Incidence of selected adverse events in a population-based Danish cohort with atopic dermatitis treated with conventional systemic therapies: a matched case-cohort study.

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  METHOTREXATE (L01BA01 / L04AX03)
• Study drug International non-proprietary name (INN) or common name:
  METHOTREXATE
• Anatomical Therapeutic Chemical (ATC) code:
  (L01BA01) methotrexate

  methotrexate

  (L04AX03) methotrexate

  methotrexate

Population studied

• Short description of the study population:
  Patients with atopic dermatitis (AD) verified by a dermatologist and a background population

Study design details

• Study design:
  This is a retrospective observational cohort register study
• Main study objective:
  PRIMARY OBJECTIVE: ; The primary objective is to quantify the incident rate of major adverse cardiovascular events (MACE) and malignancy (excluding non-melanoma skin cancer (NMSC)) per individual conventional systemic treatment in a dermatologist-verified adult atopic dermatitis (AD) patient population.; SECONDARY OBJECTIVE: ; The secondary objective is to quantify the incident rates of additional adverse events of special interest (All-cause mortality, Arterial thromboembolisms, Venous thromboembolisms, Dyslipidemia, Herpes zoster, NMSC, Serious infections,) per individual conventional systemic treatment in a dermatologist-verified adult atopic dermatitis (AD) patient population.; TERTIARY OBJECTIVE:; The tertiary objective is to compare the above identified incident rates of adverse events per individual conventional systemic treatment in a dermatologist-verified adult atopic dermatitis (AD) patient population with the following two matched cohorts: The Danish background population AND Patients diagnosed with AD not receiving systemic therapies (see section 9.7).