Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(D05BB02) acitretin
acitretin
(L04AB) Tumor necrosis factor alpha (TNF-alpha) inhibitors
Tumor necrosis factor alpha (TNF-alpha) inhibitors
(L04AC05) ustekinumab
ustekinumab
(L04AD01) ciclosporin
ciclosporin
(L04AX03) methotrexate
methotrexate

Medical condition to be studied

Psoriasis
Population studied

Age groups

Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Hepatic impaired
Immunocompromised
Pregnant women
Renal impaired

Estimated number of subjects

3000
Study design details

Main study objective

To describe safety of systemic drugs used in psoriasis

Outcomes

Serious Adverse Events Time Frame: an expected mean follow-up of 5 years , Other adverse events leading to changes in drug therapy or unexpected visits to health provider Time Frame: an expected mean follow-up of 5 years

Data analysis plan

Analysis consists of description of rates, rate ratios and adjusted rate ratios (adjusted for possible confounders, age always included).
Documents
Study publications
Garcia-Doval I, Carretero G, Vanaclocha F, Ferrandiz C, Daudén E, Sánchez-Caraz…
Sánchez‐Moya, A.I., García‐Doval, I., Carretero, G., Sánchez‐Carazo, J., Ferran…
Carrascosa JM, Vilavella M, Garcia‐Doval I, Carretero G, Vanaclocha F, Daudén E…
Carretero G, Ferrandiz C, Dauden E, Vanaclocha Sebastian F, Gómez‐García FJ, He…
Medina C, Carretero G, Ferrandiz C, Dauden E, Vanaclocha F, Gómez‐García FJ, He…