A report published by Silverberg et al in The New England Journal of Medicine outlined the results of two phase III trials evaluating the efficacy of lebrikizumab—a high-affinity IgG4 monoclonal antibody targeting interleukin-13—for adolescents and adults with moderate to severe atopic dermatitis. The two trials—identically designed and called ADvocate1 and ADvocate2—together enrolled over 800 patients, including adults aged 18 or over and adolescents aged 12 to under 18. Patients were randomly assigned 2:1 to receive lebrikizumab or a placebo; the primary endpoint was an Investigator’s Global Assessment (IGA) score of 0 or 1 (signifying clear or nearly clear skin), with a reduction of at least 2 points from baseline at week 16.
In ADvocate1, approximately 43% of patients treated with lebrikizumab reached the primary endpoint, and in ADvocate2, about 33% of patients did; itch and itch interference with sleep were improved with the agent as well. The results of these phase III trials confirmed the results of earlier phase II trials conducted with lebrikizumab.