Lebrikizumab Combined with Topical Corticosteroids Showed Significant Improvements in Disease Severity for Atopic Dermatitis

At 16 weeks, 70 percent of patients with moderate-to-severe atopic dermatitis (AD) receiving lebrikizumab combined with standard-of-care topical corticosteroids (TCS) achieved at least 75 percent improvement in overall disease severity (EASI-75^*) in the ADhere trial, as announced today by Almirall S.A. (BME: ALM) and presented at the 4^th Annual Revolutionizing Atopic Dermatitis (RAD) Conference. Lebrikizumab, an investigational IL-13 inhibitor, also showed improvements in itch, sleep interference, and quality of life when combined with TCS compared to placebo plus TCS.

“Dermatologists and patients with atopic dermatitis call for effective treatment options that achieve skin clearance and control the debilitating symptoms of the disease, such as itch, as well as improving quality of life,” stated Dr. med. Andreas Pinter, Director of Clinical Research at the University Hospital in Frankfurt/Main (Germany) and one of the investigators of the ADhere trial. “Data from ADhere, one of the five global studies in the lebrikizumab Phase 3 program, together with the exciting data reported in March from the two monotherapy studies ADvocate 1 and ADvocate 2, reinforce the potential of this new treatment to become a valuable treatment for patients with atopic dermatitis.”

Lebrikizumab is a novel, monoclonal antibody (mAb) that binds to the interleukin 13 (IL-13) protein with high affinity to specifically prevent the formation of IL-13Rα1/IL-4Rα (Type 2 receptor) which blocks downstream signaling through the IL-13 pathway.^1-5 IL-13 plays the central role in Type 2 inflammation in AD.^6,7 In AD, IL-13 underlies the signs and symptoms including skin barrier dysfunction, itch, infection and hard, thickened areas of skin.⁸

At 16 weeks, 70 percent of patients taking lebrikizumab plus TCS achieved an EASI-75 response compared to 42 percent taking placebo plus TCS. Among patients taking lebrikizumab plus TCS, 41 percent achieved clear or almost clear skin (IGA) at 16 weeks compared to 22 percent of patients taking placebo plus TCS. Differences between patients receiving lebrikizumab in combination with TCS and placebo with TCS were observed as early as four weeks for EASI-75.

Patients treated with lebrikizumab plus TCS also achieved statistically significant improvements across key secondary endpoints including skin clearance and itching, interference of itch on sleep, and quality of life measures, compared to placebo with TCS. Clinically meaningful differences were observed as early as four weeks for itch, interference of itch on sleep, and quality of life measures.

Safety results were consistent with prior lebrikizumab studies in AD. Patients taking lebrikizumab plus TCS, compared to placebo plus TCS, reported a higher frequency of adverse events (lebrikizumab plus TCS: 43%; placebo plus TCS: 35%). Most adverse events were mild or moderate in severity and nonserious and did not lead to treatment discontinuation. The most common adverse events for those on lebrikizumab were conjunctivitis (5%) and headache (5%).

“We are pleased to announce the latest data from the lebrikizumab study combined with topical corticosteroids that support its potential in atopic dermatitis. These data suggest that lebrikizumab can be combined with topical corticosteroid treatment, and are a further step in our commitment to deliver innovative therapies that make a meaningful difference to patients. We look forward to continuing to announce exciting new milestones leading up to potential approval in the EU,” commented Karl Ziegelbauer, Ph.D., Almirall S.A.’s Chief Scientific Officer.

Almirall recently announced 16-week data from the ongoing ADvocate studies, and an encore presentation of results was presented at RAD 2022. Additionally, longer term data from the ADvocate studies will be disclosed in coming months.

“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, M.D., Ph.D., vice president of global immunology development and medical affairs at Eli Lilly and Company.

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

*EASI=Eczema Area and Severity Index, EASI-75=75 percent reduction in EASI from baseline to Week 16