Emerging drugs for the treatment of atopic dermatitis: a focus on phase 2 and phase 3 trials

ABSTRACT

Introduction

Atopic dermatitis (AD) is an inflammatory skin condition that affects millions of pediatric and adult patients with well-studied impact on morbidity and quality of life. Management occurs in a stepwise fashion beginning with preventative measures before immunomodulators are introduced. However, challenges remain in treatment of moderate-to-severe atopic dermatitis that is refractory to first- and second-line treatments and there are only few topical anti-inflammatory options, especially for pediatric patients.

Areas covered

New medications are required to address these gaps as lesions may persist despite treatment or patients may discontinue treatment due to actual or anticipated adverse effects of mainstay medications. Emerging research into the pathophysiology of AD and the immune system at large has provided opportunities for novel interventions aimed at stopping AD mechanisms at new checkpoints. Clinical trials for 36 agents currently in phase 2 or phase 3 are evaluated with particular focus on the studies for, B244, CBP-201, tapinarof, lebrikizumab, nemolizumab, amlitelimab, and rocatinlimab as they explore novel pathways and have some of the most promising results.

Expert opinion

These clinical trials contribute to the evolution of AD treatment toward greater precision based on salient pathways with a particular focus on moderate-to-severe AD to enhance efficacy and minimize adverse effects.

KEYWORDS:

• Atopic dermatitis
• tapinarof
• lebrikizumab
• nemolizumab
• JAK inhibitor
• amlitelimab
• rocatinlimab
• OX40

Article highlights

• Even as the range of therapies for AD continues to expand, control over moderate-to-severe disease remains challenging for some patients. In addition, treatment options for young children are limited.

• New agents in the pipeline target disease mechanisms based on our understandings of the immune response in AD.

• There is heightened focus on safety, reducing adverse effects, and addressing factors that limit adherence to treatment.

Declaration of interests

P. Ong reports advisory board for Incyte, AbbVie, Janssen, Dermavant, and research funding from Regeneron, Sanofi Genzyme, Leo and Incyte. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.