Eli Lilly and Company’s (NYSE:LLY) Phase 3 monotherapy ADvocate trials in atopic dermatitis (AD) found that the investigational interleukin 13 inhibitor lebrikizumab supported durable skin clearance and reduced itching in a subset of patients with atopic dermatitis.
The Indianapolis–based company defined responders as those with at least 75% improvement in the Eczema Area and Severity Index from baseline (EASI-75) or an Investigator Global Assessment of 0 or 1 (“clear” or “almost clear”) with a 2-point improvement at week 16 without rescue medication. The clinical trial re-randomized responders to receive lebrikizumab 250 mg every two weeks or four weeks or a placebo for 36 more weeks.
Lebrikizumab performed similarly in responders when dosed at a two- or four-week interval after week 16.
“Despite available treatment options, many patients with atopic dermatitis experience distressing symptoms every day over the course of years. Thus, there is a clear need for new therapies that maintain long-term results,” said Dr. Andrew Blauvelt, lead author of the ADvocate analyses, in a news release.
Blauvelt said that the data from the ADvocate studies “help deepen our understanding of the role lebrikizumab may play in treating atopic dermatitis and will assist practitioners to improve clinical outcomes for their patients with this chronic disease.”
After a 16-week induction period, lebrikizumab efficacy was similar regardless of whether it was dosed with a two- or four-week dosing interval.
A total of 58% of participants in the ADvocate 1 study reported adverse events, while 68% did in the ADvocate 2 trial. Most of those adverse events were mild or moderate and did not lead participants to discontinue therapy. The most common reported adverse events were conjunctivitis, common cold and headache.
Lilly notes that the lebrikizumab’s safety profile in the two trials was in line with expectations.
LLY shares were up 1.25%, hitting $315.50.
Filed Under: clinical trials, Dermatology, Drug Discovery