18 May Lilly: Novel Monoclonal Antibody Shows Promise in Hard to Treat Facial and Hand Atopic Dermatitis
MedicalResearch.com Interview with:
Lotus Mallbris, MD PhD
Dermatologist andSenior Vice President
Global Immunology Development and Medical Affairs
MedicalResearch.com: What is the background for this study? Would you briefly describe what is meant by atopic dermatitis and types treated in this study?
Response: First, this study specifically evaluated lebrikizumab, a novel, investigational, monoclonal antibody that selectively binds to interleukin 13 (IL-13) with high-affinity and high potency. Inflammation due to over-activation of the IL-13 pathway plays a central role in the pathogenesis of moderate-to-severe atopic dermatitis, commonly called eczema.
This secondary analysis focused on patients treated with lebrikizumab from the 16-week induction periods of the ADvocate 1 and ADvocate 2 studies and the ADhere study. In the trials, we assessed the presence or absence of face or hand dermatitis in patients with moderate-to-severe atopic dermatitis. If present at baseline, at 16 weeks, clinicians assessed the change from baseline on a scale of cleared, improved, no change, or worsened. Only patients with face and hand dermatitis were evaluated as part of the analysis.
MedicalResearch.com: What are the main findings?
Response: These post-hoc data show 58-73% of adult and adolescent patients with hand or face dermatitis at baseline who received lebrikizumab and who were assessed at 16 weeks experienced improved or cleared skin. These results were seen with and without the use of topical corticosteroids.
MedicalResearch.com: How does lebrikizumab differ from other types of treatments for atopic dermatitis?
MedicalResearch.com: Lebrikizumab is a novel, investigational, monoclonal antibody designed to bind to IL-13 and works by targeting the type 2 inflammation that underlies the disease, rather than broadly suppressing the immune system. Specifically, it inhibits the signaling of the IL-13 protein, which plays a central role in the type 2 inflammation that is associated with atopic dermatitis. We are thrilled with the results from the Phase 3 clinical development program for lebrikizumab as a whole and remain confident in lebrikizumab’s competitive profile, if approved
MedicalResearch.com: What should readers take away from your report?
Response: Lebrikizumab has shown that it can provide robust improvements in the signs and symptoms of moderate-to-severe atopic dermatitis in adolescent and adult patients across three Phase 3 clinical trials (ADvocate 1, ADvocate 2, and ADhere). However, little is known about the response of lebrikizumab in difficult-to-treat regions such as the face and hands.
These are the first published data for lebrikizumab demonstrating improvements or clearance in the face and hand dermatitis, which can be particularly burdensome and stigmatizing because these areas are highly visible parts of the body. Results from this type of research are important to help inform dermatologists about treatments that may provide new options for their patients.
MedicalResearch.com: What recommendations do you have for future research as a results of this study?
Response: Despite existing treatment options for atopic dermatitis, there are still many people living with moderate-to-severe cases who are looking for an option to decrease the impact of this difficult-to-treat disease. These positive data add to the robust body of evidence on lebrikizumab. I’m interested in future research exploring underserved patients, like those with skin of color, or other difficult-to-treat patients like biologic-experienced. We are currently studying lebrikizumab in both populations.
MedicalResearch.com: Is there anything else you would like to add?
Response: Regulatory decisions for lebrikizumab as a potential treatment for adult and adolescent patients with moderate-to-severe atopic dermatitis in the U.S. and European Union are expected later this year.
If approved, we believe lebrikizumab has the potential to be the preferred first-line treatment option for people with moderate-to-severe atopic dermatitis.
Murase J., et al. Improved and Cleared Facial and Hand Dermatitis With Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis. 2023 Revolutionizing Atopic Dermatitis. April 30, 2023.
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