Innovative Immunotherapy for the Treatment of Atopic Dermatitis: Focus on the European and Latin American Regulatory Frameworks

This review focused on the mechanisms of action, safety profiles, and efficacy of new and promising systemic immunological treatments for AD. In particular, it has been highlighted how new treatments’ targets participate in the pathogenic mechanisms of AD. The introduction of new pharmacological agents can provide new therapeutic options, but there is the need to evaluate how “narrow-acting” agents like individual interleukin inhibitors will perform under the safety and efficacy profiles compared with “broad-acting” agents like JAK inhibitors. Furthermore, the article aimed to describe and compare the marketing of these medicines in the European and Latin American markets, comparing the access requirements to these innovative treatments for patients affected from atopic dermatitis in both regions.

Moderate to severe AD is often refractory to first-line topical treatments, while systemic immunosuppressants have shown efficacy but have significant side effects. The limited availability of basic treatments has led to the development of targeted topical and systemic immunotherapies, including small molecule drugs and biologics, representing a new era of therapeutic innovation. In 2016, the US Food and Drug Administration (FDA) approved a topical phosphodiesterase-4 inhibitor (PDE4i), crisaborole, and in 2017, a monoclonal antibody, dupilumab.

Atopic dermatitis (AD) is a common inflammatory skin disease characterized by itching and skin barrier dysfunction. Moderate to severe AD is often refractory to first-line topical treatments, and systemic immunosuppressants have been shown to be effective but have significant adverse effects. The paucity of basic treatments has contributed to the development of targeted topical and systemic immunotherapies based on the use of small molecules and biologic drugs which can directly interact with AD pathogenetic pathways. They represent a new era of therapeutic innovation. Additional new treatments are desirable since AD is a heterogeneous disease marked by different immunological phenotypes. This manuscript will review the mechanism of action, safety profile, and efficacy of promising new systemic immunological treatments for AD which are placed on the European and Latin American markets, making a comparison between the two current regulatory frameworks. Since moderate to severe AD can result in poor quality of life, the development of targeted and well-tolerated immunomodulators is a crucial purpose in both regions. The introduction of new pharmacological agents may offer new therapeutic options.