Patients with Atopic Dermatitis Not on Systemic Therapy have High Rates of Severe, Uncontrolled Disease, and Considerable Impact on Quality of Life
Authors: Simpson Eric , Fenske Christian , Li Alvin , Dawson Zach , Maldonado Yolanda Muñoz , Ho Kaylee , Callahan Kayla , Gold Linda Stein , Desai Seemal , Golant Alexandra , DiRuggiero Douglas , Silverberg Jonathan I 
Published: January 2024

Patients with atopic dermatitis not on systemic therapy have high rates of severe, uncontrolled disease and considerable impact on quality of life
Eric Simpson1, Christian Fenske2, Alvin Li3, Zach Dawson2, Yolanda Muñoz Maldonado3, Kaylee Ho3, Kayla Callahan3, Linda Stein Gold4, Seemal Desai5, Alexandra Golant6, Douglas DiRuggiero7, Jonathan I Silverberg8
1Oregon Health & Science University, Portland, Oregon, USA; 2Eli Lilly and Company, Indianapolis, USA; 3CorEvitas LLC, Waltham, Massachusetts, USA; 4Henry Ford Health System, Michigan, USA; 5Innovative Dermatology, PA, Texas, USA; 5The University of Texas Southwestern Medical, Dallas, Texas, USA; 6Icahn School of Medicine at Mount Sinai, New York, USA; 7Skin Cancer and Cosmetic Dermatology Center, Rome, Georgia, USA; 8George Washington University School of Medicine and Health Sciences, Washington, DC, USA
Background: Decision to initiate a new systemic therapy (ST) among patients with atopic dermatitis (AD) is complex. This cross-sectional study explored overall disease burden, sociodemographic and clinical characteristics, and disease activity among patients with moderate-to-severe AD.
Methods: Adult patients with AD who had a vIGA-ADTM score ≥3 and Eczema Area Severity Index (EASI) score ≥12 at enrollment were identified from the prospective, longitudinal CorEvitas AD Registry between 07/21/2020 and 12/31/2022. Included patients were newly prescribed an eligible ST (ST group) or not prescribed an eligible ST (non-ST group) at enrollment. Patients on ST before enrollment were excluded. Sociodemographic characteristics, disease features, severity measures (vIGA-ADTM [0–4]; body surface area (BSA) [0–100%]; EASI [0–72]), and patient-reported outcomes (PROs) were assessed. PROs included Dermatology Life Quality Index (DLQI) [0-30], Itch/Pruritus Numeric Rating Scale [0-10], Patient-Oriented Eczema Measure (POEM) [0-26], and AD Control Tool (ADCT) [<7 controlled, >7 not controlled]. Differences in means or proportions of characteristics among ST and non-ST groups were summarized using effect sizes (ES).
Results: The study included 673 (mean age=50.7 years, 55.6% female) patients who were newly prescribed ST and 229 (47.8 years, 51.3%) who were not prescribed ST. The overall distribution of race (Whites 70.4% vs. 60.5%, Asians 8.6% vs. 17.5%, Black 13.7% vs. 8.3%, Other 7.3% vs. 13.6%; ES=0.17) and geographic region (West 8.5% vs. 28.4%, South 32.1% vs. 15.7%; ES=0.27) had small differences between the ST and non-ST groups. More patients (n=402 [59.7%]) in the ST group had severe AD (vIGA-ADTM=4), whereas moderate AD (vIGA-ADTM=3) was more common (n=137 [59.8%]) in the non-ST group. Higher disease severity was reported in the ST group versus non-ST group: BSA (mean [SD]: 41.6% [17.1] vs. 31.5% [16.0]; ES=0.61) and EASI (24.3 [10.1] vs. 19.8 [8.6]; ES=0.47). Mean [SD] PRO measures were also higher in the ST group compared to non-ST group: DLQI (11.7 [7.5] vs. 10.4 [7.9]; ES=0.17), mean peak pruritus in the past 24 hours (6.8 [2.9] vs. 6.1 [3.1]; ES=0.25), POEM (17.8 [7.1] vs. 16.6 [7.5]; ES=0.17), and ADCT (14.4 [6.1] vs. 13.0 [6.7]; ES=0.21).
Conclusion: Patients not initiating ST have high rates of severe, uncontrolled AD, and considerable burden from their disease, indicating potential delayed or undertreatment. Understanding the factors that influence the decision to escalate therapy in systemic-eligible patients is important for improving care of AD.

Disclosures
Eric Simpson: Dr. Simpson reports personal fees from Advances in Cosmetic Medical Derm Hawaii LLC, AbbVie, Amgen, AOBiome LLC, Arcutis Biotherapeutics, Arena Pharmaceuticals, Aslan Pharma, Boehringer-Ingelheim USA, Inc., Boston Consulting Group, Bristol Myers Squibb – BMS, Collective Acumen LLC (CA), CorEvitas, Dermira, Eli Lilly, Evelo Biosciences, Evidera, ExcerptaMedica, FIDE, Forte Bio RX, Galderma, GlaxoSmithKline, Incyte, Janssen, Johnson & Johnson, Kyowa Kirin Pharmaceutical Development, Leo Pharma, Medscape LLC, Merck, MauiDerm, MLG Operating, MJH holding, Pfizer, Physicians World LLC, PRImE, Regeneron, Revolutionizing Atopic Dermatitis Inc., Roivant, Sanofi-Genzyme, Trevi therapeutics, Valeant, Vindico Medical education, WebMD. Dr. Simpson reports grants (or serves as Principal investigator role) from AbbVie, Acrotech Biopharma Inc., Amgen, Arcutis, Aslan, Castle Biosciences, CorEvitas, Dermavant, Dermira, Eli Lilly, Incyte, Kymab, Kyowa Kirin, National Jewish Health, Leo, Pfizer, Regeneron, Sanofi, and Target RWE. These potential conflicts of interest have been reviewed and managed by OHSU.
Christian Fenske: Employment and stockholder, Eli Lilly and Company.
Alvin Li: Employee of CorEvitas, LLC and stockholder, Eli Lilly and Company.
Zach Dawson: Employment and stockholder, Eli Lilly and Company.
Yolanda Muñoz Maldonado: Employee of CorEvitas, LLC.
Kaylee Ho: Employee of CorEvitas, LLC.
Kayla Callahan: Employee of CorEvitas, LLC and stockholder, Eli Lilly and Company.
Linda Stein Gold: Investigator, advisor and/or speaker for Lilly, BMS, UCB, Pfizer, Sanofi, Regeneron, Dermavant, Arcutis, Sun, Incyte, Leo, Aslan.
Seemal Desai: Dr. Desai is currently performing paid consulting services. He has previously been an advisor for Lilly and also performed consulting and/or clinical for multiple organizations.
Alexandra Golant: Dr. Golant has received consulting or speaker fees from: Regeneron, Sanofi, AbbVie, Incyte, Dermavant, Lilly, Leo Pharma, Arcutis, Janssen, Amgen, Pfizer.
Douglas DiRuggiero: Industry speaker bureau and advisory boards: AbbVie, Amgen, Arcutis, BMS, Incyte, Janssen, Lilly, Novartis, Sanofi/Regeneron, UCB.
Jonathan I. Silverberg: Jonathan Silverberg has received honoraria as a consultant and/or advisory board member for AbbVie, AOBiome, Arcutis, Alamar, Amgen, Arena, Asana, Aslan, BioMX, Biosion, Bodewell, Boehringer-Ingelheim, Cara, Castle Biosciences, Celgene, Connect Biopharma, Dermavant, Dermira, Dermtech, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Kiniksa, Leo Pharma, Menlo, Novartis, Optum, Pfizer, RAPT, Regeneron, Sanofi-Genzyme, Shaperon, Union; speaker for AbbVie, Eli Lilly, Leo Pharma, Pfizer, Regeneron, Sanofi-Genzyme; institution received grants from Galderma, Pfizer.