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Lebrikizumab + topical corticosteroids demonstrated in a third phase III study ,significant skin improvement and itch relief in people with atopic dermatitis.

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Last updated:21st Dec 2021
Published:21st Dec 2021
Lebrikizumab, an IL-13 inhibitor, significantly improved disease severity when combined with topical corticosteroids (TCS) in people with moderate-to-severe atopic dermatitis (AD) in Eli Lilly and Company's third pivotal Phase III trial (ADhere).

By Week 16, the study met all primary and key secondary endpoints for patients on the lebrikizumab combination arm.

The primary endpoints were Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin with a reduction of at least two points from baseline and at least a 75 percent change from baseline in the Eczema Area and Severity Index (EASI) score, both at Week 16. Lebrikizumab in combination with TCS (topical corticosteroids) also achieved all key secondary endpoints versus placebo in combination with TCS in patients with AD, including skin improvement, itch relief, improvement in interference of itch on sleep, and quality of life.

Key secondary endpoints were measured by EASI, the Pruritus Numeric Rating Scale, Sleep-Loss due to Pruritus, and the Dermatology Life Quality Index. Safety results in the 16-week placebo-controlled ADhere study were consistent with the 16-week period of the two monotherapy studies in the lebrikizumab Phase III program for AD. The most common adverse events (AEs) included conjunctivitis and headache for lebrikizumab-treated patients.

In August 2021, Lilly announced top-line data from ADvocate 1 and ADvocate 2 showing lebrikizumab as a monotherapy met primary and all key secondary endpoints including itch, interference of itch on sleep and quality of life at Week 16.

Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and U.S. and global medical affairs at Lilly said "These results add to the growing body of evidence from our robust Phase III clinical trial program for lebrikizumab and support the hypothesis that targeting the IL-13 pathway is critical in treating AD and helping improve outcomes for these patients. We look forward to continuing to evaluate lebrikizumab's clinical utility in the ongoing studies in the hopes of making this medicine available to those who still have unmet needs."

Additional data analyses from ADhere, along with results from two monotherapy Phase III trials, ADvocate 1 and ADvocate 2, are planned for future scientific congresses in 2022. Pending successful completion of the ongoing ADvocate 1 and ADvocate 2 monotherapy trials, Lilly and Almirall intend to begin U.S., EU and other regulatory submissions next year.

Lilly has exclusive rights for development and commercialization of lebrikizumab in the United States and rest of world outside Europe. Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe.

About ADhere and the Phase III Program: ADhere is a 16-week randomized, double-blind, placebo-controlled, parallel-group, Phase III study to evaluate the efficacy and safety of lebrikizumab in combination with TCS in adult and adolescent patients (aged 12 to less than 18 years of age and weighing at least 40 kg) with moderate-to-severe AD. In the study, patients' AD symptoms were inadequately controlled by TCS with or without topical calcineurin inhibitors (TCI). The lebrikizumab Phase III program consists of five key ongoing, global studies including two monotherapy studies, today's ADhere combination study as well as long-term extension (ADjoin) and adolescent open label (ADore) trials.

Condition: Atopic Dermatitis (Eczema)
Type: drug

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