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Robust Pipeline for Atopic Dermatitis

Robust Pipeline for Atopic Dermatitis

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Until recently, atopic dermatitis treatments were limited primarily to topical corticosteroids and systemic immunosuppressants.

Now, however, two new therapies have reached clinical practice, and by one recent account there are at least 19 more topicals and biologics in development for atopic dermatitis.

“Our improved understanding about the mechanism for development of atopic dermatitis is leading to an expanding pipeline of new and more targeted treatment interventions,” Amy S. Paller, MD, chair of dermatology and director of the Northwestern University Skin Disease Research Center in Chicago, and colleagues wrote in a review in the Journal of Allergy and Clinical Immunology.

The emerging agents in atopic dermatitis include interleukin (IL)-4, IL-13, IgE, B-cells, IL-5, IL-31, JAK-STAT, SYK, IL-6, phosphodiesterase (PDE)-4, IL-12, IL-17, IL-23, IL-22, H4R, NKR1, κOR, TSLP, PPAR-γ, and diomogammalinolenic acid, the authors noted. In some cases, clinical trials have shown statistically significant improvements in clinical severity scores and patient-reported outcomes. In other cases, safety profiles are good, but many of these agents are in early trials.

Most Promising Atopic Dermatitis Treatments

Among the most promising new atopic dermatitis treatments are crisaborole (Eucrisa), from Pfizer, and dupilumab (Dupixent), from Regeneron, Paller et al noted. Crisaborole is a non-steroidal topical PDE-4 inhibitor approved by the FDA in 2016 for mild to moderate eczema (atopic dermatitis) in patients age 2 or older. Dupilumab is the first highly effective monoclonal antibody to be approved by the FDA. The agent targets IL-4/IL-13 and was approved early this year for adults with moderate-to-severe atopic dermatitis.

There are 12 other biologic agents under development, including nemolizumab, an anti-IL-31 receptor that specifically targets a cytokine that causes itch, which, if successful in clinical trials, would be the first biologic agent designed to control itch, the authors said.

There are six orally administered small-molecule inhibitors that have reached at least phase II trials, including baricitinib, an oral JAK1/2 inhibitor that is under study in the United States for rheumatoid arthritis. Researchers reporting at the European Academy of Dermatology and Venereology Congress earlier this year found that baricitinib improved atopic dermatitis symptoms in combination with a topical corticosteroid and serlopitant, the NK1R inhibitor being studied specifically for pruritus in atopic dermatitis.

These emerging therapies have the potential to revolutionize care, although there could be barriers to optimal clinical practice, including cost, Paller and colleagues wrote. “The extent of their effect on patient care will depend on their affordability and accessibility to patients with atopic dermatitis from a broad range of socioeconomic groups and with different insurance status.”

Long-term safety of target therapy is also an open question that requires further research, according to the authors of a review of novel therapeutic approaches to atopic dermatitis, published in August in Archivum Immunologiae et Therapiae Experimentalis.

And in another review, in the Journal of Dermatological Treatment, Vivian Shi, MD, and co-authors said that atopic dermatitis is entering a new era of target-specific treatments: “While these agents have demonstrated efficacy and potential, only dupilumab has been approved to date for adults with atopic dermatitis. Further large-scale, randomized, placebo-controlled, double-blind, multicenter trials are needed to fully evaluate the clinical benefit, safety, and cost effectiveness of these emerging therapies.”

A clear gap in the data right now is the role of novel atopic dermatitis treatments in children, which is especially important since atopic dermatitis is more prevalent in pediatric populations, the authors stated.

Further research in novel targeted atopic dermatitis therapies may be advanced by the development of the International Treatment of Atopic Eczema (TREAT) Registry Taskforce, which was started in 2017 and is designed to integrate data on systemic immunomodulatory therapies and phototherapy from dermatology communities around the world, Shi and colleagues wrote.

“The completion and continuous update of this task force will reduce heterogeneity among international clinical trial registries, allow direct comparison of data sets, and facilitate drug efficacy and safety monitoring.”

This article originally appeared on the website of our partner Dermatology Times, which is a part of UBM Medica. (Free registration is required.)

2017-11-26T11:00:00-0500

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