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.
adverse effects
anti-TNF
anti-inflammatory agents
biologic agents
immunosuppressive agents
long-term follow-up
pharmacovigilance
prospective cohort
psoriasis/drug therapy
registries
safety
Journal
Journal of the American Academy of Dermatology
ISSN: 1097-6787
Titre abrégé: J Am Acad Dermatol
Pays: United States
ID NLM: 7907132
Informations de publication
Date de publication:
Jul 2020
Jul 2020
Historique:
received:
08
10
2019
revised:
05
03
2020
accepted:
08
03
2020
pubmed:
28
3
2020
medline:
22
1
2021
entrez:
28
3
2020
Statut:
ppublish
Résumé
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 <1), whereas cyclosporine and infliximab had the highest, with an increased rate ratio (IRR of ≥5). Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered. Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.
Sections du résumé
BACKGROUND
BACKGROUND
Registry studies broadly describing the safety of systemic drugs in psoriasis are needed.
OBJECTIVE
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
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
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
CONCLUSIONS
Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered.
CONCLUSION
CONCLUSIONS
Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.
Identifiants
pubmed: 32213306
pii: S0190-9622(20)30451-5
doi: 10.1016/j.jaad.2020.03.033
pii:
doi:
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
139-150Investigateurs
Esteban Daudén
(E)
Mar Llamas-Velasco
(M)
Gregorio Carretero
(G)
Jaime Vilar-Alejo
(J)
Raquel Rivera
(R)
Carmen García-Donoso
(C)
Carlos Ferrándiz
(C)
José Manuel Carrascosa
(JM)
Ferrán Ballescá
(F)
Pablo de la Cueva
(P)
Isabel Belinchón
(I)
Fran J Gómez-García
(FJ)
Rafael Jiménez
(R)
Enrique Herrera-Ceballos
(E)
Enrique Herrera-Acosta
(E)
José Luis López-Estebaranz
(JL)
Diana Patricia Ruiz-Genao
(DP)
Marta Ferrán Farrés
(MF)
Mercè Alsina
(M)
Ofelia Baniandrés
(O)
Lula Nieto
(L)
José Luis Sánchez-Carazo
(JL)
Antonio Sahuquillo-Torralba
(A)
Rafael Botella-Estrada
(R)
Conrad Pujol Marco
(CP)
Lourdes Rodríguez Fernández-Freire
(LR)
Almudena Mateu Puchades
(AM)
Ángeles Flórez Menéndez
(ÁF)
Laura Salgado
(L)
Beatriz González Sixto
(BG)
Noemí Eiris
(N)
Ignacio García-Doval
(I)
Miguel Ángel Descalzo Gallego
(MÁ)
Marina de Vega Martínez
(M)
Informations de copyright
Copyright © 2020 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.