16 Feb Lilly Announces Phase 3 Results for Atopic Dermatitis Treatment
MedicalResearch.com Interview with:
Lotus Mallbris, MD PhD
Dermatologist and Vice President, Head of Global Immunology Drug Development
Platform Team Leader at Lilly
MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by atopic dermatitis? How common is this condition?
Response:The BREEZE-AD1 and BREEZE-AD2 clinical trials are multicenter, randomized, double-blind, placebo-controlled, Phase 3 studies to evaluate the efficacy and safety of baricitinib monotherapy in adult patients with moderate to severe atopic dermatitis. These are two of five studies that will be part of the placebo-controlled data program intended to support global registrations.
Atopic dermatitis, a serious form of eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body. It affects approximately 1-3 percent of adults worldwide.
MedicalResearch.com: How does baricitinib differ from other treatments for atopic dermatitis?
Response: There are limited treatment options for atopic dermatitis available, particularly oral medications. Since we have not conducted any head-to-head studies, we cannot make direct comparisons between the clinical effects of the two medicines. We can only discuss the findings of our own clinical trials and are not in the position to discuss the efficacy and safety of other companies’ products.
MedicalResearch.com: What are the main findings?
Response: Baricitinib met the primary endpoint in the BREEZE-AD1 and BREEZE-AD2 studies. Compared to placebo, a significant improvement in disease activity was determined by the proportion of patients on baricitinib achieving clear (0) or almost clear skin (1) with a greater than or equal to 2-point improvement as measured by the 5-point Investor’s Global Assessment for AD (IGA) scale at 16 weeks of treatment.
In the 16-week placebo-controlled phase of BREEZE-AD1 and BREEZE-AD2, the incidence of treatment-emergent adverse events and serious adverse events with baricitinib treatment was similar to placebo, and the most common treatment-emergent adverse events observed were nasopharyngitis and headache. No venous thromboembolic events (VTEs), major adverse cardiovascular events (MACE), or deaths were reported.
MedicalResearch.com: What should readers take away from your report?
Response: There remain significant unmet medical needs for the care of people with atopic dermatitis, a chronic, often difficult-to-treat inflammatory skin disease, that can negatively impact patients’ quality of life. Atopic dermatitis can vary greatly from patient to patient, and despite recent advancements, there are still limited oral systemic treatments for the management of moderate to severe disease.
Lilly is encouraged that baricitinib met the primary endpoints in these two studies and looks forward to seeing the collective results of all five studies.
MedicalResearch.com: What are the next steps in the development of baricitinib?
Response: Full data results from both the BREEZE-AD1 and BREEZE-AD2 studies will be shared at future scientific venues and in peer-reviewed journals, as well as the top-line data from other ongoing Phase 3 trials later this year.
Lilly continues to enroll Phase 3 trials for baricitinib for the treatment of systemic lupus erythematous (SLE), for which the clinical development program recently received Fast Track designation from the FDA. Lilly has also commenced a Phase 2/3 trial for baricitinib for the treatment of severe or very severe alopecia areata.
Disclosures: Lotus Mallbris is the vice president of immunology development at Lilly and a dermatologist
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Last Updated on February 19, 2019 by Marie Benz MD FAAD