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Multicenter Study
. 2025 Sep;39(9):1643-1655.
doi: 10.1111/jdv.20738. Epub 2025 May 19.

Risk of adverse events of psoriasis treatment with biologic agents and new small molecules-BIOBADADERM Registry

María Olivares-Guerrero  1 , Esteban Daudén  1 , Josep Riera-Monroig  2 , Alicia González-Quesada  3 , Antonio Sahuquillo-Torralba  4 , Raquel Rivera-Díaz  5 , José Manuel Carrascosa  6 , Isabel Belinchón  7 , Francisco José Gómez-García  8 , Enrique Herrera-Acosta  9 , Diana P Ruiz-Genao  10 , Ofelia Baniandrés-Rodríguez  11 , Marta Ferrán  12 , Pablo de la Cueva  13 , Lourdes Rodríguez  14 , Almudena Mateu  15 , José Carlos Ruiz-Carrascosa  16 , Mariano Ara-Martín  17 , María Teresa Abalde-Pintos  18 , Mónica Roncero-Riesco  19 , Conrad Pujol-Marco  4 , Carmen García-Donoso  5 , Mar Llamas-Velasco  1 , Elena Del Alcázar  6 , Jorge Suárez-Pérez  9 , Belén Rodríguez-Sánchez  11 , Kevin Díez-Madueño  13 , Ricardo Ruiz-Villaverde  16 , Victoria Lezcano-Biosca  17 , Beatriz González-Sixto  18 , Miguel Ángel Descalzo  20 , Ignacio García-Doval  20   21
Affiliations
Multicenter Study

Risk of adverse events of psoriasis treatment with biologic agents and new small molecules-BIOBADADERM Registry

María Olivares-Guerrero et al. J Eur Acad Dermatol Venereol. 2025 Sep.

Abstract

Background: Registry studies are needed to provide comprehensive and updated assessments of the long-term safety profiles of systemic drugs in psoriasis.

Objectives: To 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.

Methods: 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.

Results: Our 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)).

Conclusions: Our data support that, overall, the new biologic treatments have a superior safety profile in real-world practice compared to adalimumab and its biosimilars.

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References

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