Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)

Data collection methods

Combined primary data collection and secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Observational, longitudinal, multicentric, retrospective and prospective study
Study drug and medical condition

Name of medicine, other

ENSTILAR

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

CALCIPOTRIOL
BETAMETHASONE

Medical condition to be studied

Psoriasis
Population studied

Short description of the study population

The study population included patients aged 18 years or older diagnosed with psoriasis received treatment with Enstilar® and/or Daivobet® between April 1, 2018 and May 31, 2022 identified through the THIN® France database.
Inclusion criteria:
1. Patient aged 18 years or more
2. Followed by a panelist physician, GPs or Dermatologists, from the THIN® France database
3. With at least one record of psoriasis diagnosis in their electronic file (ICD10 : L40.0, L40.1, L40.3, L40.8, L40.9)
4. Who received Enstilar® and/or Daivobet® between April 1, 2018 and May 31, 2022

Exclusion criteria:
1. Patients with consultation history less than 3 months prior to inclusion
2. Patients without history reimbursement integrated (HRi) between the 75th and the 105th days before inclusion
3. Patients without any consultation at 3 months or more after inclusion
For the follow-up cohorts:
4. Patients without complete reimbursement history during the 18 months of follow-up

Age groups

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

Other

Special population of interest, other

Patients with psoriasis

Estimated number of subjects

8414
Study design details

Main study objective

The research aim of this study is to better understand the utilization of Enstilar®, compared to Daivobet®, according to patient profile, treatment pathway, and evolution and to characterize the Enstilar® prescription for “beyond-mild” patients in France.

Outcomes

understand the utilization of Enstilar®, compared to Daivobet®, according to patient profile and treatment pathway and outcomes., - to describe through an 18 month follow-up treatment pathway and HRU for patients prescribed with Enstilar® compared to Daivobet®. - to characterize profile of patients with “beyond-mild” psoriasis and under Enstilar®, to assess how they are prescribed with Enstilar® and to describe their follow-up - to better describe psoriasis severity and its impact on quality of life

Data analysis plan

Patients’ characteristics (including demographic characteristics, comorbidities and concomitant treatment) at inclusion will be compared between patients being under Enstilar® versus Daivobet®. Summary statistics (mean, median, SD, quartile, 3rd quartile, range for continuous variables and number of patients and percentages) will be calculated overall and per treatment group. Univariate comparisons will be performed using Chi-square (or Fisher) test and Student (or Wilcoxon) test as appropriate according to the class of the variable of interest. Follow-up cohort: descriptive analyses of HRU and treatment patterns will be carried out in the two groups (Enstilar® versus Daivobet®). Second, time to switch to other psoriasis treatment in the two groups will be described using Kaplan Meier curve and compared using propensity score method to adjust on differences observed at baseline (delivery of Enstilar® of Daivobet®).