{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T16:57:09Z","timestamp":1788195429920,"version":"build-2803163510"},"reference-count":33,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2020,2,7]],"date-time":"2020-02-07T00:00:00Z","timestamp":1581033600000},"content-version":"unspecified","delay-in-days":6,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research and Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2020,1,10]]},"published-print":{"date-parts":[[2020,2]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The interleukin-12\/23p40-subunit-inhibitor ustekinumab significantly improved spondylitis-related symptoms through Week 24 in psoriatic arthritis (PsA) patients with peripheral arthritis and physician-reported spondylitis (PA-PRS) in PSUMMIT-1&amp;2. We further evaluated ustekinumab\u2019s effect on spondylitis-related endpoints in PSUMMIT-1&amp;2 tumour necrosis factor-inhibitor (TNFi)-na\u00efve patients with PA-PRS.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Patients with active PsA (\u22655 swollen and \u22655 tender joints, C-reactive-protein \u2265 3.0\u2009mg\/L) despite conventional (PSUMMIT-1&amp;2) and\/or prior TNFi (PSUMMIT-2) therapy received subcutaneous ustekinumab 45\u2009mg, 90\u2009mg or placebo (Week 0, Week 4, Week 16). Changes in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) neck\/back\/hip pain question (#2) and modified BASDAI (mBASDAI, excluding PA) scores and Ankylosing Spondylitis Disease Activity Score (ASDAS) responses were assessed at Weeks 12 and 24.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The pooled PSUMMIT-1&amp;2, TNFi-na\u00efve (n=747), PA-PRS (n=223) subset (158 with human-leucocyte-antigen (<jats:italic>HLA)-B27<\/jats:italic> results) presented with moderate-to-severe spondylitis-related symptoms (mean BASDAI-neck\/back\/hip pain-6.51, mBASDAI-6.54, BASDAI-6.51, ASDAS-3.81). Mean Week 24 changes were larger among ustekinumab than placebo-treated patients for both neck\/back\/hip pain (\u22121.99 vs \u22120.18) and mBASDAI (\u22122.09 vs \u22120.59). Improvements in neck\/back\/hip pain and fatigue appeared numerically greater in <jats:italic>HLA-B27<jats:sup>+<\/jats:sup>\n                     <\/jats:italic> than <jats:italic>HLA-B27<jats:bold>\n                           <jats:sup>\u2013<\/jats:sup>\n                        <\/jats:bold>\n                     <\/jats:italic> patients; those for other domains were generally consistent. Greater proportions of ustekinumab versus placebo-treated patients achieved ASDAS clinically important improvement at Week 24 (decrease \u2265 1.1; 49.6% vs 12.7%; nominal p&lt;0.05).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Improvements in BASDAI neck\/back\/hip pain and mBASDAI among ustekinumab-treated, TNFi-na\u00efve, PsA patients with PA-PRS were clinically meaningful and consistent across assessment tools. Numerically greater improvements in neck\/back\/hip pain in <jats:italic>HLA-B27<jats:sup>+<\/jats:sup>\n                     <\/jats:italic> than <jats:italic>HLA-B27<jats:bold>\n                           <jats:sup>\u2013<\/jats:sup>\n                        <\/jats:bold>\n                     <\/jats:italic> patients, noted in the context of similar overall mBASDAI improvements between the subgroups, suggest ustekinumab may improve disease activity in TNFi-na\u00efve PsA patients likely to exhibit axial disease.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical trial registration numbers<\/jats:title>\n                  <jats:p>PSUMMIT 1, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT01009086\">NCT01009086<\/jats:ext-link>; PSUMMIT 2, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT01077362\">NCT01077362<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2019-001149","type":"journal-article","created":{"date-parts":[[2020,2,10]],"date-time":"2020-02-10T13:55:10Z","timestamp":1581342910000},"page":"e001149","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":61,"title":["Effects of ustekinumab on spondylitis-associated endpoints in TNFi-na\u00efve active psoriatic arthritis patients with physician-reported spondylitis: pooled results from two phase 3, randomised, controlled trials"],"prefix":"10.1136","volume":"6","clinical-trial-number":[{"clinical-trial-number":"nct01009086","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01077362","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01009086","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01077362","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4155-9105","authenticated-orcid":false,"given":"Philip S","family":"Helliwell","sequence":"first","affiliation":[{"name":"Section of Musculoskeletal Disease, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9074-0592","authenticated-orcid":false,"given":"Dafna D","family":"Gladman","sequence":"additional","affiliation":[{"name":"Krembil Institute, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Soumya D","family":"Chakravarty","sequence":"additional","affiliation":[{"name":"Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA"},{"name":"Drexel University College of Medicine, Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shelly","family":"Kafka","sequence":"additional","affiliation":[{"name":"Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chetan S","family":"Karyekar","sequence":"additional","affiliation":[{"name":"Janssen Global Services LLC, Horsham, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yin","family":"You","sequence":"additional","affiliation":[{"name":"Janssen Research & Development LLC, Spring House, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim","family":"Campbell","sequence":"additional","affiliation":[{"name":"Janssen Research & Development LLC, Spring House, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristen","family":"Sweet","sequence":"additional","affiliation":[{"name":"Janssen Research & Development LLC, Spring House, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arthur","family":"Kavanaugh","sequence":"additional","affiliation":[{"name":"University of California San Diego, La Jolla, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lianne S","family":"Gensler","sequence":"additional","affiliation":[{"name":"University of California San Francisco School of Medicine, San Francisco, California, 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Efficacy and safety of risankizumab, a selective IL-23p19 inhibitor, in patients with active psoriatic arthritis over 24 weeks: results from a phase 2 trial. Ann Rheum Dis 2018;77. Oral presentation 0307.","DOI":"10.1136\/annrheumdis-2018-eular.2140"},{"key":"2025090312412718000_6.1.e001149.24","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2018-213328"},{"key":"2025090312412718000_6.1.e001149.25","doi-asserted-by":"crossref","first-page":"1587","DOI":"10.2147\/TCRM.S100091","article-title":"Secukinumab for ankylosing spondylitis and psoriatic arthritis","volume":"12","author":"Lubrano","year":"2016","journal-title":"Ther Clin Risk Manag"},{"key":"2025090312412718000_6.1.e001149.26","doi-asserted-by":"crossref","unstructured":"Baraliakos X , Coates LC , Gossec L , et al . Secukinumab improves axial manifestations in patients with psoriatic arthritis and inadequate response to NSAIDs: primary analysis of the MAXIMISE trial. Ann Rheum Dis 2019;78. 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