September 6, 2022: “Twenty-five scientific abstracts evaluating Dupixent® (dupilumab) in moderate-to-severe atopic dermatitis from infancy to adulthood, prurigo nodularis and chronic spontaneous urticaria will be presented at the European Academy of Dermatology and Venereology (EADV) 2022 Congress from September 7 to 10.
The data add to a growing body of clinical and real-world evidence illustrating the potential benefit of Dupixent in targeting IL-4 and IL-13, key and central drivers of the type 2 inflammation that plays a role in these inflammatory skin diseases.
New analyses from the pivotal trial in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis will be shared across eight posters.
Data presentations will show dupilumab plus low-potency topical corticosteroids significantly improved quality of life and sleep quality for both children and their caregivers.
Presentations will also show that children aged 6 months to 5 years treated with dupilumab experienced improvement in skin pain and that dupilumab treatment was associated with lower overall infections and non-herpetic skin infections in this age group.
The safety results of this pivotal trial were generally consistent with the known safety profile of dupilumab in atopic dermatitis.
Data in patients with moderate-to-severe atopic dermatitis aged 6 years and older will also be presented. Presentations of analyses from an open-label trial evaluating skin barrier function (BALISTAD) in patients 12 years and older will show Dupixent normalized skin barrier function for many patients and was associated with improvements in disease signs and symptoms and quality of life.
In a separate Phase 4 randomized, placebo-controlled trial in adults assessing the effect of Dupixent on sleep (DUPISTAD), analyses will be presented showing that Dupixent treatment improved sleep quality, daytime sleepiness, symptoms of anxiety and depression, health-related quality of life measures and itch, including in patients who switched to Dupixent from placebo.
The safety results of this pivotal trial were generally consistent with the known safety profile of Dupixent in atopic dermatitis.
Late-breaking results from a Phase 3 dupilumab trial showing improvement in signs and symptoms in adults with prurigo nodularis will also be presented.
The potential uses of dupilumab in prurigo nodularis, chronic spontaneous urticaria and bullous pemphigoid are currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.
Data to be presented at the EADV 2022 Congress
Investigation of Dupilumab in Prurigo Nodularis
- Late-breaking oral presentation (4:45-5:00 pm CEST):
- #3583: Dupilumab Significantly Improves Itch and Skin Lesions in Patients with Prurigo Nodularis: Results from a 2nd Phase 3 Trial (LIBERTY-PN PRIME), Gil Yosipovitch
Investigation of Dupilumab in Chronic Spontaneous Urticaria
- Poster #P1754: Dupilumab Significantly Reduces Itch and Hives in Patients With Chronic Spontaneous Urticaria Irrespective of Baseline IgE Level: Results From a Phase 3 Trial (LIBERTY-CSU CUPID Study A), Marcus Maurer
Study Design for Dupilumab in Bullous Pemphigoid
- Poster #P0404: The Study Design of a Trial of Dupilumab in Adult Patients With Bullous Pemphigoid: LIBERTY-BP ADEPT, Dedee Murrell
Clinical Efficacy and Safety of Dupilumab in Infants and Young Children with Atopic Dermatitis
- Poster #P0322: Dupilumab Treatment Improves Health-Related Quality of Life in Children Aged 6 Months to 5 Years with Moderate-to-Severe Atopic Dermatitis and Their Caregivers, Amy Paller
- Poster #P0321: Dupilumab Treatment Improves Sleep Quality in Children Aged 6 Months to 5 Years With Moderate-to-Severe Atopic Dermatitis and Their Caregivers, Amy Paller
- Poster #P0297: Dupilumab Treatment Is Not Associated With an Increased Overall Risk of Infections in Patients Aged 6 Months to 5 Years With Moderate-to-Severe Atopic Dermatitis, Michael Cork
- Poster #P0320: Dupilumab Treatment Reduces Skin Pain in Infants and Young Children With Moderate-to-Severe Atopic Dermatitis Aged 6 Months to 5 Years, Amy Paller
- Poster #P0290: Dupilumab Treatment Shows Rapid and Consistent Improvement in Atopic Dermatitis in All Anatomical Regions in Patients Aged 6 Months to 5 Years, Andreas Wollenberg
- Poster #P0356: Laboratory Safety From a 16-Week Phase 3 Study of Dupilumab in Patients Aged 6 Months to 5 Years With Moderate-to-Severe Atopic Dermatitis, Amy Paller
- Poster #P0354: Clinically Meaningful Within-Patient Change Threshold for the Children’s Dermatology Life Quality Index and Infants’ Dermatitis Quality of Life Index Instruments in Patients Aged 6 Months to <6 Years With Atopic Dermatitis, Amy Paller
- Poster #P0199 Meaningful Change Threshold for the Dermatitis Family Impact (DFI) Questionnaire for Parents/Caregivers of Children Aged 6 Months to <6 Years With Atopic Dermatitis (AD), Amy Paller
BALISTAD Skin Barrier Trial of Dupilumab in Atopic Dermatitis
- Poster #P0319: Dupilumab Treatment Normalizes Skin Barrier Structure and Function and Improves Quality of Life in Adult and Adolescent Patients With Moderate-to-Severe Atopic Dermatitis, Robert Bissonnette
- Poster #P0317: Dupilumab Treatment Normalizes Skin Barrier Function and Improves Clinical Outcomes in Patients With Atopic Dermatitis, Robert Bissonnette
DUPISTAD Sleep Trial of Dupilumab in Atopic Dermatitis
- Poster #P0328: Dupilumab ameliorates sleep disturbance and relieves itch in adults with moderate-to-severe atopic dermatitis over 24 weeks, Joseph Merola
- Poster #P0331: Improvement in sleep quality anxiety and depression in adults with moderate-to-severe atopic dermatitis with dupilumab treatment, Joseph Merola
- Poster #P0332: Improvement in symptoms of atopic dermatitis (AD) and AD-related quality of life with dupilumab treatment in adults: 24-week results of the DUPISTAD study, Joseph Merola
Clinical and Real-World Efficacy and Safety of Dupilumab in Atopic Dermatitis
- Oral Presentation (September 8, 10:45-10:55 am CEST):
- #FC02.04: Real-world treatment outcomes for up to 2 years in patients aged less than 12 years with inadequately controlled moderate-to-severe atopic dermatitis, Amy Paller
- Poster #P0323: Dupilumab 16-Week Efficacy and Safety Is Robust and Consistent in Adults Over 60 Years of Age With Moderate-to-Severe Atopic Dermatitis, Johnathan Silverberg
- Poster #P0312: Dupilumab Treatment Leads to Rapid, Progressive, and Sustained Reduction in Lichenification in Children, Adolescents, and Adults With Atopic Dermatitis, Emma Guttman-Yassky
- Poster #P0313: Dupilumab Treatment Leads to Rapid, Progressive and Sustained Reduction in Lichenification in White, African American/Black and Asian Patients With Atopic Dermatitis, Emma Guttman-Yassky.”
https://www.sanofi.com/en/media-room/press-releases/2022/2022-09-06-05-00-00-2509982
