In Phase 3 research, lebrikizumab combined with topical corticosteroids resulted in significant skin improvement and itch reduction in persons with atopic dermatitis

0 38

In Eli Lilly and Company’s third pivotal Phase 3 trial, lebrikizumab, an IL-13 inhibitor, significantly improved disease severity when coupled with topical corticosteroids in persons with moderate-to-severe atopic dermatitis . Patients on the lebrikizumab combo arm had met all primary and key secondary objectives by Week sixteen.

Lebrikizumab is an experimental monoclonal antibody (mAb) that binds soluble IL-13 with high affinity, has a high bioavailability, and a long half-life, as well as blocking IL-13 signalling. 1-5 The IL-13 protein is overexpressed in persons with Alzheimer’s disease, driving several facets of disease pathophysiology by boosting T-helper type 2 (Th2) cell inflammation, resulting in skin barrier dysfunction, itch, infection, flares, and hard, thickened regions of skin.

“AD is often complex and challenging to treat, as many patients need help controlling their symptoms when topical steroids alone are not enough. I’m encouraged by the aggregate efficacy and safety data which have demonstrated the potential for lebrikizumab as both monotherapy and combination therapy to address unmet needs and improve care for people living with persistent itch and inflamed skin caused by AD,”

said Eric Simpson, M.D., M.C.R., Professor of Dermatology and Director of Clinical Research at Oregon Health & Science University in Portland and a principal investigator of the ADhere study.

At Week 16, the primary outcomes were an Investigator Global Assessment (IGA) score of clear or almost clear skin with a reduction of at least two points from baseline and an Eczema Area and Severity Index (EASI) score of at least a 75 percent change from baseline. In patients with Alzheimer’s disease, lebrikizumab in conjunction with TCS met all of the secondary objectives compared to placebo in combination with TCS, including skin improvement, itch relief, itch interference with sleep, and quality of life. EASI, the Pruritus Numeric Rating Scale, Sleep-Loss due to Pruritus, and the Dermatology Life Quality Index were used to assess key secondary objectives.

The 16-week placebo-controlled ADhere research found that the safety outcomes were comparable to the 16-week timeframe of the two monotherapy studies in the lebrikizumab Phase 3 programme for AD. For lebrikizumab-treated patients, the most common adverse events (AEs) were conjunctivitis and headache.

Lilly reported top-line data from ADvocate 1 and ADvocate 2 in August 2021, revealing that lebrikizumab as a monotherapy met primary and all critical secondary objectives at Week 16, including itch, itch interference with sleep, and quality of life.

“Physicians treating atopic dermatitis continue to need new options for their patients along with current standard of care, given the heterogeneity of disease and variable outcomes for patients’ signs and symptoms. These results add to the growing body of evidence from our robust Phase 3 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,”

said Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and U.S. and global medical affairs at Lilly. 

Future scientific congresses in 2022 will provide additional data analyses from ADhere, as well as results from two monotherapy Phase 3 trials, ADvocate 1 and ADvocate 2. Lilly and Almirall plan to commence U.S., EU, and foreign regulatory submissions next year, pending the successful completion of the ongoing ADvocate 1 and ADvocate 2 monotherapy trials.

“These results validate the important role that IL-13 cytokine inhibitors play in AD treatment and the success of lebrikizumab in this study represents another key achievement in our journey to offer treatment advances in AD for patients and healthcare professionals,”

stated Karl Ziegelbauer, Ph.D., Almirall S.A.’s Chief Scientific Officer.

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

Leave A Reply

Your email address will not be published.