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New phase 3 data found that 70% of patients with atopic dermatitis achieved EASI-75 following treatment with lebrikizumab and topical corticosteroids
New 16-week data on lebrikizumab found that 70% of patients with moderate to severe atopic dermatitis who received the biologic along with topical corticosteroids (TCS) achieved at least 75% improvement in overall disease severity (EASI-75) compared to 42% of patients taking placebo plus TCS.
Treatment with the IL-13 inhibitor and TCS also led to clinically meaningful differences for itch, interference of itch on sleep, and quality of life measures as early as 4 weeks.
The ADhere trial findings were presented at the 4th Annual Revolutionizing Atopic Dermatitis (RAD) Conference.
The trial was a 16-week, double-blind, placebo-controlled, global, phase 3 study that evaluated the safety and efficacy of lebrikizumab in combination with TCS in adult and adolescents 12-18 years weighing at least 40 kg with moderate to severe atopic dermatitis. It is 1 of 5 global trials related to the efficacy of lebrikizumab.
All eligible patients had disease symptoms that were inadequately controlled by TCS with or without topical calcineurin inhibitors (TCI).
In addition to the encouraging EASI-75 responses, 41% of patients treated with lebrikizumab and TCS achieved clear or almost clear skin (IGA) at 16 weeks compared to 22% of patients in the placebo group.
Safety results were also consistent with prior lebikizumab studies in patients with atopic dermatitis.
Compared to the placebo group, patients taking lebrikizumab plus TCS reported a higher frequency of adverse events including conjunctivitis (5%) and headache (5%). However, most adverse events were mild or moderate in severity did not lead to treatment discontinuation.
Longer-term data on lebrikizumab from the ADvocate studies will be presented in the coming months, according to a press release from Almirall.
“We look forward to seeing the full results from our broader Phase 3 program and continuing to advance lebrikizumab for people with atopic dermatitis worldwide,” said Lotus Mallbris, MD, PhD, vice president of global immunology development and medical affairs at Eli Lilly and Company.