Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

ACITRETIN

Anatomical Therapeutic Chemical (ATC) code

(D05BB02) acitretin
acitretin

Medical condition to be studied

Purpura
Population studied

Short description of the study population

Patient-level characterisations (Objectives 1-2): New users of acitretin in the study period between 01/01/2010 and 31/12/2023 (or the latest date of data availability of the respective databases), with at least 365 days of visibility prior to the date of their first prescription and no prior use of acitretin.
Population-level descriptive epidemiology (Objective 3): New users of acitretin, alternative treatments, and/or diagnosis of a condition of interest in the study period between 01/01/2010 and 31/12/2023 (or the latest date of data availability of the respective databases), with at least 365 days of visibility prior to the date of their first prescription and no prior use of the respective drug/s, will comprise the denominator population based on the respective treatment and indication groups.
Study design details

Study design

• New drug user cohort (Objectives 1-2)
• Population-level descriptive epidemiology (Objective 3)

Main study objective

1. To characterise patients initiating treatment of acitretin in terms of:
a. Demographics
b. Treatment indications
c. Risk factors for purpura and related conditions
d. Comorbidities

2. To describe patient-level acitretin utilisation in a cohort of new users including:
a. Duration of treatment
b. Concomitant medications prescribed at/before/after index date

3. To estimate crude and age-sex standardised incidence rates of purpura and related conditions (and stratified by thrombocytopenic purpura vs non-thrombocytopenic purpura) in patients with common indications for acitretin and/or treatment groups, namely:
a. Treatment: methotrexate, cyclosporine, azathioprine-containing immunosuppressants; acitretin; TNF alpha inhibitors; interleukin inhibitors
b. Indication (psoriasis vs other)
c. Treatment-indication combination: Acitretin-psoriasis, Acitretin-keratinization, Acitretin-unknown/other, Methotrexate-psoriasis, Azathioprine/cyclosporine immunosuppressants-psoriasis, TNF alpha inhibitors-psoriasis, Interleukin inhibitors-psoriasis