Core Insights - The BRAVE-AA-PEDS trial is the first and largest study focused on children and adolescents with severe alopecia areata, showing that 71% of adolescents treated with baricitinib 4 mg achieved successful scalp hair regrowth at one year [1][2][4] - Eli Lilly plans to submit the trial data to global regulators for a potential label update for baricitinib, commercially known as Olumiant [1][9][10] Group 1: Trial Results - At one year, 54.1% of patients receiving baricitinib 4 mg and 31% receiving baricitinib 2 mg achieved successful hair regrowth, defined as 80% or more scalp hair coverage [7] - Among patients with severe disease, 71% receiving baricitinib 4 mg and 58.6% receiving baricitinib 2 mg achieved successful hair regrowth [7] - In a post-hoc analysis, 80% of adolescents diagnosed with severe AA less than two years before treatment achieved successful hair regrowth with baricitinib 4 mg [4] Group 2: Safety Profile - The safety profile of baricitinib in adolescents was consistent with that seen in adult trials, with no new safety signals observed after one year [5][8] - Common treatment-emergent adverse events included acne, upper respiratory tract infection, and influenza, with no deaths or major adverse cardiovascular events reported [5][8] Group 3: Future Plans and Context - Lilly intends to enroll a new cohort of children ages 6 to under 12 in the BRAVE-AA-PEDS trial in the next year [9][12] - Baricitinib is the most-researched JAK inhibitor in alopecia areata, with over 1,300 adults and 423 adolescents enrolled in clinical trials [10]

Core Insights - Eli Lilly's EBGLYSS (lebrikizumab-lbkz) shows promising results in treating moderate-to-severe atopic dermatitis, with approximately 80% of patients achieving or maintaining meaningful skin improvement with less frequent dosing [1][5] - The company has submitted new data to the FDA for a potential label update, which could allow for a maintenance dosing schedule of once every eight weeks [1][3] Group 1: Clinical Data and Efficacy - In the Phase 3 ADjoin extension trial, patients receiving EBGLYSS every eight weeks achieved similar disease control rates as those receiving it every four weeks, with 79% and 86% achieving EASI 75, respectively [5][9] - The study also reported that 62% of patients on the eight-week regimen and 73% on the four-week regimen achieved IGA 0 or 1, indicating significant skin clearance [5][9] - There were no new safety findings or increased risk of immunogenicity associated with the less frequent dosing [5][9] Group 2: Treatment Flexibility and Patient Experience - The new dosing schedule could reduce the treatment burden for patients, allowing for as few as six maintenance doses per year, which may enhance patient adherence and quality of life [2][3] - The interleukin-13 (IL-13) inhibitor mechanism of EBGLYSS targets a key cytokine involved in atopic dermatitis, potentially offering a more effective treatment option for patients [2][20] Group 3: Regulatory and Market Position - Lilly is pursuing an FDA label update for the every-eight-week dosing option, while also exploring a twelve-week dosing regimen in ongoing studies [4][3] - EBGLYSS is positioned as a first-line biologic treatment for moderate-to-severe atopic dermatitis, with strong recommendations from the American Academy of Dermatology [4][8] Group 4: Commercial Strategy and Access - Lilly has secured coverage for EBGLYSS with all three major national pharmacy benefit managers, ensuring access for over 90% of individuals with commercial insurance [25] - The company is also working to expand Medicaid and Medicare coverage as part of its health access initiative [25]

Core Insights - Eli Lilly and Incyte presented late-breaking results showing that 42.4% of adolescents treated with baricitinib 4 mg achieved 80% or more scalp hair coverage at Week 36, indicating significant hair regrowth potential for severe alopecia areata [1][2][3] - The Phase 3 BRAVE-AA-PEDS study demonstrated that baricitinib can provide clinically meaningful improvements in hair regrowth for adolescents, with results comparable to those seen in adults after a longer treatment duration [2][3] - Baricitinib is positioned as a leading treatment option for severe alopecia areata, with ongoing studies expected to provide further data and regulatory discussions in the near future [2][5] Study Results - In the BRAVE-AA-PEDS study, 257 patients were randomized to receive either baricitinib 4 mg, 2 mg, or placebo, with the primary endpoint being a SALT score of ≤20 at Week 36 [1][7] - At Week 36, 60.0% of patients on baricitinib 4 mg and 36.9% on 2 mg saw at least a 50% improvement in their disease, compared to only 5.7% on placebo [3] - Significant eyebrow and eyelash regrowth was also observed, with 50.0% and 42.9% of patients on baricitinib 4 mg achieving notable improvements, respectively [3] Safety Profile - The most common treatment-emergent adverse events included acne, influenza, and upper respiratory tract infections, with a higher frequency of serious adverse events in the placebo group [4] - The safety profile of baricitinib in adolescents aligns with previous findings in trials for juvenile idiopathic arthritis and atopic dermatitis, indicating a consistent safety record [4][5] Regulatory and Market Position - Baricitinib, marketed as Olumiant, is already approved for adult patients with severe alopecia areata and has received regulatory approval for other conditions, including rheumatoid arthritis and atopic dermatitis [5][6] - The company plans to present additional data from the BRAVE-AA-PEDS study at scientific meetings and submit results for peer-reviewed publication, reinforcing its commitment to advancing treatment options for alopecia areata [5][6]