Core Insights - Arcutis Biotherapeutics, Inc. is presenting five posters at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference, showcasing new data on the long-term safety and efficacy of ZORYVE cream in treating atopic dermatitis (AD) in children aged 2 to 5 [1][2] Group 1: Study Findings - The INTEGUMENT-OLE study demonstrated that ZORYVE cream 0.05% has long-term safety and durable efficacy in children aged 2 to 5 with AD, with a median duration of disease control of 238 days for those switching to a proactive twice-weekly application [2][5] - In the study, 32.7% of participants aged 6 years and older and 28.8% of participants aged 2 to 5 achieved a validated Investigator Global Assessment (vIGA-AD) score of clear or almost clear by Week 4, improving to 55.7% and 63.1% respectively by Week 52 [3][5] - Significant improvements in itch were observed, with 30.9% of participants aged 6 years and older and 41.2% of participants aged 2 to 5 achieving a clinically meaningful reduction in itch at the conclusion of the parent studies, improving to 55.3% and 60.7% respectively after up to 56 weeks of treatment [3][5] Group 2: Clinical Implications - The data highlight the critical need for effective, long-term, steroid-free treatment options for young children with AD, as chronic use of topical steroids can lead to significant adverse events [4][5] - ZORYVE cream formulations were well tolerated, with treatment-related adverse events reported in 4.7% of participants aged 6 years and older and 2.5% of participants aged 2 to 5 [4][5] - The investigational ZORYVE cream 0.05% is currently under FDA review, with a target action date of October 13, 2025, indicating potential for future market introduction [13]

Core Insights - Eli Lilly's EBGLYSS has shown significant long-term efficacy in treating moderate-to-severe atopic dermatitis, with 50% of patients achieving complete skin clearance and 87% achieving almost-clear skin after three years of treatment [1][20][24] - The drug was approved in the U.S. as a first-line monotherapy biologic treatment option in September 2024, following topical therapies [1][20] - EBGLYSS is an interleukin-13 (IL-13) inhibitor that effectively targets the inflammatory processes associated with atopic dermatitis [1][19] Efficacy and Study Results - In the ADjoin long-term extension study, 50% of patients receiving once-monthly maintenance doses achieved complete skin clearance (EASI 100 or IGA 0) at three years, while 87% maintained almost-clear skin (EASI 90) [1][5] - Over 83% of Week 16 responders did not require concomitant therapies such as topical corticosteroids during the study [1] - Additional studies (ADmirable and ADapt) demonstrated significant improvements in itch, skin pain, and sleep loss due to itch among diverse patient groups [1][26][27] Safety Profile - The safety profile of EBGLYSS in recent studies was consistent with previous Phase 3 studies, with no new safety signals reported [2] - Most adverse events were mild or moderate, with conjunctivitis and injection-site reactions being the most common treatment-related side effects [2] Market Position and Development - EBGLYSS is the only first-line biologic treatment option for patients with moderate-to-severe atopic dermatitis uncontrolled by topical therapies, offering a once-monthly maintenance dosing regimen [3][20] - Eli Lilly has exclusive rights for the development and commercialization of EBGLYSS in the U.S. and other regions outside Europe, while Almirall holds rights for European dermatology indications [3][20] Future Directions - Further data from the ADmirable study, focusing on patients with skin of color, is expected to be shared in 2025, indicating ongoing commitment to diverse patient populations [19][26]