Dermatology Times 2025 Year in Review: Atopic Dermatitis

Atopic dermatitis (AD) treatment continued its rapid evolution in 2025 with expanded indications for pediatric populations, advanced topical therapies, and deeper insight into systemic treatment efficacy and safety. Across regulatory decisions and late-phase clinical trials, practice patterns have increasingly embraced pathogenesis-based strategies while maintaining foundational skin care principles. This year, Dermatology Times covered key regulatory milestones, late-phase outcomes, emerging agents, and an updated clinical framework to guide care.

Regulatory Milestones and Approved Therapies

One of the year’s most impactful developments is the growing portfolio of nonsteroidal topicals and expanded pediatric approvals. These actions reflect a broader trend toward targeted, steroid-sparing therapies that can be safely used early in disease course and across a wide age spectrum. Biologics targeting key cytokines also remain a cornerstone for moderate to severe disease, reinforcing the transition from broad immunosuppression to precision immunomodulation.

• FDA Approval Brings New Nonsteroidal Option for Pediatric AD: The US Food and Drug Administration (FDA) expanded the indication for ruxolitinib cream (Opzelura; Incyte) to include children aged 2 to 11 years with mild to moderate AD, making this the first topical JAK inhibitor available for this age range and offering a non-corticosteroid option with a strong safety and itch relief profile supported by phase 3 data.
• FDA Expands Roflumilast Access to Children as Young as Age 2: Additionally, roflumilast cream 0.05% (Zoryve; Arcutis) received FDA approval for children 2 to 5 years with mild to moderate disease, delivering a once-daily, steroid-free PDE-4 inhibitory option that reduces inflammation with minimal irritation — especially meaningful for sensitive areas and parental steroid concerns.
• Highlighting Major Breakthroughs for Atopic Dermatitis and Psoriasis in 2025: Agents such as dupilumab, lebrikizumab, and other IL-13–targeted therapies continued to be highlighted for robust efficacy and safety across diverse patient populations and clinical settings in late-phase confirmatory analyses.
• Castle Biosciences Launches 487-Gene Test for AD Care: Castle Biosciences’ AdvanceAD-Tx, a 487-gene expression profile (GEP) test, uses molecular signatures from lesional skin to guide systemic therapy decisions in moderate to severe AD.

Late-Phase Data and Pipeline Progress

Several investigational agents targeting immune regulation beyond classical type 2 cytokines are advancing with large-scale randomized trials. These pipeline efforts, including modulation of regulatory T cells and alternate interleukin pathways, reflect a deeper understanding of AD immunobiology and the goal of achieving greater disease remission with fewer flares.

• Rezpegaldesleukin Receives Fast Track Designation for Moderate to Severe AD: Nektar Therapeutics’ investigational biologic targets the IL-2 receptor complex in patients 12 years and older.
• CAGE Bio Reports Strong Phase 2b Results for CGB-500 in AD: The study found that 59% of patients achieved IGA treatment success, surpassing other topical therapies.
• Sanofi's OX40L Inhibitor Amlitelimab Shows Positive Results in Phase 3 AD Trial: Amlitelimab shows promising phase 3 results in treating AD, achieving significant skin clearance and potential for infrequent dosing.
• Upadacitinib Sustains AD Control for 140 Weeks: Upadacitinib maintained high EASI and itch response rates through nearly 3 years of treatment.
• LEO Pharma Presents Late-Breaking Results on Temtokibart for Atopic Dermatitis at EADV: LEO Pharma unveils promising phase 2b trial results for temtokibart, showcasing significant improvements in AD at EADV Congress 2025.
• Sitryx Advances Novel Oral Therapy SYX-5219 for Atopic Dermatitis with FDA IND Clearance: Sitryx Therapeutics advances SYX-5219 for moderate to severe AD, aiming for a first-in-class oral treatment with potential for lasting disease remission.
• Nemolizumab Maintains Long-Term Efficacy in AD: In the ARCADIA LTE, nemolizumab maintained significant and progressive improvements in skin and itch outcomes for up to 104 weeks.
• Topical Pan-JAK Inhibitor LNK01004 Shows Promising Efficacy and Safety in Phase 2 AD Trial: Lynk Pharmaceuticals reveals promising phase 2 trial results for LNK01004, a topical treatment showing efficacy and safety in moderate-to-severe AD.

Evolving Challenges and Opportunities in Disease Management

New evidence from 2025 hopes to address access barriers, treatment affordability, and optimization of long-term remission strategies, particularly in those with comorbidities. This emphasizes precision, safety, and patient-centered decision-making, balancing innovative options with foundational care principles.

• Pediatric AD Disparities in the United States: An Updated Review: Recent literature shows that children from racial minority groups with lower-income families have higher disease prevalence but reduced access to care.
• Prolonged Use of Oral Corticosteroids in Atopic Dermatitis Linked to Increased Cardiovascular Risks: Extended oral corticosteroid therapy in patients with AD significantly increases cardiovascular and thrombotic risks, urging careful treatment evaluations.
• Atopic Dermatitis Associated With Higher Dementia Risk: Through a comprehensive review and meta-analysis, researchers identified the correlation between AD and dementia.
• Severe Alopecia Areata Linked to Higher Atopic Dermatitis Risk: A recent study reveals a significant link between alopecia areata severity and increased risk of AD, especially in adolescents.
• Global Survey Uncovers Misalignment in AD Treatment Guidelines for Pregnant Women: New survey data reveals gaps in AD treatment for pregnant women, highlighting the need for updated guidelines and better physician education.
• Evaluating Product Safety Profiles in Eczema Care: A Closer Look at the NEA Seal of Acceptance: Discover how the NEA Seal of Acceptance helps clinicians recommend safe eczema products, ensuring quality and sensitivity for patients with AD.
• Global Study Links Atopic Eczema to Increased Risk of Suicidal Ideation: A new study at EADV 2025 links AD to increased suicidal ideation, highlighting the condition's severe psychological impact.
• Real-World Data Reveal Increased NMSC Risk in Atopic Dermatitis: Findings suggest immune dysregulation and chronic inflammation in AD may contribute to increased skin cancer susceptibility.
• Experts See Promise in AI for Atopic Dermatitis Care: Experts explore the integration of AI in AD management, highlighting benefits, risks, and the need for cautious implementation in patient care.