Eli Lilly and Company's Ebglyss met its primary and secondary endpoints in the Phase IIIb ADtouch study in adults and adolescents with moderate-to-severe hand and foot atopic dermatitis, supporting a US FDA submission for a potential label update covering the localized form of the disease.
Hand and foot AD can cause disproportionate disability despite affecting relatively little total body surface area, because itch, pain, fissuring, and inflammation can interfere with walking, work, and routine use of the hands. In the ADtouch trial, most patients had limited atopic dermatitis elsewhere on the body despite moderate-to-severe involvement of the hands and feet.
Lebrikizumab (Ebglyss) is an IgG4 monoclonal antibody that selectively blocks interleukin-13 (IL-13), a cytokine involved in type 2 inflammation and skin-barrier dysfunction in atopic dermatitis. Ebglyss is already FDA-approved for patients aged 12 years and older weighing at least 40 kg with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies.
ADtouch randomized 221 patients with moderate-to-severe hand and foot involvement and inadequate response to topical therapy to Ebglyss 250 mg every two weeks or placebo for 16 weeks. At Week 16, 53% of Ebglyss-treated patients achieved clear or almost-clear hands and feet with at least a 2-point improvement on the Hand and Foot Investigator Global Assessment, compared with 27% on placebo.
Meaningful itch improvement occurred in 57% versus 19% and pain improvement in 59% versus 19%, while 77% of Ebglyss-treated patients reported being satisfied or very satisfied with hand clearance compared with 40% on placebo. Significant differences emerged by Week 4 for skin clearance and as early as Week 2 for itch and pain.