Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation
Safety study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine, other

Topical tacrolimus
Topical pimecrolimus

Anatomical Therapeutic Chemical (ATC) code

(D11AH01) tacrolimus
tacrolimus
(D11AH02) pimecrolimus
pimecrolimus

Medical condition to be studied

Malignant melanoma
Hodgkin's disease
Non-Hodgkin's lymphoma
Neoplasm skin
Population studied

Short description of the study population

All individuals of any age registered in the study databases from the date topical tacrolimus became available in each country through December 31, 2011.

Eligibility Criteria
To be eligible for inclusion in the study population, individuals should have at least 12 months of continuous enrollment in the study databases, except for children 0 to 12 months of age. Thus, a person becomes eligible for study inclusion the day after this 12-month enrollment period has been completed (eligibility date) or, for children 0 to 12 months of age, from the date of enrollment in the database. The eligibility date can occur before or during the study period.
Because the study is focused on incident cases of skin cancer and lymphoma, patients with a history of any of these conditions any time before the start date (date of cohort entry) will be excluded from the study population.

Age groups

  • Paediatric Population (< 18 years)
    • Neonate
      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

195931
Study design details

Main study objective

To estimate the incidence rate ratios of skin cancer and lymphoma in the pediatric and adult populations for new users of topical tacrolimus and topical pimecrolimus compared with users of moderate- to high-potency topical corticosteroids diagnosed with atopic dermatitis.

Outcomes

Skin Malignancies: Malignant melanoma, Nonmelanoma skin cancer,
Lymphomas: Cutaneous T cell lymphomas (CTCL), Hodgkin lymphomas (HL), Non-Hodgkin lymphomas

Data analysis plan

Incidence rates of each study malignancy will be estimated in users of topical tacrolimus, topical pimecrolimus, moderate- to high-potency topical corticosteroids, and in the general population. Incidence rate ratios and 95% CIs will be estimated comparing the rates between users of topical tacrolimus and topical pimecrolimus and users of moderate- to high-potency corticosteroids, and between users of moderate- to high-potency corticosteroids and the general population. Propensity scores will be used to match the study cohorts. Each research center will produce stratified data that will be analysed by the coordination center using standard stratified methods. The effect of cumulative dose and duration of use of topical tacrolimus and topical pimecrolimus will be estimated.