000169176 001__ 169176
000169176 005__ 20260223164758.0
000169176 0247_ $$2doi$$a10.1111/jdv.20738
000169176 0248_ $$2sideral$$a145818
000169176 037__ $$aART-2025-145818
000169176 041__ $$aeng
000169176 100__ $$aOlivares-Guerrero, María
000169176 245__ $$aRisk of adverse events of psoriasis treatment with biologic agents and new small molecules-BIOBADADERM Registry
000169176 260__ $$c2025
000169176 5203_ $$aRegistry studies are needed to provide comprehensive and updated assessments of the long‐term safety profiles of systemic drugs in psoriasis.ObjectivesTo analyse the safety of biologic drugs and new oral molecules used for the treatment of moderate‐to‐severe psoriasis in patients included in the Spanish Registry of Adverse Events of Biological Therapy (BIOBADADERM), compared to that of adalimumab.MethodsProspective, 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.ResultsOur study included 4212 patients (7590 treatment cycles; 17,284 patient‐years of follow‐up). Adalimumab had an incidence rate for all adverse events of 614 per 1000 patient‐years (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 (p ≤ 0.002), as well as the risk for some specific organ‐based 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)) (p ≤ 0.002) and apremilast (aIRR 1.27, 95% CI (1.05; 1.53)) (p 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)).ConclusionsOur data support that, overall, the new biologic treatments have a superior safety profile in real‐world practice compared to adalimumab and its biosimilars.
000169176 540__ $$9info:eu-repo/semantics/closedAccess$$aAll rights reserved$$uhttp://www.europeana.eu/rights/rr-f/
000169176 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000169176 700__ $$aDaudén, Esteban
000169176 700__ $$aRiera-Monroig, Josep
000169176 700__ $$aGonzález-Quesada, Alicia
000169176 700__ $$aSahuquillo-Torralba, Antonio
000169176 700__ $$aRivera-Díaz, Raquel
000169176 700__ $$aCarrascosa, José Manuel
000169176 700__ $$aBelinchón, Isabel
000169176 700__ $$aGómez-García, Francisco José
000169176 700__ $$aHerrera-Acosta, Enrique
000169176 700__ $$aRuiz-Genao, Diana P.
000169176 700__ $$aBaniandrés-Rodríguez, Ofelia
000169176 700__ $$aFerrán, Marta
000169176 700__ $$ade la Cueva, Pablo
000169176 700__ $$aRodríguez, Lourdes
000169176 700__ $$aMateu, Almudena
000169176 700__ $$aRuiz-Carrascosa, José Carlos
000169176 700__ $$0(orcid)0000-0001-8789-6783$$aAra-Martín, Mariano$$uUniversidad de Zaragoza
000169176 700__ $$aAbalde-Pintos, María Teresa
000169176 700__ $$aRoncero-Riesco, Mónica
000169176 700__ $$aPujol-Marco, Conrad
000169176 700__ $$aGarcía-Donoso, Carmen
000169176 700__ $$aLlamas-Velasco, Mar
000169176 700__ $$aDel Alcázar, Elena
000169176 700__ $$aSuárez-Pérez, Jorge
000169176 700__ $$aRodríguez-Sánchez, Belén
000169176 700__ $$aDíez-Madueño, Kevin
000169176 700__ $$aRuiz-Villaverde, Ricardo
000169176 700__ $$aLezcano-Biosca, Victoria
000169176 700__ $$aGonzález-Sixto, Beatriz
000169176 700__ $$aDescalzo, Miguel Ángel
000169176 700__ $$aGarcía-Doval, Ignacio
000169176 7102_ $$11007$$2183$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cÁrea Dermatología
000169176 773__ $$g39, 9 (2025), 1643-1655$$pJEADV, J. Eur. Acad. Dermatol. Venereol.$$tJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY$$x0926-9959
000169176 8564_ $$s2716560$$uhttps://zaguan.unizar.es/record/169176/files/texto_completo.pdf$$yVersión publicada
000169176 8564_ $$s2458548$$uhttps://zaguan.unizar.es/record/169176/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000169176 909CO $$ooai:zaguan.unizar.es:169176$$particulos$$pdriver
000169176 951__ $$a2026-02-23-14:53:51
000169176 980__ $$aARTICLE