Dupilumab Improves Clinical Scores in Children and Adolescents With Moderate to Severe Atopic Dermatitis: A Real-World, Single-Center Study

Pagan, Angel D; David, Eden; Ungar, Benjamin; Ghalili, Sabrina; He, Helen; Guttman‐Yassky, Emma

doi:10.1016/j.jaip.2022.06.014

Cited by 29 publications

(28 citation statements)

References 39 publications

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“…Previous analyses of clinical studies also showed that dupilumab significantly improved clinical signs, symptoms, and QoL across patients with AD in different life stages, for adults and adolescents with moderate-to-severe AD and for children with severe AD, with an acceptable safety profile [ 26 – 29 ]. These findings are supported by real-world experiences with dupilumab in children, adolescents, adults, and elderly with AD [ 21 , 30 – 32 ]. The similar efficacy of dupilumab, which inhibits key drivers of type 2-mediated inflammation, in the different age-of-onset subgroups analyzed in this study confirms the high clinical relevance of dysregulated type 2 inflammation in AD among different age-of-onset groups [ 14 , 15 ].…”

Section: Discussionsupporting

confidence: 65%

Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis is Efficacious Regardless of Age of Disease Onset: a Post Hoc Analysis of Two Phase 3 Clinical Trials

Silverberg

Boguniewicz

Hanifin

et al. 2022

Dermatol Ther (Heidelb)

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Introduction Adults with atopic dermatitis (AD) commonly report adult-onset disease. AD is associated with different genetics, lesion morphology and distribution, and symptoms by age of onset. Yet little is known about possible differences in treatment efficacy between adults with adult-onset or childhood-onset AD. Methods We evaluated the efficacy of dupilumab by age of AD onset in adults with moderate-to-severe AD, using pooled data from the LIBERTY AD SOLO 1 and 2 studies (NCT02277743, NCT02277769). Results were stratified based on self-reported age of AD onset, divided into four age subgroups: 0–4, 5–9, 10–19, and over 20 years. Results This analysis included 460 patients treated with placebo and 457 treated with dupilumab 300 mg every 2 weeks (q2w), with a mean patient age of 38 years. Most patients (53.2%) reported AD onset at 0–4 years, with 14% at 5–9 years, 13.4% at 10–19 years, and 18.5% at 20 years or older. Dupilumab significantly improved AD signs and symptoms over 16 weeks compared with placebo, regardless of age of onset. Dupilumab treatment resulted in a significantly greater proportion of patients achieving Eczema Area and Severity Index (EASI)-50, EASI-75, and EASI-90 (50%, 75%, and 90% improvement from baseline EASI, respectively), and clear or almost clear skin (Investigator’s Global Assessment score 0 or 1) across all age-of-onset subgroups compared with placebo. In addition, EASI improvements were significant across all anatomical regions in all subgroups. Weekly average peak pruritus Numerical Rating Scale and Dermatology Life Quality Index also improved consistently and significantly with dupilumab versus placebo, regardless of age of onset. Conclusion Despite possible differences in presentation and progression of AD linked to age of onset, dupilumab showed similar significant and sustained improvements in AD signs, symptoms, and quality of life in adults compared with placebo, over 16 weeks of treatment. Trial Registration LIBERTY AD SOLO 1: NCT02277743; LIBERTY AD SOLO 2: NCT02277769. Infographic available for this article.

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Section: Discussionsupporting

confidence: 65%

Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis is Efficacious Regardless of Age of Disease Onset: a Post Hoc Analysis of Two Phase 3 Clinical Trials

Silverberg

Boguniewicz

Hanifin

et al. 2022

Dermatol Ther (Heidelb)

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“…Te overall incidence of treatment-emergent adverse events was 7.7% in our pediatric cohorts during the 16-week dupilumab treatment period (Table 3), which was even lower than previous real-world studies in children aged 6-11 years (12.5%), adolescents (13.5%), and adults (17.5%) [14,15,18]. In fact, a larger regimen (Table 3) was partly administrated in our cohorts, which might further prove dupilumab a safe choice in pediatric patients, considering the low occurrence of adverse events.…”

Section: Discussioncontrasting

confidence: 58%

Dupilumab Improves Clinical Scores in Pediatric Patients Aged 2 to <18 Years with Uncontrolled Atopic Dermatitis: A Single‐Center, Real‐World Study

Wang

Shen

Liu

et al. 2023

Dermatologic Therapy

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Dupilumab is the first biologic agent approved for treatment of moderate to severe atopic dermatitis (AD). Phase 3 clinical trials have shown the efficacy and safety in AD children. However, real-world evidence is still scarce. Thirty-nine pediatric patients with uncontrolled AD who regularly received dupilumab were included in a single-center retrospective study. Eight patients (20.5%) were aged 2 to <6 years, fifteen (38.5%) were 6 to <12 years, and sixteen were 12 to <18 years. Changes in clinical AD scores (EASI, SCORAD, P-NRS, CDLQI, and POEM) at baseline, week 4 (W4), W10, and W16, as well as safety data were collected. At W16, the average EASI values dropped from 29.0 ± 16.2 to 5.1 ± 4.7, and 22 patients (73.3%) achieved 75% improvement in EASI. 16 patients (53.3%) achieved 75% improvement in SCORAD. Significant reduction was also observed in the changes of P-NRS, CDLQI, and POEM values. Notably, the change of clinical scores was similar among three age subgroups. At W16, the mean percent decreases in EASI for 2 to <6 years, 6 to <12 years, and 12 to <18 years, and subgroups were 67.3%, 78.5%, and 83.9%, respectively. A total of three cases of adverse effects were recorded, with conjunctivitis seen in two >6-year-old patients and the injection site reaction in one <6-year-old child. Dupilumab exhibited favorable efficacy and safety profile, including the 2 to <6 years old subgroup.

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“… 21 , 23 , 24 EASI‐75 was achieved by 42.0%–66.7% of the patients. 21 , 22 , 23 , 24 In the current study, the proportions of patients that achieved EASI‐50 and EASI‐75 after 16–28 weeks were 75.4%–78.7% and 42.6%–49.2%, respectively, which were within the range of the other daily practice studies. Other clinical outcomes used in the published daily practice studies differ from our study, making them difficult to compare.…”

Section: Discussionmentioning

confidence: 96%

“…All of these studies found a significant improvement of AD severity during dupilumab treatment. 21 , 22 , 23 , 24 , 25 , 26 , 27 After 16–24 weeks of treatment, EASI‐50 was achieved by 67.0%–99.3% of the patients. 21 , 23 , 24 EASI‐75 was achieved by 42.0%–66.7% of the patients.…”

Section: Discussionmentioning

confidence: 99%

“… 21 , 22 , 23 , 24 , 25 , 26 , 27 After 16–24 weeks of treatment, EASI‐50 was achieved by 67.0%–99.3% of the patients. 21 , 23 , 24 EASI‐75 was achieved by 42.0%–66.7% of the patients. 21 , 22 , 23 , 24 In the current study, the proportions of patients that achieved EASI‐50 and EASI‐75 after 16–28 weeks were 75.4%–78.7% and 42.6%–49.2%, respectively, which were within the range of the other daily practice studies.…”

Section: Discussionmentioning

confidence: 99%

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Dupilumab in daily practice for the treatment of pediatric atopic dermatitis: 28‐week clinical and biomarker results from the BioDay registry

Kamphuis

Boesjes

Loman

et al. 2022

Pediatric Allergy Immunology

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Background: Dupilumab has proven to be an effective and safe treatment for atopic dermatitis (AD) in pediatric patients in clinical trials. However, few daily practice studies are available. The aim of this study is to evaluate the effect of 28 weeks dupilumab treatment on effectiveness, safety, and serum biomarkers in pediatric patients with moderate-to-severe AD in daily practice. Methods: Patients visited the outpatient clinic at baseline, 4, 16, and 28 weeks of treatment. Disease severity was assessed by the Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), Numeric Rating Scale (NRS)-pruritus and -pain, and the Patient-Oriented Eczema Measure (POEM). Side effects were evaluated. Nineteen severity-associated serum biomarkers were measured. Predicted-EASI (p-EASI) was calculated.Results: Sixty-one patients were included. Respectively 75.4%, 49.2%, and 24.6% reached clear. Improvement of ≥4 points on POEM, NRS-pruritus, and NRS-pain was reached by 84.7%, 45.3%, and 77.4%, respectively. Most reported side effects were conjunctivitis (n = 10) and headache (n = 4). Biomarkers TARC, PARC, periostin, sIL-2Ra, and eotaxin-3 significantly decreased during treatment. The p-EASI showed a significant correlation with disease severity. Conclusion:Dupilumab treatment significantly improved disease severity and diseaseassociated symptoms and decreased severity-associated serum biomarkers in pediatric AD patients in daily practice.

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Dupilumab Improves Clinical Scores in Children and Adolescents With Moderate to Severe Atopic Dermatitis: A Real-World, Single-Center Study

Cited by 29 publications

References 39 publications

Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis is Efficacious Regardless of Age of Disease Onset: a Post Hoc Analysis of Two Phase 3 Clinical Trials

Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis is Efficacious Regardless of Age of Disease Onset: a Post Hoc Analysis of Two Phase 3 Clinical Trials

Dupilumab Improves Clinical Scores in Pediatric Patients Aged 2 to <18 Years with Uncontrolled Atopic Dermatitis: A Single‐Center, Real‐World Study

Dupilumab in daily practice for the treatment of pediatric atopic dermatitis: 28‐week clinical and biomarker results from the BioDay registry

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