{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T18:12:50Z","timestamp":1778523170586,"version":"3.51.4"},"reference-count":31,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T00:00:00Z","timestamp":1778457600000},"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: Guselkumab, a selective anti-IL-23p19 monoclonal antibody, has shown high efficacy in randomized trials for moderate-to-severe psoriasis and active psoriatic arthritis (PsA). Real-world evidence is essential to assess treatment performance in broader and more heterogeneous patient populations. Objectives: To synthesize the available real-world evidence on the effectiveness and safety of guselkumab in psoriasis and PsA, and to quantify pooled clinical responses across clinically relevant follow-up windows. Methods: A systematic review and meta-analysis was conducted according to PRISMA 2020. PubMed\/MEDLINE, MEDLINE, and Web of Science were searched for observational real-world studies of guselkumab in adults with psoriasis and\/or PsA. Primary pooled outcomes were PASI 90 and PASI 100 in psoriasis and DAPSA &lt; 14 in PsA. Random-effects meta-analysis of proportions was performed using a logit transformation. Cohort overlap was explicitly assessed and overlapping publications were not allowed to contribute concurrently to the same pooled estimate. Results: Thirty-four studies were included (29 psoriasis, 5 PsA). In psoriasis, pooled PASI 90 response rates were 50.8% (95% CI 46.8\u201354.8) at 12\u201316 weeks, 68.4% (95% CI 66.3\u201370.4) at 20\u201328 weeks, 71.2% (95% CI 64.9\u201376.8) at 36\u201360 weeks, and 77.1% (95% CI 74.9\u201379.3) at \u226596 weeks. Pooled PASI 100 response rates were 49.8% (95% CI 47.5\u201352.2) at 20\u201328 weeks and 49.7% (95% CI 47.1\u201352.3) at 36\u201360 weeks. In PsA, pooled DAPSA &lt; 14 response rates were 56.9% (95% CI 23.0\u201385.3) at 20\u201328 weeks and 69.5% (95% CI 62.5\u201375.7) at 48\u201360 weeks. Safety reporting was heterogeneous, but serious adverse events and discontinuations due to adverse events were uncommon. Conclusions: Real-world evidence supports guselkumab as an effective treatment for psoriasis and a clinically useful option for PsA, with a safety profile broadly consistent with the known trial experience. Interpretation remains limited by observational designs, heterogeneous denominators, and inconsistent safety reporting.<\/jats:p>","DOI":"10.3390\/jcm15103692","type":"journal-article","created":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T17:17:42Z","timestamp":1778519862000},"page":"3692","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and Safety of Guselkumab in Real-World Evidence: A Systematic Review and Meta-Analysis"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9731-6105","authenticated-orcid":false,"given":"Jose Manuel","family":"Dodero-Anillo","sequence":"first","affiliation":[{"name":"Clinical Pharmacology, Hospital Universitario Puerto Real, 11510 Cadiz, Spain"},{"name":"Pharmacology Department, Faculty of Medicine, University of Cadiz, 11002 Cadiz, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marta","family":"Fernandez-Pujol-Marzo","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Hospital Universitario Puerto Real, 11510 Cadiz, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Jose Pedrosa","family":"Martinez","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Hospital Universitario Puerto Real, 11510 Cadiz, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0381-6174","authenticated-orcid":false,"given":"Ricardo","family":"Ruiz-Villaverde","sequence":"additional","affiliation":[{"name":"Dermatology and Venereology, Hospital Universitario San Cecilio, Instituto Biosanitario de Granada, 18016 Granada, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9919-0486","authenticated-orcid":false,"given":"Jose Carlos","family":"Armario-Hita","sequence":"additional","affiliation":[{"name":"Pharmacology Department, Faculty of Medicine, University of Cadiz, 11002 Cadiz, Spain"},{"name":"Dermatology and Venereology, Hospital Universitario Puerto Real, 11510 Cadiz, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,5,11]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"n71","DOI":"10.1136\/bmj.n71","article-title":"The PRISMA 2020 statement: An updated guideline for reporting systematic reviews","volume":"372","author":"Page","year":"2021","journal-title":"BMJ"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1301","DOI":"10.1016\/S0140-6736(20)32549-6","article-title":"Psoriasis","volume":"397","author":"Griffiths","year":"2021","journal-title":"Lancet"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"545","DOI":"10.1016\/j.rdc.2015.07.001","article-title":"The epidemiology of psoriatic arthritis","volume":"41","author":"Ogdie","year":"2015","journal-title":"Rheum. 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