Lilly and Dermira’s Lebrikizumab improves itch, sleep and quality of life in patients with moderate-to-severe atopic dermatitis (AD), according to a Phase 2b clinical trial presented during a virtual late-breaking, oral session at the American Academy of Dermatology (AAD) 2020 Annual Meeting.
“Understanding the potential for lebrikizumab to improve the skin symptoms of atopic dermatitis as well as other commonly associated symptoms, such as itch and loss of sleep, is critical to understanding its true potential to help patients,” says lead author Emma Guttman-Yassky, M.D., Ph.D., the Sol and Clara Kest professor of dermatology, vice chair of the department of dermatology, director of the Center for Excellence in Eczema and director of the laboratory of inflammatory skin diseases in the department of dermatology at Icahn School of Medicine at Mount Sinai, in a news release. “These results suggest that lebrikizumab could provide clinically meaningful improvement in treating symptoms that are most bothersome to patients.”
The results of the data analysis showed that lebrikizumab improved symptoms and quality of life in a rapid, dose-dependent manner across a range of atopic dermatitis-specific and other measures compared with placebo. Specifically, lebrikizumab improved:
• Itch by Day 2 with further improvement to Week 16
• Sleep by the first on-treatment assessment at Week 1 with further improvement to Week 16
• Disease severity as assessed by the POEM (Patient-Oriented Eczema Measure) by the first on-treatment assessment at Week 16
• Dermatology health-related quality of life (DLQI) scores by the first on-treatment assessment at Week 8
• Patient global assessment of change at Week 16, with statistically significant improvements in patients treated with 250 mg Q4W or 250 mg Q2W of lebrikizumab, respectively, rating their atopic dermatitis as “1, much better” compared with patients treated with placebo.
“These data help us understand how the treatment may work for patients to alleviate symptoms such as itch and sleep which are known to severely impact the lives of the millions of patients living with atopic dermatitis,” adds Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. “We are currently evaluating lebrikizumab in a broad Phase 3 clinical program and look forward to further progressing this important investigational medicine given the clear need for additional options for patients living with this debilitating condition.”
“Itch is a debilitating symptom for people living with atopic dermatitis, and it affects the physical, mental, emotional, social and financial areas in their lives,” says Lisa Butler, senior vice president, strategic partnerships and programs at the National Eczema Association. “The burden on patients and families is still widely underappreciated, so it is encouraging to see new therapies in development that could potentially address the symptoms that this community struggles with the most on a daily basis.”
In the randomized, double-blind, placebo-controlled, Phase 2b dose-ranging study, 280 patients with moderate-to-severe atopic dermatitis were randomized 3:3:3:2 to one of three doses of subcutaneous lebrikizumab (125 mg every four weeks, 250 mg every four weeks, or 250 mg every two weeks) or placebo every two weeks for 16 weeks with safety follow-up to Week 32. The primary endpoint was the percent change in Eczema Area Severity Index (EASI) from baseline at Week 16. Secondary endpoints measured atopic dermatitis severity, itch, sleep loss, and included the proportions of patients achieving EASI50, EASI75, EASI90, a score of 0 or 1 on the Investigator’s Global Assessment (IGA), and a >4-point improvement on the pruritus (itch) 11-point numeric rating scale (NRS) assessing daily itch. Change in sleep loss from baseline also was measured.
Lebrikizumab was generally well-tolerated. The safety profile was consistent with previous studies, including low frequency of conjunctivitis, herpes virus infections and injection site reactions, the study showed.