Real-life experience on effectiveness and safety of dupilumab in adult patients with moderate-to-severe atopic dermatitis

J Dermatolog Treat. 2021 Aug;32(5):507-513. doi: 10.1080/09546634.2019.1682503. Epub 2019 Oct 28.


Background: Dupilumab, a fully human monoclonal antibody targeting the alpha subunit of IL-4 was recently approved for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients.

Objective: To assess dupilumab effectiveness and safety in adults with moderate-to-severe AD in a real-life Italian multicentre retrospective cohort.

Methods: Adult moderate-to-severe AD patients, referring to 39 Italian centers, received dupilumab in the context of a national patient access program. Disease assessment was performed at baseline, after 4 and 16 weeks of treatment using Eczema-Area-and-Severity-Index (EASI) score, itch and sleep numerical-rating-score (itch-NRS, sleep-NRS) and Dermatology-Life-Quality-Index (DLQI).

Results: A total of 109 (71 M/38F) patients was studied. There was a significant reduction in EASI score, itch-NRS, sleep-NRS and DLQI from baseline to week 4 and a further significant decline to week 16. EASI 50, EASI75 and EASI90 were achieved by 59.6%, 28.4% and 9.3% of patients at 4 weeks and by 87.2%, 60.6% and 32.4% of them at 16 weeks, respectively. Adverse events were experienced by 19.2% (21/109) of the patients and they were all mild in intensity, being conjunctivitis the most common side effect.

Conclusions: Dupilumab significantly improved disease severity, pruritus, sleep loss and quality of life with an acceptable safety profile.

Keywords: Atopic dermatitis; dupilumab; real-life.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Cohort Studies
  • Dermatitis, Atopic / drug therapy*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pruritus* / drug therapy
  • Quality of Life*
  • Retrospective Studies
  • Severity of Illness Index
  • Sleep
  • Treatment Outcome
  • Young Adult


  • Antibodies, Monoclonal, Humanized
  • dupilumab