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

• Tác giả: María Teresa Abalde-Pintos, Mariano Ara-Martín, Ofelia Baniandrés-Rodríguez, Isabel Belinchón, José Manuel Carrascosa, Esteban Daudén, Pablo de la Cueva, Elena Del Alcázar, Miguel Ángel Descalzo, Kevin Díez-Madueño, Marta Ferrán, Carmen García-Donoso, Ignacio García-Doval, Francisco José Gómez-García, Alicia González-Quesada, Beatriz González-Sixto, Enrique Herrera-Acosta, Victoria Lezcano-Biosca, Mar Llamas-Velasco, Almudena Mateu, María Olivares-Guerrero, Conrad Pujol-Marco, Josep Riera-Monroig, Raquel Rivera-Díaz, Lourdes Rodríguez, Belén Rodríguez-Sánchez, Mónica Roncero-Riesco, José Carlos Ruiz-Carrascosa, Diana P Ruiz-Genao, Ricardo Ruiz-Villaverde, Antonio Sahuquillo-Torralba, Jorge Suárez-Pérez
• Ngôn ngữ: eng
• Ký hiệu phân loại: 994.02 Period of settlement and growth, 1788-1851
• Thông tin xuất bản: England : Journal of the European Academy of Dermatology and Venereology : JEADV , 2025
• Bộ sưu tập: NCBI
• ID: 749698

Tóm tắt

 BACKGROUND: Registry studies are needed to provide comprehensive and updated assessments of the long-term safety profiles of systemic drugs in psoriasis. OBJECTIVE: 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)). CONCLUSION: Our data support that, overall, the new biologic treatments have a superior safety profile in real-world practice compared to adalimumab and its biosimilars.