Italian healthcare resource consumptions and direct costs of adults with atopic dermatitis before and after dupilumab treatment

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Healthcare resource utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  DUPIXENT
• Study drug International non-proprietary name (INN) or common name:
  DUPILUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (D11AH05) dupilumab

  dupilumab
• Medical condition to be studied:
  Dermatitis atopic
• Additional medical condition(s):
  Severe atopic dermatitis

Population studied

• Short description of the study population:
  Adults with at least one supply of dupilumab (ATC code D11AH05) from 1st September 2018 to 1st December 2020, with a five-year lookback period and until 31st December 2020. Given that, in Italy, the reimbursement of dupilumab for adult patients was granted to severe AD (eligibility criteria: EASI score ≥24 who have failed or are inadvisable for the treatment with cyclosporine) until the beginning of December 2020, the dispensation of dupilumab during the accrual period, from 1st September 2018 to 1st December 2020, was used as the specific inclusion criterion to identify patients with AD (namely, the only indication reimbursed at that time).
• Age groups:
  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:
  337

Study design details

• Study design:
  Adults treated with dupilumab from 09/01/2018 to 31/12/2020 (index date) were identified. Age, sex and comorbidities during a five-year lookback period, concomitant drugs, overnight hospitalization, outpatient specialist services and direct costs charged to the SSN one year before/after index date
• Main study objective:
  This study assessed the burden before and after treatment with dupilumab in adults with severe AD from 2018 to 2020, from the perspective of the Italian National Health Service (SSN).
• Setting:
  Inpatient and local outpatient
• Summary results:
  Of 337 adults treated with dupilumab (5.8x100,000 adult inhabitants/2019; 8.0x100,000/2020; 55% males; mean age 43±19), 68% (228/337) had ≥12-month follow-up available. Asthma was a common comorbidity (23% patients). Rates of patients treated with nearly all concomitant AD-related therapies reduced from 12 months before to 12 months after dupilumab treatment: antibacterials (from 59% to 50%), systemic corticosteroids (55% to 29%), antihistamines (54% to 38%) and cyclosporine (52% to 7%). A similar trend was observed among patients with asthma as comorbidity. Within 12 months before/after dupilumab, patients hospitalized halved from 14% to 7%, and patients receiving outpatient specialist care reduced from 72% to 65%. Annual mean direct total costs per patient treated with dupilumab charged to the SSN, net of dupilumab cost, were €1384 and €773, before and after dupilumab dispensation, respectively.