1.8; BASDAI: 2.6) for the initial CZP-randomised group. Mean SPARCC MRI sacroiliac joint inflammation scores for these patients decreased at Week 52 (baseline: 7.6; Week 52: 1.7), remaining low at Week 156 (2.4).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>CZP treatment was well tolerated up to 3 years, with no new safety signals versus previous reports. Clinical outcomes achieved after 1 year were sustained to 3 years.<\/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=\"NCT02552212\">NCT02552212<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2021-002138","type":"journal-article","created":{"date-parts":[[2022,3,16]],"date-time":"2022-03-16T12:12:06Z","timestamp":1647432726000},"page":"e002138","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":8,"title":["Long-term safety and clinical outcomes of certolizumab pegol treatment in patients with active non-radiographic axial spondyloarthritis: 3-year results from the phase 3 C-axSpAnd study"],"prefix":"10.1136","volume":"8","clinical-trial-number":[{"clinical-trial-number":"nct02552212","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02552212","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02552212","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5781-158X","authenticated-orcid":false,"given":"D\u00e9sir\u00e9e","family":"van der Heijde","sequence":"first","affiliation":[{"name":"Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6314-5336","authenticated-orcid":false,"given":"Lianne S","family":"Gensler","sequence":"additional","affiliation":[{"name":"Department of Medicine\/Rheumatology, University of California San Francisco, San Francisco, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1291-1755","authenticated-orcid":false,"given":"Walter P","family":"Maksymowych","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Alberta, Edmonton, Alberta, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0577-6620","authenticated-orcid":false,"given":"Robert","family":"Landew\u00e9","sequence":"additional","affiliation":[{"name":"Rheumatology Department, Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam, The Netherlands"},{"name":"Rheumatology, Zuyderland Medical Centre, Heerlen, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5445-548X","authenticated-orcid":false,"given":"Martin","family":"Rudwaleit","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Rheumatology, University of Bielefeld, Bielefeld, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lars","family":"Bauer","sequence":"additional","affiliation":[{"name":"UCB Pharma, Monheim am Rhein, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Kumke","sequence":"additional","affiliation":[{"name":"UCB Pharma, Monheim am Rhein, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mindy","family":"Kim","sequence":"additional","affiliation":[{"name":"UCB Pharma, Smyrna, Georgia, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2018-7998","authenticated-orcid":false,"given":"Simone Emanuele","family":"Auteri","sequence":"additional","affiliation":[{"name":"UCB Pharma, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bengt","family":"Hoepken","sequence":"additional","affiliation":[{"name":"UCB Pharma, Monheim am Rhein, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2130-1246","authenticated-orcid":false,"given":"Atul","family":"Deodhar","sequence":"additional","affiliation":[{"name":"Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2022,3,16]]},"reference":[{"key":"2025090313403867000_8.1.e002138.1","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2015-000053"},{"key":"2025090313403867000_8.1.e002138.2","doi-asserted-by":"publisher","DOI":"10.1002\/art.24483"},{"key":"2025090313403867000_8.1.e002138.3","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210770"},{"key":"2025090313403867000_8.1.e002138.4","doi-asserted-by":"crossref","first-page":"1599","DOI":"10.1002\/art.41042","article-title":"2019 update of the American College of Rheumatology\/Spondylitis Association of America\/Spondyloarthritis Research and Treatment Network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis","volume":"71","author":"Ward","year":"2019","journal-title":"Arthritis Rheumatol"},{"key":"2025090313403867000_8.1.e002138.5","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204231"},{"key":"2025090313403867000_8.1.e002138.6","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2020-eular.4182"},{"key":"2025090313403867000_8.1.e002138.7","doi-asserted-by":"crossref","first-page":"668","DOI":"10.1002\/art.38973","article-title":"Effect of certolizumab pegol over ninety-six weeks in patients with axial spondyloarthritis: results from a phase III randomized trial","volume":"67","author":"Sieper","year":"2015","journal-title":"Arthritis Rheumatol"},{"key":"2025090313403867000_8.1.e002138.8","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2017-212377"},{"key":"2025090313403867000_8.1.e002138.9","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2019-001161"},{"key":"2025090313403867000_8.1.e002138.10","unstructured":"European Medicines Agency (EMA) . CIMZIA (Certolizumab pegol) summary of product characteristics, 2021. Available: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/cimzia-epar-product-information_en.pdf [Accessed Nov 2021]."},{"key":"2025090313403867000_8.1.e002138.11","doi-asserted-by":"crossref","first-page":"1101","DOI":"10.1002\/art.40866","article-title":"A fifty-two-week, randomized, placebo-controlled trial of certolizumab pegol in nonradiographic axial spondyloarthritis","volume":"71","author":"Deodhar","year":"2019","journal-title":"Arthritis Rheumatol"},{"key":"2025090313403867000_8.1.e002138.12","unstructured":"U.S. Food and Drug Administration . CIMZIA (certolizumab pegol) highlights of prescribing information. Available: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/125160s293lbl.pdf [Accessed Nov 2021]."},{"key":"2025090313403867000_8.1.e002138.13","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)31362-X"},{"key":"2025090313403867000_8.1.e002138.14","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2021-eular.3824"},{"key":"2025090313403867000_8.1.e002138.15","doi-asserted-by":"crossref","first-page":"70.1","DOI":"10.1136\/annrheumdis-2020-eular.1322","article-title":"OP0107 Etanercept withdrawal and re-treatment in patients with inactive non-radiographic axial spondyloarthritis at 24 weeks: results of re-embark, an open-label, phase IV trial","volume":"79","author":"Van den Bosch","year":"2020","journal-title":"Ann Rheum Dis"},{"key":"2025090313403867000_8.1.e002138.16","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2010.133645"},{"key":"2025090313403867000_8.1.e002138.17","doi-asserted-by":"publisher","DOI":"10.1002\/art.21445"},{"key":"2025090313403867000_8.1.e002138.18","unstructured":"World Health Organization . Global tuberculosis report, 2020. Available: https:\/\/www.who.int\/teams\/global-tuberculosis-programme\/tb-reports [Accessed Nov 2021]."},{"key":"2025090313403867000_8.1.e002138.19","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2019-000942"},{"key":"2025090313403867000_8.1.e002138.20","doi-asserted-by":"crossref","first-page":"1498","DOI":"10.1093\/rheumatology\/kex174","article-title":"Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA","volume":"56","author":"van der Heijde","year":"2017","journal-title":"Rheumatology"},{"key":"2025090313403867000_8.1.e002138.21","doi-asserted-by":"crossref","first-page":"110","DOI":"10.1002\/art.41477","article-title":"Improvement of signs and symptoms of nonradiographic axial spondyloarthritis in patients treated with secukinumab: primary results of a randomized, placebo-controlled phase III study","volume":"73","author":"Deodhar","year":"2021","journal-title":"Arthritis Rheumatol"},{"key":"2025090313403867000_8.1.e002138.22","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-207596"},{"key":"2025090313403867000_8.1.e002138.23","doi-asserted-by":"crossref","DOI":"10.1186\/s13075-018-1556-5","article-title":"Clinical and MRI remission in patients with nonradiographic axial spondyloarthritis who received long-term open-label adalimumab treatment: 3-year results of the ABILITY-1 trial","volume":"20","author":"van der Heijde","year":"2018","journal-title":"Arthritis Res Ther"},{"key":"2025090313403867000_8.1.e002138.24","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204948"},{"key":"2025090313403867000_8.1.e002138.25","doi-asserted-by":"crossref","first-page":"iv79","DOI":"10.1093\/rheumatology\/keaa435","article-title":"Treatment strategies in axial spondyloarthritis: what, when and how?","volume":"59","author":"Fragoulis","year":"2020","journal-title":"Rheumatology"}],"container-title":["RMD Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/rmdopen-2021-002138","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,3]],"date-time":"2025-09-03T20:40:47Z","timestamp":1756932047000},"score":1,"resource":{"primary":{"URL":"https:\/\/rmdopen.bmj.com\/lookup\/doi\/10.1136\/rmdopen-2021-002138"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3]]},"references-count":25,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2022,3,16]]},"published-print":{"date-parts":[[2022,3]]}},"alternative-id":["10.1136\/rmdopen-2021-002138"],"URL":"https:\/\/doi.org\/10.1136\/rmdopen-2021-002138","relation":{},"ISSN":["2056-5933"],"issn-type":[{"type":"electronic","value":"2056-5933"}],"subject":[],"published":{"date-parts":[[2022,3]]}}}