{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T23:36:33Z","timestamp":1790984193958,"version":"4.1.0"},"reference-count":36,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2025,6,10]],"date-time":"2025-06-10T00:00:00Z","timestamp":1749513600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background\/Objectives: Psoriatic arthritis (PsA) is a chronic inflammatory condition that primarily affects the musculoskeletal system and skin. While biologic and targeted synthetic DMARDs have improved treatment, many patients still fail to achieve remission. Combining conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) with biologic (b) DMARDs or targeted synthetic (ts) DMARDs shows no added benefit over monotherapy with IL-17, IL-23 inhibitors, or JAK inhibitors, unlike TNFi, which benefit from csDMARD co-administration. Guselkumab (GUS) and risankizumab (RKZ) target IL-23 with high specificity. RCTs (DISCOVER 1 and 2, COSMOS) have confirmed GUS efficacy regardless of methotrexate (MTX) use, though liver toxicity was higher with MTX. Real-world data on GUS remain limited, with gaps in understanding its long-term effectiveness and drug survival. The aim of this study is to assess the following three points within a multicenter Italian real-life cohort of PsA patients treated with guselkumab (GUS) and followed for 12 months: (1) effectiveness and safety of GUS; (2) drug retention rate (DRR) and reasons for discontinuation; (3) impact of comorbidities on achieving minimal disease activity (MDA). Methods: This study utilized data from the GISEA registry, which includes centers in different parts of Italy (north, center, south, and islands), and included patients aged 18 and older diagnosed with PsA according to the CASPAR criteria. Results: Data on 170 PsA patients treated with GUS were collected. In the first 6 months, a prompt mean percentage improvement in all clinimetric indexes was observed compared to the baseline. At 6-month follow-up, ACR 20 was reached by 60% of patients, ACR 50 by 30%, ACR 70 by 15%, MDA by 28%, and DAPSA &lt; 14 by 50% of patients in the overall group. Significant differences were found in the rate of ACR 50 in the bDMARD-naive group (50%) compared to one bDMARDs non-responder (NR) (8%) (p = 0.021). At 12-month follow-up, a notable gap was observed in the rate of patients reaching MDA between bDMARD-naive (60%) and one bDMARDs NR (22%) (p = 0.035) and between bDMARD-naive (60%) and \u22652 bDMARDs NRs (22%) (p = 0.024). By using multivariate binary logistic analysis, the predictors of reaching MDA at 12-month follow-up were naive bDMARDs (OR: 7.9, 95% CI: 1.3\u201344.8, p = 0.019) and a higher value of pGA at baseline (OR: 1.1, 95% CI: 1\u20131.5; p = 0.046). The presence of comorbidities, including fibromyalgia and obesity, did not seem to affect the reaching of MDA. At 12-month follow-up, the GUS retention rate was 76%, with a mean survival time of 10.5 months \u00b1 0.2 (95% CI: 10\u201310.9). No significant differences in GUS survival time were found among bDMARD-naive, one bDMARDs NR, and \u22652 bDMARDs NR patients (in the latter, regardless of the previous mechanism of action: TNFi or other mechanism), as well as between patients treated with GUS in monotherapy and those treated in combination with csDMARDs. A low rate (17%) of discontinuation was found due to both primary NR and secondary NR. The high safety of GUS was recorded. In fact, discontinuation due to adverse events (all definable as minor) was observed in just 4% of patients. By using COX regression multivariate analysis, the factors associated with higher GUS discontinuation risk were a more severe baseline PASI (HR: 1.05, 95% CI: 1\u20131.1, p = 0.038) and higher baseline ESR (HR:1.06, 95% CI: 1\u20131.03, p = 0.05). Conclusions: Good performance of GUS was observed in both biologic-naive patients and those with failure of previous bDMARDs (regardless of the mechanism of action of the previous drug: TNFi or non-TNFi), presenting good persistence in therapy even when used as a third mechanism of action. Its high safety profile allows the use of GUS even in particularly complex patients.<\/jats:p>","DOI":"10.3390\/jcm14124111","type":"journal-article","created":{"date-parts":[[2025,6,10]],"date-time":"2025-06-10T09:59:14Z","timestamp":1749549554000},"page":"4111","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Italian Multicenter Real-World Study on the Twelve-Month Effectiveness, Safety, and Retention Rate of Guselkumab in Psoriatic Arthritis Patients"],"prefix":"10.3390","volume":"14","author":[{"given":"Fabiola","family":"Atzeni","sequence":"first","affiliation":[{"name":"Rheumatology Unit, Department of Experimental and Internal Medicine, University of Messina, 98168 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1356-8423","authenticated-orcid":false,"given":"Cinzia","family":"Rotondo","sequence":"additional","affiliation":[{"name":"Rheumatology Unit, Department of Medical and Surgical Sciences, Azienda Ospedaliero-Universitaria Policlinico Riuniti di Foggia, Universit\u00e0 degli Studi di Foggia, 71122 Foggia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cesare","family":"Siragusano","sequence":"additional","affiliation":[{"name":"Rheumatology Unit, Department of Experimental and Internal Medicine, University of Messina, 98168 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Addolorata","family":"Corrado","sequence":"additional","affiliation":[{"name":"Rheumatology Unit, Department of Medical and Surgical Sciences, Azienda Ospedaliero-Universitaria Policlinico Riuniti di Foggia, Universit\u00e0 degli Studi di Foggia, 71122 Foggia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto","family":"Cauli","sequence":"additional","affiliation":[{"name":"Rheumatology Unit, Department of Medical Science and Public Health, The University Hospital (AOU), University of Cagliari, 09042 Monserrato, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Caporali","sequence":"additional","affiliation":[{"name":"Rheumatology Unit, Dipartimento di Reumatologia e Scienze Mediche, ASST PINI-CTO, 20122 Milan, Italy"},{"name":"Rheumatology Unit, Dipartimento di Scienze Cliniche e di Comunit\u00e0, University of Milan, 20122 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1343-1729","authenticated-orcid":false,"given":"Maria Sole","family":"Chimenti","sequence":"additional","affiliation":[{"name":"Rheumatology, Allergology and Clinical Immunology, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabrizio","family":"Conti","sequence":"additional","affiliation":[{"name":"Rheumatology Unit, Department of Clinical Internal, Anesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, 00184 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valentina","family":"Picerno","sequence":"additional","affiliation":[{"name":"Rheumatology Department of Lucania, Rheumatology Institute of Lucania (IReL), San Carlo Hospital of Potenza, 75100 Potenza, Italy"},{"name":"Rheumatology Department of Lucania, Rheumatology Institute of Lucania (IReL), Madonna Delle Grazie Hospital of Matera, 75100 Matera, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2248-1058","authenticated-orcid":false,"given":"Elisa","family":"Gremese","sequence":"additional","affiliation":[{"name":"Rheumatology and Clinical Immunology, IRCCS Humanitas Research Hospital, 20089 Rozzano, Italy"},{"name":"Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20090 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Camarda","sequence":"additional","affiliation":[{"name":"Rheumatology Unit, University of Palermo, 90133 Palermo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2722-6475","authenticated-orcid":false,"given":"Serena","family":"Guiducci","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Department of Experimental and Clinical Medicine, University of Florence, 50139 Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9683-8873","authenticated-orcid":false,"given":"Roberta","family":"Ramonda","sequence":"additional","affiliation":[{"name":"Rheumatology Unit, Department of Medicine DIMED, University of Padua, 35131 Padua, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7254-4686","authenticated-orcid":false,"given":"Luca","family":"Idolazzi","sequence":"additional","affiliation":[{"name":"Rheumatology Unit, Department of Medicine, University of Verona, 37134 Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelo","family":"Semeraro","sequence":"additional","affiliation":[{"name":"Rheumatology Unit, Martina Franca Hospital, 74015 Martina Franca, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1294-6421","authenticated-orcid":false,"given":"Marco","family":"Sebastiani","sequence":"additional","affiliation":[{"name":"Rheumatology Unit, AUSL Piacenza, University of Parma, 43126 Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8427-6092","authenticated-orcid":false,"given":"Giovanni","family":"Lapadula","sequence":"additional","affiliation":[{"name":"GISEA Group, 20100 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gianfranco","family":"Ferraccioli","sequence":"additional","affiliation":[{"name":"Department of Medicine, Catholic University Sacred Heart\u2014FPG, 00168 Roma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0474-5344","authenticated-orcid":false,"given":"Florenzo","family":"Iannone","sequence":"additional","affiliation":[{"name":"Rheumatology Unit, DiMePRe-J, University of Bari, 70124 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,6,10]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"957","DOI":"10.1056\/NEJMra1505557","article-title":"Psoriatic Arthritis","volume":"376","author":"Ritchlin","year":"2017","journal-title":"N. 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Arthritis Rheum."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"48","DOI":"10.1136\/ard.2008.102053","article-title":"Defining minimal disease activity in psoriatic arthritis: A proposed objective target for treatment","volume":"69","author":"Coates","year":"2010","journal-title":"Ann. Rheum. Dis."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"e003423","DOI":"10.1136\/rmdopen-2023-003423","article-title":"Evaluating the efficacy of biologics with and without methotrexate in the treatment of psoriatic arthritis: A network meta-analysis","volume":"10","author":"Mease","year":"2024","journal-title":"RMD Open"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"S12","DOI":"10.1002\/msc.1694","article-title":"The role of IL-23 and the use of IL-23 inhibitors in psoriatic arthritis","volume":"20","author":"Fragoulis","year":"2022","journal-title":"Musculoskelet. Care"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"1126","DOI":"10.1016\/S0140-6736(20)30263-4","article-title":"Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): A double-blind, randomised, place-bo-controlled phase 3 trial","volume":"395","author":"Mease","year":"2020","journal-title":"Lancet"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"225","DOI":"10.1136\/annrheumdis-2021-221019","article-title":"Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial","volume":"81","author":"Kristensen","year":"2022","journal-title":"Ann. Rheum. 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Dis."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/12\/4111\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T17:49:32Z","timestamp":1760032172000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/12\/4111"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6,10]]},"references-count":36,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2025,6]]}},"alternative-id":["jcm14124111"],"URL":"https:\/\/doi.org\/10.3390\/jcm14124111","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6,10]]}}}