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Given that many patients with PsA are TNFi inadequate responders (TNF-IR; either inadequate efficacy or intolerance), treatments utilizing alternative mechanisms of action are needed. In phase 3 studies, the fully human \ufeffinterleukin (IL)-23p19 subunit-inhibitor, guselkumab, was efficacious in patients with active PsA, including TNFi-IR. Efficacy was generally consistent between TNFi-na\u00efve and TNFi-experienced cohorts; however, in the latter, higher response rates have been observed with the Q4W dosing regimen relative to the Q8W dosing regimen for some endpoints, suggesting the need to evaluate whether more frequent dosing may provide an incremental clinical benefit for TNFi-IR patients.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>The phase 3b SOLSTICE study will assess guselkumab efficacy and safety in TNFi-IR PsA patients. Eligibility criteria include a PsA diagnosis for\u2009\u2265\u20096\u00a0months; active disease (\u2265\u20093 swollen,\u2009\u2265\u20093 tender joints, C-reactive protein \u2265\u20090.3\u00a0mg\/dL); and inadequate efficacy with, and\/or intolerance to, one prior TNFi. Participants will be randomized 1:1:1 to guselkumab Q4W or Q8W or placebo\u2192guselkumab\ufeff Q4W (at Week 24). The primary endpoint is the proportion of patients achieving\u2009\u2265\u200920% improvement in the American College of Rheumatology criteria (ACR20) at Week 24. Major secondary endpoints include ACR50, ACR70; an Investigator\u2019s Global Assessment (IGA) of psoriasis score of 0\/1 plus\u2009\u2265\u20092-grade reduction and\u2009\u2265\u200990% improvement in Psoriasis Area and Severity Index (both among patients with\u2009\u2265\u20093% body surface area affected by psoriasis and baseline IGA\u2009\u2265\u20092); minimal\/very low disease activity; and changes from baseline in Health Assessment Questionnaire-Disability Index, the 36-item Short-Form\ufeff Health Survey\u00a0Physical Component Summary, and Functional Assessment of Chronic Illness Therapy-Fatigue scores. The target sample size (<jats:italic>N<\/jats:italic>\u2009=\u2009450) is estimated to provide\u2009&gt;\u200990% power in detecting differences between each guselkumab group and the placebo group for the primary endpoint assuming a 2-sided \u03b1\u2009=\u20090.05. Cochran-Mantel\u2013Haenszel testing and analyses of covariance will\ufeff be used to\u00a0compare efficacy for binary and continuous endpoints, respectively.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>Findings from the phase 3b SOLSTICE study, the design of which was informed by results from previously conducted phase 3 studies, is expected to provide important efficacy and safety information on guselkumab therapy in TNFi-IR patients with PsA.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>This trial was registered at ClinicalTrials.gov, NCT04936308, on 23 June 2021.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s41927-024-00386-7","type":"journal-article","created":{"date-parts":[[2024,5,21]],"date-time":"2024-05-21T06:01:56Z","timestamp":1716271316000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"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"],"prefix":"10.1186","volume":"8","author":[{"given":"Alexis","family":"Ogdie","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph F.","family":"Merola","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philip J.","family":"Mease","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher T.","family":"Ritchlin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jose U.","family":"Scher","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kimberly Parnell","family":"Lafferty","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daphne","family":"Chan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Soumya D.","family":"Chakravarty","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wayne","family":"Langholff","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yanli","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olivia","family":"Choi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yevgeniy","family":"Krol","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alice B.","family":"Gottlieb","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,5,21]]},"reference":[{"key":"386_CR1","doi-asserted-by":"publisher","first-page":"957","DOI":"10.1056\/NEJMra1505557","volume":"376","author":"CT Ritchlin","year":"2017","unstructured":"Ritchlin CT, Colbert RA, Gladman DD. 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Trials. 2023;24:22.","journal-title":"Trials"}],"container-title":["BMC Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s41927-024-00386-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s41927-024-00386-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s41927-024-00386-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,21]],"date-time":"2024-05-21T07:09:00Z","timestamp":1716275340000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcrheumatol.biomedcentral.com\/articles\/10.1186\/s41927-024-00386-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5,21]]},"references-count":48,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["386"],"URL":"https:\/\/doi.org\/10.1186\/s41927-024-00386-7","relation":{},"ISSN":["2520-1026"],"issn-type":[{"value":"2520-1026","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5,21]]},"assertion":[{"value":"14 August 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 April 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 May 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study is being conducted in compliance with the Declaration of Helsinki and International Council for Harmonization Guidelines for Good Clinical Practice. The study was approved by Sterling Institutional Review Board for most sites in the United States (full list available in the ). Prior to participation in any study-related procedures, patients will provide written informed consent; additional consent will be collected for optional pharmacogenomic analyses.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"AO has received grant\/research support to the University of Pennsylvania from AbbVie, Janssen, Novartis, and Pfizer and to Forward from Amgen; consultant fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, CorEvitas, Eli Lilly, Gilead, Happify Health, Janssen, Novartis, Pfizer, and UCB; Dr. Ogdie\u2019s husband has received royalties from Novartis.JFM has received consulting fees and investigator honoraria from AbbVie, Amgen, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly, Incyte, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB.\u00a0JFM was affiliated with Brigham and Women\u2019s Hospital, Harvard Medical School when this worked was performed; current affiliation is now Department of Dermatology, and Department of Medicine, Division of Rheumatology, UT Southwestern Medical Center, Dallas, TX, USA.PJM has received research grants from AbbVie, Acelyrin, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, SUN, and UCB; consulting fees from AbbVie, Acelyrin, Aclaris, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Immagene, Janssen, Novartis, Pfizer, SUN, UCB, Ventyx; speaker fees from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB.CTR has received grant\/research support from AbbVie, Amgen, and UCB; and consulting fees from Amgen, AbbVie, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB.JUS has received consulting fees for AbbVie, Janssen, Novartis, Pfizer, Sanofi, Kaleido and UCB; and funding for investigator-initiated studies from Novartis, Pfizer and Janssen.ABG has received honoraria as an advisory board member and consultant for Amgen, AnaptypsBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dice Therapeutics, Eli Lilly, Janssen, Novartis, Sanofi, Teva,\u00a0UCB, and Xbiotech and has received research\/educational grants from Bristol Myers Squibb, Highlights Therapeutics, Janssen, and UCB (all paid to Mount Sinai School of Medicine).KPL, DC, SDC, OC, and YK are employees of Janssen Scientific Affairs, LLC and own stock in Johnson & Johnson. WL is an employee of Janssen Research & Development, LLC and owns stock in Johnson & Johnson. YW is employee of IQVIA providing statistical support (funded by Janssen).","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"20"}}