Esteban Daudén1, Gregorio Carretero2, Raquel Rivera3, Carlos Ferrándiz4, Mar Llamas-Velasco5, Pablo de la Cueva6, Isabel Belinchón7, Francisco José Gómez-García8, Enrique Herrera-Acosta9, Diana Patricia Ruiz-Genao10, Marta Ferrán-Farrés11, Mercè Alsina12, Ofelia Baniandrés-Rodríguez13, José Luis Sánchez-Carazo14, Antonio Sahuquillo-Torralba15, Lourdes Rodriguez Fernández-Freire16, Jaime Vilar-Alejo2, Carmen García-Donoso3, José Manuel Carrascosa4, Enrique Herrera-Ceballos9, José Luis López-Estebaranz10, Rafael Botella-Estrada17, Eva Segovia-Muñoz18, Miguel Angel Descalzo19, Ignacio García-Doval20. 1. Department of Dermatology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria de La Princesa (IIS-IP), Madrid, Spain. Electronic address: estebandauden@gmail.com. 2. Department of Dermatology, Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria, Spain. 3. Department of Dermatology, Hospital Universitario 12 de Octubre, Madrid, Spain. 4. Department of Dermatology, Hospital Universitari Germans Trias i Pujol, Badalona, and Universidad Autónoma de Barcelona, Badalona, Spain. 5. Department of Dermatology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria de La Princesa (IIS-IP), Madrid, Spain. 6. Department of Dermatology, Hospital Universitario Infanta Leonor, Madrid, Spain. 7. Department of Dermatology, Hospital General Universitario de Alicante, Alicante, Spain. 8. Department of Dermatology, Hospital Universitario Reina Sofía, Cordoba, Spain. 9. Department of Dermatology, Hospital Universitario Virgen de la Victoria, Málaga, Spain. 10. Department of Dermatology, Hospital Universitario Fundación Alcorcón, Madrid, Spain. 11. Department of Dermatology, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain. 12. Department of Dermatology, Hospital Clínic de Barcelona, UB, Barcelona, Spain. 13. Department of Dermatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain. 14. Department of Dermatology, Hospital General Universitario de Valencia, Valencia, Spain. 15. Department of Dermatology, Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe (IIS La Fe), Valencia, Spain. 16. Department of Dermatology, Hospital Virgen del Rocío, Sevilla, Spain. 17. Department of Dermatology, Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe (IIS La Fe), Universidad de Valencia, Valencia, Spain. 18. Evaluation Unit, Pharmacovigilance Department, Spanish Medicines and Health Products Agency (AEMPS), Madrid, Spain. 19. Research Unit, Fundación Piel Sana Academia Española de Dermatología, Madrid, Spain. 20. Research Unit, Fundación Piel Sana Academia Española de Dermatología, Madrid, Spain; Department of Dermatology, Complexo Hospitalario Universitario de Vigo, Vigo, Spain.
Abstract
BACKGROUND: Registry studies broadly describing the safety of systemic drugs in psoriasis are needed. OBJECTIVE: 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. METHODS: 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. RESULTS: 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 <1), whereas cyclosporine and infliximab had the highest, with an increased rate ratio (IRR of ≥5). LIMITATIONS: Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered. CONCLUSION: Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.
BACKGROUND: Registry studies broadly describing the safety of systemic drugs in psoriasis are needed. OBJECTIVE: 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. METHODS: 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. RESULTS: 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 <1), whereas cyclosporine and infliximab had the highest, with an increased rate ratio (IRR of ≥5). LIMITATIONS: Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered. CONCLUSION: Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.
Authors: J Beecker; K A Papp; J Dutz; R B Vender; R Gniadecki; C Cooper; P Gisondi; M Gooderham; C H Hong; M G Kirchhof; C W Lynde; C Maari; Y Poulin; L Puig Journal: J Eur Acad Dermatol Venereol Date: 2021-02-03 Impact factor: 6.166
Authors: Cristina Membrive Jiménez; Cristina Pérez Ramírez; Almudena Sánchez Martín; Sayleth Vieira Maroun; Salvador Antonio Arias Santiago; María Del Carmen Ramírez Tortosa; Alberto Jiménez Morales Journal: J Pers Med Date: 2021-04-12