REVIEW   Free access

Giornale Italiano di Dermatologia e Venereologia 2019 December;154(6):696-713

DOI: 10.23736/S0392-0488.19.06417-4

Copyright © 2019 EDIZIONI MINERVA MEDICA

language: English

Dupilumab for atopic dermatitis: evidence to date

Maria A. RODRIGUES ¹, Miguel NOGUEIRA ¹, Tiago TORRES ^{1, 2} ✉

¹ Service of Dermatology, University Hospital of Porto, Porto, Portugal; ² Abel Salazar Institute of Biomedica Sciences, University of Porto, Porto, Portugal

INTRODUCTION: Atopic dermatitis (AD) is a common chronic, pruritic inflammatory dermatosis. The inflammatory response is characterized by a T helper 2 (Th2) immune response phenotype.
EVIDENCE ACQUISITION: To assess current available data on dupilumab, the writers of this article did a comprehensive search in different databases, including Medline, EMBASE, SCOPUS, and clinical trial registries. All relevant articles identified were then manually reviewed. Information regarding dupilumab mechanism of action, pharmacokinetics, clinical efficacy, safety, and future trends was then summarized.
EVIDENCE SYNTHESIS: Topical therapy is the main treatment in mild-to-moderate AD, but many cases of moderate-to-severe require systemic treatments. Dupilumab is the first biologic approved for the treatment of adults with moderate-to-severe AD. It inhibits IL-4 and IL-13 signaling pathways and reduces Th2 response. Clinical trials have demonstrated significantly improved clinical and patient-reported outcomes. The addition of application of topical corticosteroids results in a more significant improvement in signs and symptoms of AD than with use of dupilumab in monotherapy. The vast majority of patients improves under dupilumab, and almost 40% of patients achieve clear or nearly clear skin. In addition to its effectiveness, dupilumab also has a favorable safety profile. Frequent adverse events reported in the clinical trials were mostly mild-to-moderate and included nasopharyngitis, upper respiratory tract infection, injection site reactions, and conjunctivitis.
CONCLUSIONS: In general, rates of adverse events occurred with similar frequency between the treatment and placebo groups. Conjunctivitis seems to be a dupilumab-specific side effect and so far has only been observed in atopic dermatitis patients (not in asthma or nasal polyposis). There were no major serious safety concerns identified in phase III clinical trials. Trials in the pediatric population are ongoing and are highly awaited.

KEY WORDS: Biological products; Dupilumab; Dermatitis, atopic; Enzyme therapy; Interleukin-4; Interleukin-13