Spanish Registry of Atopic Dermatitis (BIOBADATOP)

Study type

• Study topic:
  Disease /health condition
• Study topic, other:
  Atopic dermatitis
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ADTRALZA

  CIBINQO

  DUPIXENT

  OLUMIANT

  RINVOQ
• Name of medicine, other:
  methotrexate, cyclosporine, azathioprine
• Anatomical Therapeutic Chemical (ATC) code:
  (D11AH05) dupilumab

  dupilumab

  (L04A) IMMUNOSUPPRESSANTS

  IMMUNOSUPPRESSANTS
• Medical condition to be studied:
  Dermatitis atopic

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)
• Estimated number of subjects:
  2000

Study design details

• Study design:
  Inception cohort of patients receiving systemic therapy for atopic dermatitis.
• Main study objective:
  The main objectives are:1. To assess short and long-term safety of systemic therapies (including phototherapy) for atopic eczema (pharmacovigilance).2. To assess short and long-term effectiveness of systemic therapies, providing a basis for shared decision making and guidelines.
• Setting:
  Dermatology departments in Spain.
• Outcomes:
  Treatment safety (pharmacovigilance): we will still be able to conduct a meaningful descriptive analysis of more common AEs and SAEs collected over an at least one-year period for each treatment modality.Treatment effectiveness: Effectiveness of the study medications will be assessed using objective measures (EASI) and patient-reported outcomes (POEMS).
• Data analysis plan:
  The initial analyses will consist of comparisons in baseline status between the individuals in the treatment cohorts. For the purposes of analysis follow-up time will be start with enter in the cohort or first dose of a drug and will end at the earliest of the following: exiting the register, loss to follow-up, enter in a clinical trial, death or end of study period. Incidence rates for patients initiating new treatments and initiating other conventional systemic therapies will be estimated crude and stratified by confounding factors. Then time-dependent regression analyses will be undertaken to compare event rates between groups, using standard multivariable analyses to reduce confounding. We will use other statistical techniques, including propensity score matching, to accommodate confounding by indication. As children and adolescents may have a different phenotype of AE compared to adults and may respond differently to systemic therapy, we will explore this by stratifying groups.