{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T07:59:07Z","timestamp":1792051147134,"version":"4.4.0"},"reference-count":27,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2025,5,19]],"date-time":"2025-05-19T00:00:00Z","timestamp":1747612800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Registry studies are needed to provide comprehensive and updated assessments of the long\u2010term safety profiles of systemic drugs in psoriasis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To analyse the safety of biologic drugs and new oral molecules used for the treatment of moderate\u2010to\u2010severe psoriasis in patients included in the Spanish Registry of Adverse Events of Biological Therapy (BIOBADADERM), compared to that of adalimumab.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Prospective, multicentre cohort of patients with psoriasis. The safety profiles of biologic agents (etanercept, infliximab, adalimumab, certolizumab, ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab, risankizumab and tildrakizumab), apremilast and dimethyl fumarate were studied. The incidence rate ratio (IRR) and adjusted IRR of specific adverse events were assessed for each drug, using adalimumab as a reference. Propensity scores were used to adjust for selection bias.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Our study included 4212 patients (7590 treatment cycles; 17,284 patient\u2010years of follow\u2010up). Adalimumab had an incidence rate for all adverse events of 614 per 1000 patient\u2010years (95% confidence interval [CI] (591; 637)). The risk of all adverse events was significantly lower for guselkumab (adjusted IRR [aIRR] 0.56, 95% CI (0.47; 0.67)), risankizumab (aIRR 0.59, 95% CI (0.48; 0.71)), tildrakizumab [aIRR 0.6, 95% CI (0.46; 0.8)], ixekizumab (aIRR 0.65, 95% CI (0.56; 0.76)) and ustekinumab (aIRR 0.73 95% CI (0.65; 0.82)) compared to adalimumab (<jats:italic>p<\/jats:italic>\u2009\u2264\u20090.002), as well as the risk for some specific organ\u2010based groups of adverse events. Conversely, the risk for all adverse events was significantly higher for dimethyl fumarate (aIRR 3.67, 95% CI (2.71; 4.97)), infliximab (aIRR 1.88, 95% CI (1.45; 2.43)) (<jats:italic>p<\/jats:italic>\u2009\u2264\u20090.002) and apremilast (aIRR 1.27, 95% CI (1.05; 1.53)) (<jats:italic>p<\/jats:italic> 0.012). The risk of malignant neoplasms was significantly reduced in the group treated with ixekizumab (aIRR 0.14 95% CI (0.04; 0.47)).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our data support that, overall, the new biologic treatments have a superior safety profile in real\u2010world practice compared to adalimumab and its biosimilars.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.20738","type":"journal-article","created":{"date-parts":[[2025,5,19]],"date-time":"2025-05-19T09:19:26Z","timestamp":1747646366000},"page":"1643-1655","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Risk of adverse events of psoriasis treatment with biologic agents and new small molecules\u2014<scp>BIOBADADERM<\/scp> Registry"],"prefix":"10.1111","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-0073-4039","authenticated-orcid":false,"given":"Mar\u00eda","family":"Olivares\u2010Guerrero","sequence":"first","affiliation":[{"name":"Department of Dermatology Hospital Universitario de La Princesa, Instituto de Investigaci\u00f3n Sanitaria de La Princesa (IIS\u2010LP)  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0676-1260","authenticated-orcid":false,"given":"Esteban","family":"Daud\u00e9n","sequence":"additional","affiliation":[{"name":"Department of Dermatology Hospital Universitario de La Princesa, Instituto de Investigaci\u00f3n Sanitaria de La Princesa (IIS\u2010LP)  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josep","family":"Riera\u2010Monroig","sequence":"additional","affiliation":[{"name":"Department of Dermatology Hospital Clinic de Barcelona, UB  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alicia","family":"Gonz\u00e1lez\u2010Quesada","sequence":"additional","affiliation":[{"name":"Department of Dermatology Hospital Universitario de Gran Canaria Dr. Negr\u00edn  Las Palmas de Gran Canaria Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9354-7464","authenticated-orcid":false,"given":"Antonio","family":"Sahuquillo\u2010Torralba","sequence":"additional","affiliation":[{"name":"Department of Dermatology Hospital Universitario y Polit\u00e9cnico La Fe  Valencia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4604-0724","authenticated-orcid":false,"given":"Raquel","family":"Rivera\u2010D\u00edaz","sequence":"additional","affiliation":[{"name":"Department of Dermatology Hospital Universitario 12 de Octubre, Universidad Complutense  Madrid 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of risk of major adverse cardiovascular events with biologic therapy in patients with psoriasis","volume":"16","author":"Bissonnette R","year":"2017","journal-title":"J Drugs Dermatol"},{"key":"e_1_2_14_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2017.07.013"},{"key":"e_1_2_14_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2020.08.032"},{"key":"e_1_2_14_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00403-015-1593-8"},{"key":"e_1_2_14_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.16102"},{"key":"e_1_2_14_25_1","doi-asserted-by":"publisher","DOI":"10.1080\/09546634.2022.2082354"},{"key":"e_1_2_14_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2021.02.057"},{"issue":"7","key":"e_1_2_14_27_1","article-title":"Systemic pharmacological treatments for chronic plaque psoriasis: a network meta\u2010analysis","volume":"7","author":"Sbidian E","year":"2023","journal-title":"Cochrane Database Syst 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