{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T02:17:16Z","timestamp":1785377836719,"version":"3.55.0"},"reference-count":19,"publisher":"BMJ","issue":"2","funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research & Development, LLC","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2019,7,22]]},"published-print":{"date-parts":[[2019,8]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To evaluate the efficacy of ustekinumab by prior treatment exposure and disease duration in tumour necrosis factor inhibitor (TNF)-na\u00efve patients with psoriatic arthritis (PsA) in the PSUMMIT 1 and PSUMMIT 2 studies.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In the phase 3, randomised, placebo-controlled PSUMMIT 1 and PSUMMIT 2 studies, adults with active PsA for \u22656 months despite conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and\/or non-steroidal anti-inflammatory drugs (NSAIDs) (PSUMMIT 1) or csDMARDs, NSAIDs and\/or anti-TNF agents (PSUMMIT 2) were enrolled. Patients were randomised to subcutaneous injections of placebo, ustekinumab 45\u2009mg or ustekinumab 90\u2009mg at weeks 0 and 4 and every 12 weeks. Efficacy was assessed at week 24 using the American College of Rheumatology criteria and 28-joint count disease activity score using C reactive protein (DAS28-CRP); radiographical progression, enthesitis, and dactylitis were also assessed in this post hoc analysis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 747 patients were included; all 747 were TNF-na\u00efve, of which, 179 were methotrexate-na\u00efve and TNF-na\u00efve, and 146 were all csDMARD-na\u00efve and TNF-na\u00efve. At week 24, greater proportions of ustekinumab-treated patients had \u226520%\/50%\/70% improvement in American College of Rheumatology criteria (ACR20\/ACR50\/ACR70) responses, DAS28-CRP response and DAS28-CRP remission versus placebo in all three prior-treatment populations, with similar differences between treatment groups. Greater proportions of ustekinumab-treated patients also had complete resolution of enthesitis and dactylitis at week 24 across the three prior-treatment populations. Mean changes from baseline in total van der Heijde-Sharp Score at week 24 were generally smaller for ustekinumab-treated patients versus placebo but were statistically significant only in the full TNF-na\u00efve population. Response rates for ACR20\/ACR50\/ACR70 were similar for TNF-na\u00efve patients with PsA durations of &lt;1\u2009year, \u22651\u2009to &lt;3 years, and \u22653 years.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Ustekinumab-treated patients demonstrated greater clinical response at week 24 compared with placebo regardless of prior treatment exposure and PsA disease duration.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2019-000990","type":"journal-article","created":{"date-parts":[[2019,8,19]],"date-time":"2019-08-19T06:14:15Z","timestamp":1566195255000},"page":"e000990","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":25,"title":["Efficacy of ustekinumab in biologic-na\u00efve patients with psoriatic arthritis by prior treatment exposure and disease duration: data from PSUMMIT 1 and PSUMMIT 2"],"prefix":"10.1136","volume":"5","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4449-8501","authenticated-orcid":false,"given":"Iain B","family":"McInnes","sequence":"first","affiliation":[{"name":"Institute of Infection, Immunity & Inflammation, University of Glasgow, Glasgow, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Soumya D","family":"Chakravarty","sequence":"additional","affiliation":[{"name":"Immunology Medical Affairs, Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, USA"},{"name":"Drexel University, College of Medicine, Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabel","family":"Apaolaza","sequence":"additional","affiliation":[{"name":"Medical Affairs, Janssen Biologics BV, Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shelly","family":"Kafka","sequence":"additional","affiliation":[{"name":"Immunology Medical Affairs, Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth C","family":"Hsia","sequence":"additional","affiliation":[{"name":"Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA"},{"name":"Division of Rheumatology, University of Pennslyvania, Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yin","family":"You","sequence":"additional","affiliation":[{"name":"Biostatistics, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arthur","family":"Kavanaugh","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of California, San Diego, School of Medicine, La Jolla, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2019,8,18]]},"reference":[{"key":"2025090312062041000_5.2.e000990.1","doi-asserted-by":"crossref","first-page":"1060","DOI":"10.1002\/art.39573","article-title":"Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2015 treatment recommendations for psoriatic arthritis","volume":"68","author":"Coates","year":"2016","journal-title":"Arthritis Rheumatol"},{"key":"2025090312062041000_5.2.e000990.2","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1002\/art.40726","article-title":"Special article: 2018 American College of Rheumatology\/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis","volume":"71","author":"Singh","year":"2019","journal-title":"Arthritis Rheumatol"},{"key":"2025090312062041000_5.2.e000990.3","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-203419"},{"key":"2025090312062041000_5.2.e000990.4","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)60594-2"},{"key":"2025090312062041000_5.2.e000990.5","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204655"},{"key":"2025090312062041000_5.2.e000990.6","doi-asserted-by":"crossref","first-page":"1739","DOI":"10.1002\/acr.22645","article-title":"Maintenance of clinical efficacy and radiographic benefit through two years of ustekinumab therapy in patients with active psoriatic arthritis: results from a randomized, placebo-controlled phase III trial","volume":"67","author":"Kavanaugh","year":"2015","journal-title":"Arthritis Care Res (Hoboken)"},{"key":"2025090312062041000_5.2.e000990.7","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780380602"},{"key":"2025090312062041000_5.2.e000990.8","doi-asserted-by":"crossref","unstructured":"van Riel P , van Gestel AM , Scott DL . EULAR Handbook of clinical assessments in rheumatoid arthritis. Alphen Aan Den Rijn, The Netherlands: Van Zuiden Communications, BV, 2000.","DOI":"10.1136\/ard.59.suppl_1.i28"},{"key":"2025090312062041000_5.2.e000990.9","doi-asserted-by":"publisher","DOI":"10.1136\/ard.62.2.127"},{"key":"2025090312062041000_5.2.e000990.10","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2004.030809"},{"key":"2025090312062041000_5.2.e000990.11","doi-asserted-by":"crossref","first-page":"667","DOI":"10.1007\/s10067-018-3989-2","article-title":"Drug survival and effectiveness of ustekinumab in patients with psoriatic arthritis. real-life data from the biologic Apulian registry (BIOPURE)","volume":"37","author":"Iannone","year":"2018","journal-title":"Clin Rheumatol"},{"key":"2025090312062041000_5.2.e000990.12","doi-asserted-by":"publisher","DOI":"10.1002\/art.21177"},{"key":"2025090312062041000_5.2.e000990.13","doi-asserted-by":"publisher","DOI":"10.1002\/art.22443"},{"key":"2025090312062041000_5.2.e000990.14","doi-asserted-by":"crossref","unstructured":"McInnes IB , Puig L , Gottlieb AB , et al . Association between enthesitis and health-related quality of life in psoriatic arthritis in biologic-naive patients from 2 phase III ustekinumab trials. J Rheumatol 2019:jrheum.180792.doi:10.3899\/jrheum.180792","DOI":"10.3899\/jrheum.180792"},{"key":"2025090312062041000_5.2.e000990.15","doi-asserted-by":"crossref","first-page":"1692","DOI":"10.1002\/acr.23249","article-title":"Clinical characteristics, disease activity, and patient-reported outcomes in psoriatic arthritis patients with dactylitis or enthesitis: results from the Corrona psoriatic arthritis\/spondyloarthritis registry","volume":"69","author":"Mease","year":"2017","journal-title":"Arthritis Care Res (Hoboken)"},{"key":"2025090312062041000_5.2.e000990.16","doi-asserted-by":"publisher","DOI":"10.1038\/nm.2817"},{"key":"2025090312062041000_5.2.e000990.17","doi-asserted-by":"crossref","first-page":"1816","DOI":"10.1002\/art.40150","article-title":"Brief report: group 3 innate lymphoid cells in human enthesis","volume":"69","author":"Cuthbert","year":"2017","journal-title":"Arthritis Rheumatol"},{"key":"2025090312062041000_5.2.e000990.18","doi-asserted-by":"publisher","DOI":"10.1046\/j.1523-1747.1998.00446.x"},{"key":"2025090312062041000_5.2.e000990.19","doi-asserted-by":"publisher","DOI":"10.1084\/jem.20030451"}],"container-title":["RMD Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/rmdopen-2019-000990","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,3]],"date-time":"2025-09-03T19:06:28Z","timestamp":1756926388000},"score":1,"resource":{"primary":{"URL":"https:\/\/rmdopen.bmj.com\/lookup\/doi\/10.1136\/rmdopen-2019-000990"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,8]]},"references-count":19,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2019,8,18]]},"published-print":{"date-parts":[[2019,8]]}},"alternative-id":["10.1136\/rmdopen-2019-000990"],"URL":"https:\/\/doi.org\/10.1136\/rmdopen-2019-000990","relation":{},"ISSN":["2056-5933"],"issn-type":[{"value":"2056-5933","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,8]]}}}