Washington, D.C.—Treatment for moderate-to-severe dermatitis was effective for adults and adolescents who received lebrikizumab over 16 weeks, according to a new study.

An article in the New England Journal of Medicine reported on the two phase III trials of lebrikizumab, a novel humanized monoclonal antibody that selectively inhibits interleukin-13 (IL-13), specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling. IL-13 is thought to be a factor in atopic dermatitis.

“These are the largest studies of lebrikizumab in atopic dermatitis to date,” Jonathan I. Silverberg, MD,  the coinvestigator of the study and associate professor of dermatology at George Washington (GW) University School of Medicine & Health Sciences, added. “Our results showed lebrikizumab to be safe, highly-effective and well tolerated in patients with moderate to severe atopic dermatitis.”

A press release from GW noted that atopic dermatitis affects 20% of children and up to 7% of adults worldwide.

In the first trial, 283 patients were randomly assigned to the active drug group and 141 patients to the placebo group. In the second trial, 281 patients received lebrikizumab and 146 patients were in the placebo group.

After 16 weeks, researchers determined that lebrikizumab therapy led to improvements, compared with a placebo, in study outcomes. Those included markers such as significantly clearer skin, reduced itching, and improved sleep. Study authors added that, while 16 weeks is adequate to assess long-term safety, only mild or moderate side effects with a low incidence occurred in this study.

The central role of I-13 in the pathogenesis of the disease also appeared to be confirmed; researchers have posited that lebrikizumab binds with interleukin-13 and, therefore, leads to improvements in dermatitis.

The FDA granted Fast Track designation to lebrikizumab (Dermira, Inc) in 2019 for the treatment of moderate-to-severe atopic dermatitis.

“Lebrikizumab therapy led to improvements, as compared with placebo, with regard to the primary outcome and all the secondary outcomes at week 16, significantly improving skin clearance (as measured by the IGA and EASI [Eczema Area and Severity Index score]), itch (as measured by the Pruritus NRS [numerical rating scale]), and interference of itch with sleep (as measured by the Sleep-Loss Scale),” according to researchers in the recent study. “The benefits of lebrikizumab therapy were observed with respect to all the secondary outcomes at week 2 and week 4, except for the Pruritus NRS score at week 2 in trial 2. These results show a rapid onset of action in multiple domains of the disease, such as skin clearance and itch. These results confirm the findings from the phase 2 trials of lebrikizumab.”

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