Lebrikizumab effective against moderate to severe atopic dermatitis, trials find

Key takeaways:

• The whole monoclonal antibody lebrikizumab was effective in a pair of trials against atopic dermatitis in children and adults.
• The goal is FDA approval by the end of 2023.

Two phase 3 trials found that lebrikizumab was effective against moderate to severe atopic dermatitis in adolescents and adults, researchers reported in The New England Journal of Medicine.

“Lebrikizumab is a whole monoclonal antibody that targets interleukin-13, which has been shown to be important in the pathogenesis of atopic dermatitis,” Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research and an associate professor of dermatology at the George Washington University School of Medicine and Health Sciences, told Healio.

Silverberg and colleagues conducted a pair of randomized, double-blind, placebo-controlled phase 3 trials of lebrikizumab administered subcutaneously every 2 weeks to adolescents aged 12 to 17 years and adults aged 18 year or older with moderate-to-severe atopic dermatitis.

Both trials included a 16-week induction period and a 36-week maintenance period. The results reported in the journal included outcomes only for the 16-week induction period.

The researchers randomly assigned participants in a 2:1 ratio to receive a 250 mg dose of either lebrikizumab or a placebo, administered under the skin every 2 weeks throughout the induction period, with a loading dose of 500 mg given at baseline and week 2.

Silverberg and colleagues measured outcomes using an Investigator’s Global Assessment score ranging from 0 to 4. The primary outcome was a score of 0 or 1 — which indicates “clear or almost clear skin,” they wrote — with a score reduction of at least 2 points from baseline at week 16, which they noted would indicate an improvement.

In the first trial, 43.1% of 283 subjects in the lebrikizumab group met the primary outcome compared with 12.7% of 141 patients in the control group, the researchers reported. In the second trial, 33.2% of 281 patients in the lebrikizumab group met the primary outcome vs. 10.8% of 146 patients in the control group.

“There were many, many outcome measures that were assessed, and it almost didn't matter. All of them showed great improvement with lebrikizumab treatment,” Silverberg said. “We were certainly very optimistic already based on the last few studies, and quite fortunately, the results have delivered, I think, as well or even better than anyone expected.”

“When we see this kind of reproducible high level of efficacy with a collective interleukin-13 blocker, and compare that with other therapies that are out there, it indicates that this mechanism, indeed, is highly effective and is sufficient, essentially to achieve good results,” Silverberg said.

He said they are “optimistic” that lebrikizumab will be authorized by the end of the year.

“Our hope is that the FDA will approve lebrikizumab before the end of 2023,” Silverberg said.