Lebrikizumab dosed every four weeks maintained durable skin clearance in phase III monotherapy atopic dermatitis trials

Lebrikizumab, a high-affinity and potent IL-13 inhibitor, delivered similar results when dosed once every four weeks or once every two weeks after Week 16. These data were featured in a late-breaking, oral presentation at the 31st European Academy of Dermatology and Venerology (EADV) Congress.

The company previously announced topline results of these one-year analyses of ADvocate 1 and ADvocate 2 in June 2022.

"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 Andrew Blauvelt, M.D., board-certified dermatologist, president of Oregon Medical Research Center and lead author of the ADvocate analyses. "Lebrikizumab helped patients reduce the impact of atopic dermatitis by maintaining long-lasting skin clearance and itch relief with dosing at every four weeks in the ADvocate studies. These data 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."

Efficacy with every four week dosing, after a 16-week induction period with lebrikizumab every two weeks, was similar to that of every two week dosing. Safety among patients at 52 weeks was consistent with the induction phase of the trials and prior lebrikizumab studies in AD. The incidence rate of treatment-emergent adverse events remained stable over time in patients with lebrikizumab. The proportion of lebrikizumab-treated patients who reported an adverse event in ADvocate 1 and ADvocate 2 through Week 52 was 58% and 68%, respectively. Most adverse events across the two studies were mild or moderate in severity, non-serious and did not lead to treatment discontinuation. The most commonly reported adverse events were conjunctivitis, common cold and headache.

Full results from the Phase III studies will be published in a peer-reviewed journal. Lilly and Almirall S.A. plan to submit regulatory applications to FDA and European Medicines Agency (EMA) respectively for lebrikizumab in AD this year. The FDA granted lebrikizumab Fast Track designation in AD in December 2019.