J Clin Aesthet Dermatol. 2025;18(5–6 Suppl 1):24–26.
April 9–13, 2025, in Rio Grande, Puerto Rico
Atopic Dermatitis
Growth analysis in children aged 6 to 11 years with severe atopic dermatitis and impact of up to 52 weeks of dupilumab treatment on height
Presenters: Alan D. Irvine,1 Amy S. Paller,2,3 Elaine C. Siegfried,4,5 Michael J. Cork,6,7 Lisa A. Beck,8 Zhen Chen,9 Carlos Peralta,10 Annie Zhang,11 Stephane Levy,9 Sonya L. Cyr,9
Affiliations: 1School of Medicine, Trinity College Dublin, Dublin, Ireland; 2Northwestern University Feinberg School of Medicine, Chicago, IL, USA; 3Ann and Robert H. Lurie Children’s Hospital, Chicago, IL, USA; 4Saint Louis University, St. Louis, MO, USA; 5Cardinal Glennon Children’s Hospital, St. Louis, MO, USA; 6Sheffield Dermatology Research, University of Sheffield, Sheffield, UK; 7Sheffield Children’s Hospital, Sheffield, UK; 8University of Rochester Medical Center, Rochester, NY, USA; 9Regeneron Pharmaceuticals Inc, Tarrytown, NY, USA; 10Sanofi, Amsterdam, Netherlands; 11Sanofi, Cambridge, MA, USA
Introduction: Children with severe atopic dermatitis (AD) were found to have significantly higher odds of height below the 25th percentile of United States Centers for Disease Control and Prevention (CDC) growth reference curves.1 We report the proportion of children aged 6 to 11 years with severe AD and lower stature who achieve a ≥5 percentile improvement in height following treatment with dupilumab over 52 weeks.
Methods: Height and weight were recorded for children in LIBERTY AD PEDS (NCT03345914), a Phase 3, placebo-controlled 16-week trial and LIBERTY AD PED-OLE (NCT02612454), an open-label extension trial where all eligible patients received dupilumab. The proportion of patients (below 25th height percentile at parent study baseline) with change from baseline in height percentile ≥5 was reported at Week 16 and Week 52.
Results: At Week 16, a greater proportion of children in the under 25th height percentile at parent study baseline achieved ≥5 height percentile improvement when treated with dupilumab for 16 weeks, compared to placebo [11.9% placebo (N=42) vs. 30.6% dupilumab (N=62), P=0.03]. At Week 52, placebo recipients in the under 25th height percentile at parent study baseline who transitioned to dupilumab increased by ≥5 height percentile in similar proportion to children treated with dupilumab from the start of the parent study [73.0% placebo transitioned to dupilumab (N=39) vs. 69.1% dupilumab (N=59), P=0.55].
Conclusion: In children, management of AD with dupilumab could benefit those whose growth tracks along the lower percentiles, by improving vertical growth.
Dupilumab consistently reduces CCL-17 (TARC) in patients with atopic dermatitis across all age groups
Presenters: Lisa A. Beck,1 Mark Boguniewicz,2,3 Yoko Kataoka,4 Marjolein de Bruin-Weller,5 Antonella Muraro,6 Zhen Chen,7 João Costa,8 Ainara Rodríguez Marco,9 Parul Shah,7 Ana B. Rossi,10
Affiliations: 1Department of Dermatology, University of Rochester Medical Center, Rochester, NY, USA; 2Division of Allergy-Immunology, Department of Pediatrics, National Jewish Health, Denver, CO, USA; 3University of Colorado School of Medicine, Denver, CO, USA; 4Department of Dermatology, Osaka Habikino Medical Center, Osaka, Japan; 5National Expertise Center of Atopic Dermatitis, Department of Dermatology and Allergology, University Medical Center, Utrecht, Netherlands; 6Food Allergy Referral Centre, Padua University Hospital, Padua, Italy; 7Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA; 8Sanofi, Porto Salvo, Portugal; 9Sanofi, Madrid, Spain; 10Sanofi, Cambridge, MA, USA
Introduction: C-C motif chemokine 17 [CCL17; also known as thymus and activation-regulated chemokine (TARC)], is a key chemokine for attracting inflammatory cells into the target tissue, including Th2 lymphocytes and eosinophils. In atopic dermatitis (AD), CCL17/TARC is primarily secreted from keratinocytes, and serum CCL17/TARC levels are known to be correlated with severity of disease. Elevated levels of CCL17/TARC (collected by skin tape strips) has been shown to precede the development of childhood AD. Skin biopsies in patients with AD treated with dupilumab have shown marked local reductions in expression of Type 2 inflammatory pathway genes, including CCL17/TARC. The objective of this study is to determine the effect of dupilumab treatment on serum CCL17/TARC levels across all age groups.
Methods: We report serum CCL17/TARC (human TARC Quantikine ELISA kit; R&D Systems) levels from patients with moderate-to-severe or severe AD enrolled in the following randomized, double-blind, placebo-controlled Phase 3 studies, receiving approved dupilumab dose regimens: LIBERTY AD PRESCHOOL (aged 6 months to 5 years; NCT03346434 part B); LIBERTY AD PEDS (aged 6 to 11 years; NCT03345914); LIBERTY AD ADOL (aged 12 to 17 years; NCT03054428); LIBERTY AD SOLO1 (aged 18 years or older; NCT02277743); LIBERTY AD SOLO2 (aged 18 years or older; NCT02277769). Both LIBERTY AD PRESCHOOL and LIBERTY AD PEDS studies allowed concomitant TCS use.
Results: There was a significant reduction, compared to placebo, in median percentage change from baseline in serum CCL17/TARC (pg/mL) in the combined dupilumab-treated arm across all age groups over 16 weeks (P<0.0001 at all the time points measured). At Week 16, reductions in serum levels of CCL17/TARC were about 80 percent from baseline across all age ranges. Reductions in serum CCL17/TARC levels were greater than 60 percent from baseline as early as after the first dose in all age ranges (P<0.0001 vs. placebo).
Conclusion: Across all age ranges, dupilumab treatment demonstrated rapid and sustained reduction of serum CCL17/TARC levels after the first dose. Serum CCL17/TARC levels likely reflect skin CCL17/TARC levels and could be associated with leukocyte infiltration in lesional skin.
Dupilumab treatment significantly reduces age-dependent total IgE levels in young children with atopic dermatitis
Presenters: Lisa A. Beck,1 Amy S. Paller,2,3 Elaine C. Siegfried,4,5 Lawrence F. Eichenfield,6,7 Alan D. Irvine,8 Eric L. Simpson,9 Eulalia Baselga,10 Peter Lio,2 Ana B. Rossi,11 Jiangnan Lyu,12 Sonya L. Cyr,12
Affiliations: 1University of Rochester Medical Center, Rochester, NY, USA; 2Northwestern University Feinberg School of Medicine, Chicago, IL, USA; 3Ann and Robert H. Lurie Children’s Hospital, Chicago, IL, USA; 4Saint Louis University, St. Louis, MO, USA; 5Cardinal Glennon Children’s Hospital, St. Louis, MO, USA; 6University of California San Diego, La Jolla, CA, USA; 7Rady Children’s Hospital, San Diego, CA, USA; 8Trinity College Dublin, Dublin, Ireland; 9Oregon Health & Science University, Portland, OR, USA; 10Hospital Sant Joan de Déu, Barcelona, Spain; 11Sanofi, Cambridge, MA, USA; 12Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA
Introduction: Elevated IgE contributes to pathophysiology of atopic conditions such as food allergies and asthma. In atopic dermatitis (AD), IgE sensitization is associated with increased severity and flares, and correlates with atopic comorbidity development, especially in young children. Dupilumab treatment was shown to reduce IgE levels in pediatric, adolescent, and adult patients. Recent literature suggests that reduction of IgE sensitization might contribute to preventing atopic comorbidity development in children. We evaluated impact of age, and dupilumab treatment over time on IgE levels in children with moderate-to-severe AD aged 0.5–<6 years.
Methods: In LIBERTY AD PRESCHOOL (NCT03346434), patients aged 6 years or under with moderate-to-severe AD received dupilumab or placebo with TCS. We report baseline and Week 16 total IgE levels stratified by age, and the Week 16–baseline IgE ratio and difference. Dupilumab versus placebo comparisons were done using a mixed effect model for repeated measures.
Results: Baseline mean IgE levels (IU/mL) showed age-dependent increase in dupilumab (n=71) and placebo (n=69) groups (0.5–<2yrs, 3,481.8 and 636.3 respectively; ≥2–<4yrs, 5,736.4 and 5,066.7; ≥4–<6 years, 10,046.0 and 9,044.9). At Week 16, dupilumab significantly reduced IgE levels (IgE ratio, P<0.001; IgE difference, P=0.001) vs. placebo in all cohorts (0.5–<2yrs, 275.9 vs 918.0; ≥2–<4yrs, 1,233.3 vs 4,960.0; ≥4–<6yrs, 3,932.8 vs. 9,510.4).
Conclusion: IgE levels increase with age in children with moderate-to-severe AD. Dupilumab significantly curbed IgE level increases in all tested age cohorts. Reduction in IgE levels with dupilumab in children with AD might contribute to lowering the risk of developing atopic comorbidities.
Psoriasis
Frequency and patient-reported impact of psoriatic arthritis and other comorbidities in patients with moderate-to-severe psoriasis from the VISIBLE trial
Presenters: Linda Stein Gold,1 George Han,2 Mona Shahriari,3 Tina Bhutani,4 Olivia Choi,5 Theodore Alkousakis,5 Katelyn Rowland,5 Adrian O. Rodriguez,6 Geeta Yadav,7 Jensen Yeung,8 Tony Ma,9 Long-Long Gao,9 Daphne Chan,5 Lawrence Green,10 Aaron S. Farberg,11 Shawn Kwatra,12 Andrew Alexis13
Affiliations: 1Henry Ford Medical Center, West Bloomfield, MI, USA; 2Northwell Health Physician Partners, New York, NY, USA; 3Yale University School of Medicine and Central Connecticut Dermatology, New Haven, CT, USA; 4Synergy Dermatology, San Francisco, CA, USA; 5Johnson & Johnson, Horsham, PA, USA; 6Nashville Skin Comprehensive Dermatology Center, Nashville, TN, USA; 7FACET Dermatology, Toronto, ON, Canada; 8University of Toronto, Toronto, ON, Canada; 9Johnson & Johnson, Spring House, PA, USA; 10George Washington University School of Medicine, Rockville, MD, USA; 11Bare Dermatology, Dallas, TX, USA; 12University of Maryland School of Medicine, Baltimore, MD, USA; 13Weill Cornell Medicine, New York, NY, USA
Introduction: Psoriasis frequently occurs with concomitant psoriatic arthritis (PsA) and/or cardiometabolic comorbidities. VISIBLE, a study dedicated to people of color with moderate-to-severe body (Cohort-A) or scalp (Cohort-B) predominant plaque psoriasis, provides insights about psoriatic comorbidities in a diverse population.
Methods: VISIBLE participants were randomized 3:1 to guselkumab 100mg or placebo (Week [W]0, W4, then q8w), with placebo-to-guselkumab crossover at W16. Comorbid cardiometabolic conditions were identified per medical history (MedDRA preferred terms) and/or laboratory values/vitals. PsA was defined by history of rheumatologist-confirmed diagnosis or screening Psoriasis Epidemiology Screening Tool (PEST) score ≥3. Patient-reported PsA burden was assessed by PsA Impact of Disease 12-item questionnaire (PsAID-12) among participants with PsA.
Results: At baseline, Cohort A (N=103)/Cohort B (N=108) participants were identified as having hypertension (67.0%/59.3%), diabetes (23.3%/20.4%), dyslipidemia (76.7%/66.7%), and metabolic syndrome (38.8%/25.9%) per medical history or labs/vitals. Notably, how comorbidities were identified provides insights: 1) comorbid disease identified by medical history without in-study out-of-range labs/vitals indicate a known, well-controlled comorbidity; 2) comorbidities identified without medical history and only via abnormal labs/vitals at study start reveal previously undiagnosed disease; and 3) comorbidities documented in medical history and also flagged via abnormal labs/vitals reveal likely suboptimally controlled disease. PsA, based on medical history or positive PEST at screening, was identified in 31.1 percent/27.5 percent of Cohort A/Cohort B participants at baseline (efficacy analysis set). Among guselkumab-randomized participants with PsA, baseline mean (SD) PsAID-12 scores were 6.4 (2.7)/5.9 (3.0), indicating substantial PsA burden at enrollment. Mean (SD) PsAID-12 scores indicative of patient-acceptable scores (≤3.95) were achieved at W16 (3.1 [2.7]/1.7 [1.6]) and sustained at W48 (2.6 [2.8]/1.4 [2.1]).
Conclusion: VISIBLE participants had high comorbid disease burden, including pre-existing PsA and cardiometabolic disease that was either undiagnosed or diagnosed but suboptimally controlled at enrollment. Follow-up of these comorbidities is ongoing over the two-year study period. Participants with PsA reported high impact at baseline but achieved rapid and clinically significant improvements with guselkumab at W16 that were maintained at W48. A holistic care model for patients with psoriatic disease is needed, where dermatologists are involved in identifying and referring comorbidities for further treatment and follow-up.
Icotrokinra, a targeted oral peptide that selectively blocks the interleukin-23–receptor, for the treatment of moderate-to-severe plaque psoriasis: Results through Week 24 of the Phase 3, randomized, double-blind, placebo-controlled ICONIC-LEAD trial
Presenters: Robert Bissonnette,1 Jennifer Soung,2 Adelaide Hebert,3 Andrew E. Pink,4 Andreas Pinter,5 Yuling Shi,6 Megan Miller,7 Joseph Cafone,7 Jing Zhi (Gigi) Jiang,8 Cynthia DeKlotz,7 Mark G. Lebwohl9
Affiliations: 1Innovaderm Research, Montreal, QC, Canada; 2Southern California Dermatology, Santa Ana, CA, USA; 3UTHealth McGovern Medical School, Houston, TX, USA; 4St John’s Institute of Dermatology, King’s College London and Guy’s and St Thomas’s Hospitals, London, UK; 5Department of Dermatology, University Hospital Frankfurt, Frankfurt am Main, Germany; 6Department of Dermatology, Shanghai Skin Disease Hospital, Institute of Psoriasis, Tongji University School of Medicine, Shanghai, China; 7Johnson & Johnson, Spring House, PA, USA; 8Johnson & Johnson, Milpitas, CA, USA; 9Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York City, NY, USA.
Introduction: Icotrokinra (ICO), a first-in-class, targeted oral peptide that selectively binds the interleukin (IL)-23–receptor and inhibits signaling, demonstrated significant, durable skin clearance and a safety profile similar to placebo in Phase 2 studies in plaque psoriasis. Findings from the first Phase 3 ICO study in participants with moderate-to-severe plaque psoriasis are reported.
Methods: The pivotal, Phase 3, double-blind, placebo-controlled ICONIC-LEAD trial (NCT06095115) randomized adults and adolescents (≥12–<18 years) with moderate-to- severe plaque psoriasis (body surface area [BSA] ≥10%; Psoriasis Area and Severity Index [PASI] ≥12; overall Investigator’s Global Assessment [IGA] ≥3) 2:1 to once-daily (QD) ICO 200mg through Week 24 or placebo through Week 16 followed by transition to ICO 200mg QD. Coprimary endpoints were IGA0/1 (clear [0]/almost-clear [1] skin and ≥2-grade improvement from baseline) and PASI90 (≥90% reduction from baseline in PASI) responses at Week 16.
Results: ICONIC-LEAD randomized 684 participants (ICO=456/placebo=228). The coprimary endpoints were met: 65 percent ICO- versus 8 percent placebo-treated participants achieved IGA0/1, and 50 percent versus 4 percent, respectively, achieved PASI90 at Week 16 (both P<0.001). ICO completely cleared skin at significantly higher rates than placebo at Week 16 (IGA0: 33% vs. 1%; PASI100: 27% vs <1%; both multiplicity adjusted P<0.001). ICO response rates continued to increase through Week 24, including IGA0/1 in 74 percent, PASI90 in 65 percent, IGA0 in 46 percent, and PASI100 in 40 percent of participants. Similar proportions of ICO- and placebo-treated participants had one or more adverse events (49% in each group; most commonly nasopharyngitis and upper respiratory tract infection) and similar proportions had one or more gastrointestinal event (6% per group) through Week 16. No safety signals emerged through Week 24.
Conclusion: ICO demonstrated significantly higher rates of skin clearance versus placebo and a favorable safety profile in adults and adolescents with moderate-to-severe plaque psoriasis.