P Dávila-Seijo1,2,3,4,5,6,7,8,9,10,11,12,13,14,15, E Dauden16, G Carretero17, C Ferrandiz18, F Vanaclocha19, F-J Gómez-García20, E Herrera-Ceballos21, P De la Cueva-Dobao22, I Belinchón23, J-L Sánchez-Carazo24, M Alsina25, J-L López-Estebaranz26, M Ferrán27, R Torrado17, J-M Carrascosa18, M Llamas17, R Rivera20, R Jiménez-Puya21, I García-Doval28,29. 1. Research Unit, Fundación Academia Española de Dermatología y Venereología, Madrid, Spain. pauladavilaseijo@gmail.com. 2. Department of Dermatology, Hospital Universitario La Princesa, Madrid, Spain. pauladavilaseijo@gmail.com. 3. Department of Dermatology, Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria, Spain. pauladavilaseijo@gmail.com. 4. Department of Dermatology, Hospital Universitario Germans Trias i Pujol, Badalona, Spain. pauladavilaseijo@gmail.com. 5. Department of Dermatology, Hospital Universitario 12 de Octubre, Madrid, Spain. pauladavilaseijo@gmail.com. 6. Department of Dermatology, Hospital Universitario Reina Sofía, Córdoba, Spain. pauladavilaseijo@gmail.com. 7. Department of Dermatology, Hospital Universitario Virgen de la Victoria, Málaga, Spain. pauladavilaseijo@gmail.com. 8. Department of Dermatology, Hospital Infanta Leonor, Madrid, Spain. pauladavilaseijo@gmail.com. 9. Department of Dermatology, Hospital General Universitario de Alicante, Alicante, Spain. pauladavilaseijo@gmail.com. 10. Department of Dermatology, Hospital General Universitario de Valencia, Valencia, Spain. pauladavilaseijo@gmail.com. 11. Department of Dermatology, Hospital Clinic de Barcelona, Barcelona, Spain. pauladavilaseijo@gmail.com. 12. Department of Dermatology, Hospital Universitario Fundación Alcorcón, Madrid, Spain. pauladavilaseijo@gmail.com. 13. Department of Dermatology, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain. pauladavilaseijo@gmail.com. 14. Department of Dermatology, Complexo Hospitalario Universitario de Vigo, Vigo, Spain. pauladavilaseijo@gmail.com. 15. Department of Dermatology and Venereology, Umeå University Hospital, Umeå, Sweden. pauladavilaseijo@gmail.com. 16. Department of Dermatology, Hospital Universitario La Princesa, Madrid, Spain. 17. Department of Dermatology, Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria, Spain. 18. Department of Dermatology, Hospital Universitario Germans Trias i Pujol, Badalona, Spain. 19. Department of Dermatology, Hospital Universitario 12 de Octubre, Madrid, Spain. 20. Department of Dermatology, Hospital Universitario Reina Sofía, Córdoba, Spain. 21. Department of Dermatology, Hospital Universitario Virgen de la Victoria, Málaga, Spain. 22. Department of Dermatology, Hospital Infanta Leonor, Madrid, Spain. 23. Department of Dermatology, Hospital General Universitario de Alicante, Alicante, Spain. 24. Department of Dermatology, Hospital General Universitario de Valencia, Valencia, Spain. 25. Department of Dermatology, Hospital Clinic de Barcelona, Barcelona, Spain. 26. Department of Dermatology, Hospital Universitario Fundación Alcorcón, Madrid, Spain. 27. Department of Dermatology, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain. 28. Research Unit, Fundación Academia Española de Dermatología y Venereología, Madrid, Spain. 29. Department of Dermatology, Complexo Hospitalario Universitario de Vigo, Vigo, Spain.
Abstract
BACKGROUND: Few reported studies compare drug survival in moderate-to-severe psoriasis vulgaris. OBJECTIVES: To describe and compare drug survival of systemic drugs, including biologic agents (infliximab, etanercept, adalimumab and ustekinumab) and classical drugs (acitretin, ciclosporin and methotrexate) in moderate-to-severe psoriasis. METHODS: This was a multicenter, prospective, cohort study of patients receiving systemic therapies between 2008 and 2013 in 12 hospitals in Spain. Baseline data and drug discontinuation were collected. Drug survival is presented using Kaplan-Meier survival curves. We compared adjusted risk ratios of serious adverse events (AEs) with results of survival analysis for AEs. RESULTS: A total of 1956 patients were included for analysis (1240 exposed to biologics during follow-up and 1076 to classic therapies). Median follow-up time was 3.3 years (0.0-5.1 years). There were 2209 discontinuations out of 3640 therapy cycles started. The main reason for discontinuation was lack of efficacy (36.4%) and remission (27.2%). Biologics showed a higher drug survival than classics and the pattern of survival results for all outcomes (positive or negative) were very similar. Adjusted risk ratios of serious AEs did not agree with results of survival analysis. LIMITATIONS: A limitation is that this is an observational study with potential selection bias. CONCLUSION: Survival as a proxy measure of drug safety in psoriasis is inadequate.
BACKGROUND: Few reported studies compare drug survival in moderate-to-severe psoriasis vulgaris. OBJECTIVES: To describe and compare drug survival of systemic drugs, including biologic agents (infliximab, etanercept, adalimumab and ustekinumab) and classical drugs (acitretin, ciclosporin and methotrexate) in moderate-to-severe psoriasis. METHODS: This was a multicenter, prospective, cohort study of patients receiving systemic therapies between 2008 and 2013 in 12 hospitals in Spain. Baseline data and drug discontinuation were collected. Drug survival is presented using Kaplan-Meier survival curves. We compared adjusted risk ratios of serious adverse events (AEs) with results of survival analysis for AEs. RESULTS: A total of 1956 patients were included for analysis (1240 exposed to biologics during follow-up and 1076 to classic therapies). Median follow-up time was 3.3 years (0.0-5.1 years). There were 2209 discontinuations out of 3640 therapy cycles started. The main reason for discontinuation was lack of efficacy (36.4%) and remission (27.2%). Biologics showed a higher drug survival than classics and the pattern of survival results for all outcomes (positive or negative) were very similar. Adjusted risk ratios of serious AEs did not agree with results of survival analysis. LIMITATIONS: A limitation is that this is an observational study with potential selection bias. CONCLUSION: Survival as a proxy measure of drug safety in psoriasis is inadequate.
Authors: Ireny Y K Iskandar; Richard B Warren; Mark Lunt; Kayleigh J Mason; Ian Evans; Kathleen McElhone; Catherine H Smith; Nick J Reynolds; Darren M Ashcroft; Christopher E M Griffiths Journal: J Invest Dermatol Date: 2017-12-06 Impact factor: 7.590
Authors: K J Mason; S Williams; Z Z N Yiu; K McElhone; D M Ashcroft; C E Kleyn; Z K Jabbar-Lopez; C M Owen; N J Reynolds; C H Smith; N Wilson; R B Warren; C E M Griffiths Journal: Br J Dermatol Date: 2019-03-27 Impact factor: 9.302