{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T18:27:00Z","timestamp":1781029620690,"version":"3.54.1"},"reference-count":33,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2021,2,10]],"date-time":"2021-02-10T00:00:00Z","timestamp":1612915200000},"content-version":"unspecified","delay-in-days":9,"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":[[2020,12,3]]},"published-print":{"date-parts":[[2021,2]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>Evaluation of the efficacy and safety of guselkumab, a human monoclonal antibody targeting the interleukin-23p19 subunit, in patients with psoriatic arthritis (PsA) through 1\u2009year.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Adults who met ClASsification criteria for Psoriatic ARthritis, with active disease (\u22653 swollen and \u22653 tender joints; C reactive protein \u22650.3\u2009mg\/dL) despite standard treatment (31% previously received \u22642 tumour necrosis factor inhibitors (TNFi)), were randomised (1:1:1) to guselkumab 100\u2009mg every 4 weeks (Q4W); guselkumab 100\u2009mg at Week0, Week4, then Q8W; or placebo with cross-over to guselkumab 100\u2009mg Q4W at Week24 (PBO\u2192Q4W) through Week48. Clinical efficacy through Week52 (employing non-responder imputation) and adverse events (AEs) through Week60 were evaluated.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Of 381 treated patients, 90% completed the study. Numerical increases in the proportions of patients achieving \u226520% improvement in ACR criteria (ACR20) were observed post-Week24, reaching 73% (94\/128) and 60% (76\/127) for Q4W-randomised and Q8W-randomised patients, respectively, by Week52. Proportions of patients achieving ACR50\/ACR70\/skin responses and minimal\/very low disease activity were maintained, as were improvements in physical function and health-related quality of life, through Week52 in guselkumab-randomised patients. Response to guselkumab was maintained in both TNFi-na\u00efve and TNFi-experienced patients. Serious AEs and serious infections occurred in similar proportions of guselkumab Q4W-randomised (3% and 0%) and Q8W-randomised (6% and 2%) patients through Week60, with no new safety concerns versus observations through Week24. No guselkumab-treated patient and two patients receiving placebo died; no study participant developed opportunistic infection or inflammatory bowel disease.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Guselkumab provided sustained improvement across multiple clinical manifestations of PsA, maintaining a favourable benefit-risk profile, through 1\u2009year regardless of prior TNFi exposure.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2020-001457","type":"journal-article","created":{"date-parts":[[2021,2,10]],"date-time":"2021-02-10T12:35:53Z","timestamp":1612960553000},"page":"e001457","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":67,"title":["Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-na\u00efve or TNF\u03b1 inhibitor-experienced"],"prefix":"10.1136","volume":"7","clinical-trial-number":[{"clinical-trial-number":"nct03162796","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2602-1219","authenticated-orcid":false,"given":"Christopher T","family":"Ritchlin","sequence":"first","affiliation":[{"name":"Rheumatology, University of Rochester Medical Center, Rochester, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4155-9105","authenticated-orcid":false,"given":"Philip S","family":"Helliwell","sequence":"additional","affiliation":[{"name":"Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, West Yorkshire, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wolf-Henning","family":"Boehncke","sequence":"additional","affiliation":[{"name":"Dermatology, University of Geneva Hospitals, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3143-1084","authenticated-orcid":false,"given":"Enrique R","family":"Soriano","sequence":"additional","affiliation":[{"name":"Rheumatology Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Federal District, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth C","family":"Hsia","sequence":"additional","affiliation":[{"name":"Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA"},{"name":"Rheumatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexa P","family":"Kollmeier","sequence":"additional","affiliation":[{"name":"Immunology, Janssen Research & Development LLC, San Diego, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7957-838X","authenticated-orcid":false,"given":"Soumya D","family":"Chakravarty","sequence":"additional","affiliation":[{"name":"Rheumatology, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA"},{"name":"Immunology Medical Affairs, Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federico","family":"Zazzetti","sequence":"additional","affiliation":[{"name":"Immunology Medical Affairs, Janssen Latin America LLC, Buenos Aires, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramanand A","family":"Subramanian","sequence":"additional","affiliation":[{"name":"Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xie L","family":"Xu","sequence":"additional","affiliation":[{"name":"Immunology, Janssen Research & Development LLC, San Diego, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qing C","family":"Zuraw","sequence":"additional","affiliation":[{"name":"Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shihong","family":"Sheng","sequence":"additional","affiliation":[{"name":"Biostatistics, Janssen Research & Development LLC, Spring House, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yusang","family":"Jiang","sequence":"additional","affiliation":[{"name":"Biostatistics, Cytel Inc on behalf of Janssen Research & Development LLC, Spring House, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prasheen","family":"Agarwal","sequence":"additional","affiliation":[{"name":"Biostatistics, Janssen Research & 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(guselkumab) injection, for subcutaneous use. Janssen Biotech, Inc., Horsham, PA. Available: http:\/\/www.janssenlabels.com\/package-insert\/product-monograph\/prescribing-information\/TREMFYA-pi.pdf [Accessed 29 Jul 2020]."},{"key":"2025090312570895000_7.1.e001457.14","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30265-8"},{"key":"2025090312570895000_7.1.e001457.15","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30263-4"},{"key":"2025090312570895000_7.1.e001457.16","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2011.10111704"},{"key":"2025090312570895000_7.1.e001457.17","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2008.102053"},{"key":"2025090312570895000_7.1.e001457.18","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.150826"},{"key":"2025090312570895000_7.1.e001457.19","doi-asserted-by":"crossref","unstructured":"McInnes IB , Rahman P , Gottlieb AB , et al . Efficacy and safety of guselkumab, an interleukin\u201023p19\u2010specific monoclonal antibody, through 1 year in biologic\u2010na\u00efve psoriatic arthritis patients. Arthritis Rheumatol 2020.doi:10.1002\/art.41553","DOI":"10.1002\/art.41553"},{"key":"2025090312570895000_7.1.e001457.20","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-016-0557-4"},{"key":"2025090312570895000_7.1.e001457.21","doi-asserted-by":"crossref","first-page":"106-","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":"2025090312570895000_7.1.e001457.22","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-208337"},{"key":"2025090312570895000_7.1.e001457.23","doi-asserted-by":"publisher","DOI":"10.1186\/ar2670"},{"key":"2025090312570895000_7.1.e001457.24","first-page":"S64","article-title":"Measures of psoriatic arthritis: Tender and Swollen Joint Assessment, Psoriasis Area and Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI), Modified Nail Psoriasis Severity Index (mNAPSI), Mander\/Newcastle Enthesitis Index (MEI), Leeds Enthesitis Index (LEI), Spondyloarthritis Research Consortium of Canada (SPARCC), Maastricht Ankylosing Spondylitis Enthesis Score (MASES), Leeds Dactylitis Index (LDI), Patient Global for Psoriatic Arthritis, Dermatology Life Quality Index (DLQI), Psoriatic Arthritis Quality of Life (PsAQOL), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Psoriatic Arthritis Response Criteria (PsARC), Psoriatic Arthritis Joint Activity Index (PsAJAI), Disease Activity in Psoriatic Arthritis (DAPSA), and Composite Psoriatic Disease Activity Index (CPDAI)","volume":"63 Suppl 11","author":"Mease","year":"2011","journal-title":"Arthritis Care Res"},{"key":"2025090312570895000_7.1.e001457.25","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2019.11.040"},{"key":"2025090312570895000_7.1.e001457.26","first-page":"1","article-title":"Continuous treatment with guselkumab maintains clinical responses through 4 years in patients with moderate-to-severe psoriasis: results from VOYAGE 1","author":"Griffiths","year":"2020","journal-title":"J Dermatolog Treat"},{"key":"2025090312570895000_7.1.e001457.27","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2016.11.042"},{"key":"2025090312570895000_7.1.e001457.28","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2016.11.041"},{"key":"2025090312570895000_7.1.e001457.29","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31773-8"},{"key":"2025090312570895000_7.1.e001457.30","doi-asserted-by":"publisher","DOI":"10.1080\/09546634.2019.1605133"},{"key":"2025090312570895000_7.1.e001457.31","first-page":"623","article-title":"Treatment patterns among patients with psoriatic arthritis treated with a biologic in the United States: descriptive analyses from an administrative claims database","volume":"24","author":"Walsh","year":"2018","journal-title":"J Manag Care Spec Pharm"},{"key":"2025090312570895000_7.1.e001457.32","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2020.1754186"},{"key":"2025090312570895000_7.1.e001457.33","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.15653"}],"container-title":["RMD Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/rmdopen-2020-001457","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,3]],"date-time":"2025-09-03T19:57:15Z","timestamp":1756929435000},"score":1,"resource":{"primary":{"URL":"https:\/\/rmdopen.bmj.com\/lookup\/doi\/10.1136\/rmdopen-2020-001457"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,2]]},"references-count":33,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2021,2,10]]},"published-print":{"date-parts":[[2021,2]]}},"alternative-id":["10.1136\/rmdopen-2020-001457"],"URL":"https:\/\/doi.org\/10.1136\/rmdopen-2020-001457","relation":{},"ISSN":["2056-5933"],"issn-type":[{"value":"2056-5933","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,2]]}}}