Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry

Registry studies broadly describing the safety of systemic drugs in psoriasis are needed. To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to se...

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Published in:Journal of the American Academy of Dermatology 2020-07, Vol.83 (1), p.139-150
Main Authors: Daudén, Esteban, Carretero, Gregorio, Rivera, Raquel, Ferrándiz, Carlos, Llamas-Velasco, Mar, de la Cueva, Pablo, Belinchón, Isabel, Gómez-García, Francisco José, Herrera-Acosta, Enrique, Ruiz-Genao, Diana Patricia, Ferrán-Farrés, Marta, Alsina, Mercè, Baniandrés-Rodríguez, Ofelia, Sánchez-Carazo, José Luis, Sahuquillo-Torralba, Antonio, Fernández-Freire, Lourdes Rodriguez, Vilar-Alejo, Jaime, García-Donoso, Carmen, Carrascosa, José Manuel, Herrera-Ceballos, Enrique, López-Estebaranz, José Luis, Botella-Estrada, Rafael, Segovia-Muñoz, Eva, Descalzo, Miguel Angel, García-Doval, Ignacio, Ballescá, Ferrán, Cueva, Pablo de la, Gómez-García, Fran J., Jiménez, Rafael, Farrés, Marta Ferrán, Baniandrés, Ofelia, Nieto, Lula, Marco, Conrad Pujol, Fernández-Freire, Lourdes Rodríguez, Puchades, Almudena Mateu, Menéndez, Ángeles Flórez, Salgado, Laura, Sixto, Beatriz González, Eiris, Noemí, Descalzo Gallego, Miguel Ángel, de Vega Martínez, Marina
Format: Article
Language:English
Subjects:
Adult
adverse effects
Aged
anti-inflammatory agents
anti-TNF
biologic agents
Biological Therapy - adverse effects
Cohort Studies
Female
Humans
immunosuppressive agents
long-term follow-up
Male
Middle Aged
pharmacovigilance
prospective cohort
Psoriasis - drug therapy
Registries
safety
Spain
Time Factors
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Summary:Registry studies broadly describing the safety of systemic drugs in psoriasis are needed. To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry. The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort. Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of
ISSN:0190-9622
1097-6787
DOI:10.1016/j.jaad.2020.03.033