Population incidence rates of pemphigoid in six European countries

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Pemphigoid

  Mucous membrane pemphigoid

Population studied

• Short description of the study population:
  Pemphigoid patients identified from the European database which cover primary health care users from France, Germany, UK, Spain, Italy and Romania.
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
    • Children (2 to < 12 years)
    • Infants and toddlers (28 days – 23 months)
    • Neonate

      • Term newborn infants (0 – 27 days)
  • 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Pemphigoid patients
• Estimated number of subjects:
  1856

Study design details

• Main study objective:
  To describe the background incidence rate of pemphigoid stratified by age, sex, year of diagnosis and season of diagnosis
• Outcomes:
  new onset of pemphigoid
• Data analysis plan:
  Patients were required to have a minimum observation time of 365 days prior to entering into each period in order to establish whether events observed during the period are incident (first-ever) cases. The study period was from 2015 to 2019. The numerator consisted of the number of patients who experienced new onset of pemphigoid diagnosis during the yearly or quarterly time period. Patients with any recorded baseline history of pemphigoid were excluded and patients were only able to contribute one event each. For the denominator, as with the numerator, patients with a baseline history of pemphigoid at the start of each quarter or year were excluded. Patient follow-up time was truncated at the occurrence of the first event after which they did not contribute to the analysis. Incidence rate = (number of new onset events) / (total follow up time (years)), was calculated for the entire population and stratified by year, season, gender and age.