礼来公司公布最新研究数据：Lebrikizumab可显著改善特应性皮炎患者的皮肤和瘙痒问题

Atopic dermatitis (AD) is a chronic, relapsing, inflammatory skin disease, mainly characterized by chronic eczematous rash, accompanied by obvious dry skin and itching. At present, there is no complete cure for this type of disease, but through standardized treatment, symptoms can be alleviated and recurrence can be reduced.

Lebrikizumab is a novel investigational monoclonal antibody (mAb) that binds to soluble IL-13 with high affinity, has high bioavailability, long half-life, and can block IL-13 signaling. In AD patients, overexpression of the IL-13 protein, a central pathogenic mediator of the disease, drives multiple aspects of AD pathophysiology by promoting type 2 helper T (Th2) cell inflammation, leading to skin barrier dysfunction, pruritus, infection, flares, and skin hardness and thickening.

The trial's primary endpoints were at least a 2-point decrease from baseline in the Investigator's Global Assessment (IGA) score of clear (0) or nearly clear (1) skin and at least a 75% change from baseline in the Eczema Area and Severity Index (EASI) score at week 16. In patients with AD, lebrikizumab plus TCS also met all key secondary endpoints, including skin improvement, relief of itch, improvement in sleep interference from itch, and improvement in quality of life compared with placebo plus TCS.

The safety profile of the 16-week placebo-controlled ADhere study was consistent with the safety profile of two monotherapy studies (16 weeks) of lebrikizumab in a Phase 3 program in patients with AD. The most common adverse events in patients treated with lebrikizumab included conjunctivitis and headache.

In August 2021, Eli Lilly announced top-level data from the ADvocate 1 trial and ADvocate 2 trial. The results showed that Lebrikizumab, as a monotherapy, achieved its primary endpoint and all key secondary endpoints at week 16, including pruritus, itch interference with sleep and quality of life.

Additional data analysis from the ADhere study, as well as results from the Phase 3 ADvocate 1 and ADvocate 2 trials, are planned to be presented at the Future Science Conference in 2022. Pending successful completion of the ongoing ADvocate 1 trial and ADvocate 2 trial, Eli Lilly and Almirall plan to begin submissions to U.S., EU and other regulatory agencies in 2022.

Dr. Karl Ziegelbauer, chief scientific officer of Almirall, said: "These results verify the important role of IL-13 cytokine inhibitors in the treatment of AD. The positive results brought by Lebrikizumab promote the development of the field of AD treatment and bring new hope to AD patients."

Eli Lilly has exclusive development and commercialization rights to lebrikizumab in the United States and other territories outside of Europe. Almirall also acquired the rights to develop and commercialize lebrikizumab in Europe for the treatment of skin disease indications including AD. We hope Lebrikizumab will get good results soon and benefit more patients.

References:

https://investor.lilly.com/news-releases/news-release-details/lillys-lebrikizumab-demonstrated-significant-skin-improvement