{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T21:21:18Z","timestamp":1791062478613,"version":"4.1.0"},"reference-count":37,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2019,5,28]],"date-time":"2019-05-28T00:00:00Z","timestamp":1559001600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015661","name":"UCB Pharma","doi-asserted-by":"crossref","award":["N\/a"],"award-info":[{"award-number":["N\/a"]}],"id":[{"id":"10.13039\/100015661","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2019,7]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>\n                      The natural history of nonradiographic axial spondyloarthritis (SpA) is incompletely characterized, and there are concerns that nonsteroidal antiinflammatory drugs provide inadequate disease control in patients with active disease. This study was undertaken to investigate the effects of certolizumab pegol (\n                      <jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>\n                      ), an anti\u2013tumor necrosis factor treatment, in patients with nonradiographic axial SpA with objective signs of inflammation.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In this ongoing parallel\u2010group double\u2010blind study, adults with active disease were recruited from 80 centers in Australia, Europe, North America, and Taiwan, and were randomized 1:1 to receive placebo or\n                      <jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>\n                      (400 mg at weeks 0, 2, and 4, followed by 200 mg every 2 weeks) in addition to nonbiologic background medication (\n                      <jats:styled-content style=\"fixed-case\">NBBM<\/jats:styled-content>\n                      ). Switching to open\u2010label\n                      <jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>\n                      (or other biologic) or making background medication changes was permitted at any point during the trial, although changes before week 12 were discouraged. The primary end point was the proportion of patients achieving major improvement (\n                      <jats:styled-content style=\"fixed-case\">MI<\/jats:styled-content>\n                      ) (i.e., a \u22652.0\u2010point decrease in the score from baseline or achievement of the lowest possible score [0.6]) in the Ankylosing Spondylitis Disease Activity Score (\n                      <jats:styled-content style=\"fixed-case\">ASDAS<\/jats:styled-content>\n                      ) at week 52.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 317 patients were randomized to receive placebo plus\n                      <jats:styled-content style=\"fixed-case\">NBBM<\/jats:styled-content>\n                      (n = 158) or\n                      <jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>\n                      plus\n                      <jats:styled-content style=\"fixed-case\">NBBM<\/jats:styled-content>\n                      (n = 159).\n                      <jats:styled-content style=\"fixed-case\">ASDAS<\/jats:styled-content>\n                      \u2010\n                      <jats:styled-content style=\"fixed-case\">MI<\/jats:styled-content>\n                      at week 52 was achieved in 47.2% (75 of 159) of\n                      <jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>\n                      plus\n                      <jats:styled-content style=\"fixed-case\">NBBM<\/jats:styled-content>\n                      patients, which was significantly greater (\n                      <jats:italic>P<\/jats:italic>\n                      &lt; 0.0001) than the 7.0% (11 of 158) of placebo plus\n                      <jats:styled-content style=\"fixed-case\">NBBM<\/jats:styled-content>\n                      patients in whom ASDAS\u2010MI was achieved. Of the placebo plus\n                      <jats:styled-content style=\"fixed-case\">NBBM<\/jats:styled-content>\n                      patients, 60.8% (96 of 158) switched to open\u2010label treatment before week 52 compared to 12.6% (20 of 159) of the\n                      <jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>\n                      plus\n                      <jats:styled-content style=\"fixed-case\">NBBM<\/jats:styled-content>\n                      patients.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      Adding\n                      <jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>\n                      to background medication is superior to adding placebo in patients with active nonradiographic axial SpA. These results indicate that remission in nonradiographic axial SpA treated without biologics occurs infrequently, demonstrating the need for treatment beyond nonbiologic therapy.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/art.40866","type":"journal-article","created":{"date-parts":[[2019,3,8]],"date-time":"2019-03-08T06:09:35Z","timestamp":1552025375000},"page":"1101-1111","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":90,"title":["A Fifty\u2010Two\u2013Week, Randomized, Placebo\u2010Controlled Trial of Certolizumab Pegol in Nonradiographic Axial Spondyloarthritis"],"prefix":"10.1002","volume":"71","author":[{"given":"Atul","family":"Deodhar","sequence":"first","affiliation":[{"name":"Oregon Health &amp; Science University  Portland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lianne S.","family":"Gensler","sequence":"additional","affiliation":[{"name":"University of 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