{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T07:09:58Z","timestamp":1785481798505,"version":"3.56.0"},"reference-count":32,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2024,12,12]],"date-time":"2024-12-12T00:00:00Z","timestamp":1733961600000},"content-version":"unspecified","delay-in-days":11,"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":[[2024,8,13]]},"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To prospectively evaluate the effect of guselkumab through 48 weeks across various clinical outcomes in subgroups of patients with psoriatic arthritis (PsA) and inadequate response to tumour necrosis factor inhibitors (TNFi-IR) from the phase 3b COSMOS trial. Subgroups were defined by baseline demographics, disease characteristics and prior\/ongoing therapies.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Patients with active PsA (tender joint count (TJC) and swollen joint count (SJC) both \u22653) and TNFi-IR were randomised 2:1 to receive guselkumab 100 mg at week 0, week 4, then every 8 weeks through week 44 or to placebo with cross-over to guselkumab 100 mg at week 16 (early escape) or week 24 (planned). Guselkumab effect on joints (American College of Rheumatology (ACR) 20\/50\/70, enthesitis, dactylitis), skin (Psoriasis Area and Severity Index 90\/100, Investigator\u2019s Global Assessment 0\/1), patient-reported outcomes (PROs) (Functional Assessment of Chronic Illness Therapy\u2013Fatigue, Health Assessment Questionnaire\u2013Disability Index) and composite outcome measures (PsA Disease Activity Score low disease activity, minimal disease activity) were evaluated by baseline patient age, sex, body mass index, SJC, TJC, PsA duration, %body surface area, C reactive protein, pain Visual Analogue Scale, number of prior TNFi and discontinuation reason, and conventional synthetic disease-modifying antirheumatic drug status. Results are descriptive only.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Baseline characteristics were similar between guselkumab (n=189) and placebo (n=96) groups. The benefit of guselkumab over placebo in achieving ACR 20 (primary endpoint; 50% vs 28%) and ACR 50 (23% vs 8%) response at week 24 was observed within all subgroups. Furthermore, response rates in the guselkumab group increased between week 24 and week 48 within almost all subgroups. Similar response patterns at week 24 and through week 48 were observed across various clinical outcomes.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Guselkumab every 8 weeks led to consistent improvements through week 24 in joint, skin, PRO and composite outcomes versus placebo across diverse baseline-defined subgroups of TNFi-IR patients with PsA. Response rates increased or were durable through week 48 within most subgroups.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2024-004494","type":"journal-article","created":{"date-parts":[[2024,12,12]],"date-time":"2024-12-12T23:35:36Z","timestamp":1734046536000},"page":"e004494","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Sustained response to guselkumab regardless of baseline characteristics in patients with active psoriatic arthritis and inadequate response to TNF inhibitors: results from the phase 3b COSMOS clinical trial"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct03796858","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6462-4280","authenticated-orcid":false,"given":"Iain B","family":"McInnes","sequence":"first","affiliation":[{"name":"College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8465-6207","authenticated-orcid":false,"given":"Philipp","family":"Sewerin","sequence":"additional","affiliation":[{"name":"Rheumazentrum Ruhrgebiet, Ruhr-Universit\u00e4t Bochum, Herne, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-9847-2996","authenticated-orcid":false,"given":"Mohamed","family":"Sharaf","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Middle East FZ LLC, Dubai, UAE"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michela","family":"Efficace","sequence":"additional","affiliation":[{"name":"Janssen-Cilag SpA, Imperia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5213-257X","authenticated-orcid":false,"given":"Fr\u00e9d\u00e9ric","family":"Lavie","sequence":"additional","affiliation":[{"name":"The Janssen Pharmaceutical Companies of Johnson & Johnson, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6063-3000","authenticated-orcid":false,"given":"Miriam","family":"Zimmermann","sequence":"additional","affiliation":[{"name":"Janssen EMEA Medical Affairs, LLC, Zug, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4756-663X","authenticated-orcid":false,"given":"Laura C","family":"Coates","sequence":"additional","affiliation":[{"name":"Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,12,12]]},"reference":[{"key":"2025090313255060000_10.4.e004494.1","doi-asserted-by":"crossref","DOI":"10.1186\/s13075-017-1265-5","article-title":"Mitigation of disease- and treatment-related risks in patients with psoriatic arthritis","volume":"19","author":"Bergman","year":"2017","journal-title":"Arthritis Res Ther"},{"key":"2025090313255060000_10.4.e004494.2","doi-asserted-by":"crossref","DOI":"10.1136\/rmdopen-2021-002074","article-title":"Targeted systemic therapies for psoriatic arthritis: a systematic review and comparative synthesis of short-term articular, dermatological, enthesitis and dactylitis outcomes","volume":"8","author":"McInnes","year":"2022","journal-title":"RMD Open"},{"key":"2025090313255060000_10.4.e004494.3","doi-asserted-by":"publisher","DOI":"10.1002\/art.21972"},{"key":"2025090313255060000_10.4.e004494.4","doi-asserted-by":"crossref","DOI":"10.1136\/rmdopen-2022-002195","article-title":"Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: pooled results through week 52 of two phase III, randomised, placebo-controlled studies","volume":"8","author":"Ritchlin","year":"2022","journal-title":"RMD Open"},{"key":"2025090313255060000_10.4.e004494.5","first-page":"S104","article-title":"A short history of biological therapy for psoriatic arthritis","volume":"33","author":"Mease","year":"2015","journal-title":"Clin Exp Rheumatol"},{"key":"2025090313255060000_10.4.e004494.6","doi-asserted-by":"crossref","first-page":"4569","DOI":"10.1007\/s10067-021-05799-0","article-title":"Predictive factors for switching in patients with psoriatic arthritis undergoing anti-TNF\u03b1, anti-IL12\/23, or anti-IL17 drugs: a 15-year monocentric real-life study","volume":"40","author":"Lorenzin","year":"2021","journal-title":"Clin Rheumatol"},{"key":"2025090313255060000_10.4.e004494.7","doi-asserted-by":"crossref","DOI":"10.1186\/s13075-021-02680-y","article-title":"Sex-specific differences and how to handle them in early psoriatic arthritis","volume":"24","author":"Passia","year":"2022","journal-title":"Arthritis Res Ther"},{"key":"2025090313255060000_10.4.e004494.8","doi-asserted-by":"crossref","first-page":"447","DOI":"10.1007\/s40744-020-00215-6","article-title":"Obesity and psoriatic arthritis: a narrative review","volume":"7","author":"Kumthekar","year":"2020","journal-title":"Rheumatol Ther"},{"key":"2025090313255060000_10.4.e004494.9","doi-asserted-by":"crossref","first-page":"2663","DOI":"10.1007\/s10067-020-05027-1","article-title":"Retention rates and identification of factors associated with anti-TNF\u03b1, anti-IL17, and anti-IL12\/23R agents discontinuation in psoriatic arthritis patients: results from a real-world clinical setting","volume":"39","author":"Navarini","year":"2020","journal-title":"Clin Rheumatol"},{"key":"2025090313255060000_10.4.e004494.10","doi-asserted-by":"publisher","DOI":"10.1002\/art.21177"},{"key":"2025090313255060000_10.4.e004494.11","doi-asserted-by":"publisher","DOI":"10.1002\/art.37876"},{"key":"2025090313255060000_10.4.e004494.12","doi-asserted-by":"crossref","DOI":"10.1093\/rap\/rkaa070","article-title":"Persistence of biologic treatments in psoriatic arthritis: a population-based study in Sweden","volume":"4","author":"Geale","year":"2020","journal-title":"Rheumatol Adv Pract"},{"key":"2025090313255060000_10.4.e004494.13","doi-asserted-by":"publisher","DOI":"10.1007\/s10067-017-3593-x"},{"key":"2025090313255060000_10.4.e004494.14","doi-asserted-by":"crossref","DOI":"10.1186\/s13075-021-02417-x","article-title":"Treatment persistence of biologics among patients with psoriatic arthritis","volume":"23","author":"Haddad","year":"2021","journal-title":"Arthritis Res Ther"},{"key":"2025090313255060000_10.4.e004494.15","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2020-217159"},{"key":"2025090313255060000_10.4.e004494.16","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1080\/1744666X.2020.1857733","article-title":"Guselkumab: the first selective IL-23 inhibitor for active psoriatic arthritis in adults","volume":"17","author":"Boehncke","year":"2021","journal-title":"Expert Rev Clin Immunol"},{"key":"2025090313255060000_10.4.e004494.17","unstructured":"Johnson & Johnson . Tremfya (guselkumab) approved by US Food and Drug Administration as the first selective interleukin (IL)-23 inhibitor for active psoriatic arthritis, 2020. Available: https:\/\/www.jnj.com\/tremfya-guselkumab-approved-by-u-s-food-and-drug-administration-as-the-first-selective-interleukin-il-23-inhibitor-for-active-psoriatic-arthritis"},{"key":"2025090313255060000_10.4.e004494.18","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30265-8"},{"key":"2025090313255060000_10.4.e004494.19","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30263-4"},{"key":"2025090313255060000_10.4.e004494.20","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2021-220991"},{"key":"2025090313255060000_10.4.e004494.21","doi-asserted-by":"crossref","unstructured":"Ritchlin CT , Mease PJ , Boehncke WH , et al . AB1104 STRINGENT DISEASE ACTIVITY CONTROL AT 2 YEARS ACROSS PSORIATIC ARTHRITIS DOMAINS IRRESPECTIVE OF BASELINE CHARACTERISTICS IN PATIENTS TREATED WITH GUSELKUMAB: POST-HOC ANALYSIS OF A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY. Ann Rheum Dis 2023;1779\u201380. doi:10.1136\/annrheumdis-2023-eular.3238","DOI":"10.1136\/annrheumdis-2023-eular.3238"},{"key":"2025090313255060000_10.4.e004494.22","doi-asserted-by":"crossref","first-page":"475","DOI":"10.1002\/art.42010","article-title":"Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through two years: results from a phase III, randomized, double-blind, placebo-controlled study conducted in biologic-naive patients with active psoriatic arthritis","volume":"74","author":"McInnes","year":"2022","journal-title":"Arthritis Rheumatol"},{"key":"2025090313255060000_10.4.e004494.23","doi-asserted-by":"crossref","first-page":"423","DOI":"10.1007\/s40744-018-0120-8","article-title":"Skin involvement in psoriatic arthritis worsens overall disease activity, patient-reported outcomes, and increases healthcare resource utilization: an observational, cross-sectional study","volume":"5","author":"de Vlam","year":"2018","journal-title":"Rheumatol Ther"},{"key":"2025090313255060000_10.4.e004494.24","doi-asserted-by":"publisher","DOI":"10.1002\/art.30117"},{"key":"2025090313255060000_10.4.e004494.25","unstructured":"Kavanaugh A , Lam G , Tam L-S , et al . Domains contributing to minimal disease activity non-achievement in patients with psoriatic arthritis receiving golimumab: post hoc analysis of a phase 3, randomized, double-blind, placebo-controlled study. Arthritis Rheumatol 2022;74. Available: https:\/\/acrabstracts.org\/abstract\/domains-contributing-to-minimal-disease-activity-non-achievement-in-patients-with-psoriatic-arthritis-receiving-golimumab-post-hoc-analysis-of-a-phase-3-randomized-double-blind-placebo-controlled\/"},{"key":"2025090313255060000_10.4.e004494.26","doi-asserted-by":"crossref","DOI":"10.1186\/s41927-024-00386-7","article-title":"Efficacy and safety of guselkumab in patients with active psoriatic arthritis who had inadequate efficacy and\/or intolerance to one prior tumor necrosis factor inhibitor: study protocol for SOLSTICE, a phase 3B, multicenter, randomized, double-blind, placebo-controlled study","volume":"8","author":"Ogdie","year":"2024","journal-title":"BMC Rheumatol"},{"key":"2025090313255060000_10.4.e004494.27","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.210349"},{"key":"2025090313255060000_10.4.e004494.28","doi-asserted-by":"crossref","DOI":"10.1186\/s13075-023-03078-8","article-title":"Response to treatment in psoriatic arthritis, the effect of age: analysis of patients receiving ustekinumab in the PsABio real-world study","volume":"25","author":"Gossec","year":"2023","journal-title":"Arthritis Res Ther"},{"key":"2025090313255060000_10.4.e004494.29","doi-asserted-by":"crossref","first-page":"237","DOI":"10.1007\/s40744-020-00202-x","article-title":"The impact of comorbidity on patient-reported outcomes in psoriatic arthritis: a systematic literature review","volume":"7","author":"Ca\u00f1ete","year":"2020","journal-title":"Rheumatol Ther"},{"key":"2025090313255060000_10.4.e004494.30","doi-asserted-by":"crossref","DOI":"10.1136\/rmdopen-2019-000990","article-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","volume":"5","author":"McInnes","year":"2019","journal-title":"RMD Open"},{"key":"2025090313255060000_10.4.e004494.31","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2015-010650","article-title":"Pain mechanisms and ultrasonic inflammatory activity as prognostic factors in patients with psoriatic arthritis: protocol for a prospective, exploratory cohort study","volume":"6","author":"H\u00f8jgaard","year":"2016","journal-title":"BMJ Open"},{"key":"2025090313255060000_10.4.e004494.32","doi-asserted-by":"crossref","DOI":"10.1136\/rmdopen-2020-001240","article-title":"Relationship of pain and fatigue with health-related quality of life and work in patients with psoriatic arthritis on TNFi: results of a multi-national real-world study","volume":"6","author":"Conaghan","year":"2020","journal-title":"RMD Open"}],"container-title":["RMD Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/rmdopen-2024-004494","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,3]],"date-time":"2025-09-03T20:26:01Z","timestamp":1756931161000},"score":1,"resource":{"primary":{"URL":"https:\/\/rmdopen.bmj.com\/lookup\/doi\/10.1136\/rmdopen-2024-004494"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12]]},"references-count":32,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2024,12,12]]},"published-print":{"date-parts":[[2024,12]]}},"alternative-id":["10.1136\/rmdopen-2024-004494"],"URL":"https:\/\/doi.org\/10.1136\/rmdopen-2024-004494","relation":{},"ISSN":["2056-5933"],"issn-type":[{"value":"2056-5933","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,12]]}}}