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Crisaborole Ointment: a Novel, Nonsteroidal Atopic Dermatitis Treatment for Children and Adults

In the past 15 years, no new topical AD treatments have been approved. Crisaborole, however, could be an efficient, safe, non-steoidal treatment option, according to the results of two recent phase III studies.

Crisaborole could be an efficient and safe treatment option for atopic dermatitis (AD), according to the results of two recent phase III studies. Published in the Journal of the American Academy of Dermatology, the studies were conducted Amy Paller, MS, MD, of Northwestern University, Feinberg School of Medicine, in Chicago, Illinois, and colleagues.

The authors state their objective, saying “We sought to assess the efficacy and safety of crisaborole ointment, a phosphodiesterase 4 inhibitor, in two phase III AD studies.” In the past 15 years, no new topical AD treatments have been approved. The two most commonly used treatments, topical corticosteroids (TCS) and topical calcineurin inhibitors (TCI) have some limitations, leading the authors to say that “novel topical therapies that may potentially improve upon the risk-benefit profile of current therapies are needed.”

“Phosphodiesterase 4 (PDE4) is a key regulator of inflammatory cytokine production in AD through the degradation of cyclic adenosine monophosphate,” say the researchers. An oral form of PDE4 has been approved to treat psoriasis, but the researchers say, “A topical PDE4 inhibitor formulation could address the need for targeted inhibition of inflammation in skin diseases while avoiding unwanted side effects.”

The two studies were designed identically, and both included multiple centers, were randomized, double-blinded, vehicle controlled, and conducted in the US. Patients were randomized 2:1 to either receive crisaborole or vehicle treatment, and were instructed “to apply a layer of study drug to cover each lesion twice daily throughout the 28-day study,” say the researchers.

The Investigator’s Static Global Assessment (ISGA) score was used to determine the primary endpoint on day 29. The researchers described it with, “clear (0) / almost clear (1) with 2-grade or greater improvement from baseline. Additional analyses included time to success in ISGA score, percentage of patients achieving clear/almost clear, reduction in severity of AD signs, and time to improvement in pruritus.”

In both studies, “more crisaborole-treated patients achieved success in ISGA score at day 29 than vehicle-treated patients,” report the researchers. Additionally, those in the crisaborole-treated groups reached successful ISGA scores faster. Treatment-emergent adverse events (TEAEs) were mild to moderate, and relatively rare. “Application site pain was the only treatment-related AE that occurred in 1% or more of patients,” say the researchers.

In conclusions, the authors say that “Crisaborole represents a promising new option for patients with mild to moderate AD based on the favorable safety profile and improvement in AD seen in these studies.”