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      The Application of Dupilumab to Pediatric Patients Aged 6–11yrs with Moderate-to-Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled: The Clinical Data so Far


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          While dupilumab has shown efficacy in improving atopic dermatitis, few studies have assessed the long-term clinical data of dupilumab use in pediatric patients.


          In the present study, we reviewed the current literature to assess reported efficacies, side effects, and risks of using dupilumab to treat atopic dermatitis in pediatric populations.


          Using PRISMA guidelines, the authors searched PubMed/MEDLINE and Embase for studies related to dupilumab treatment for atopic dermatitis in pediatric patients aged 6–11 years old.


          A total of 512 pediatric patients (ages 6–11) were included. Outcome measures assessed by EASI, SCORAD, P-NRS, IGA and C-DLQI showed significant improvements in scores from those observed at baseline to the last treatment of dupilumab. Most reported adverse effects on dupilumab were conjunctivitis and infection site reactions. All studies reported that dupilumab was well-tolerated.


          Limitations include the low number of studies available and observation periods of up to 16 weeks, which may be too short to evaluate the drug’s effectiveness and occurrence of adverse effects. This also limits our knowledge on whether there are sustained benefits and/or diminished efficacy as well as long-term side effects.


          Thus far, the data demonstrates dupilumab to be safe and effective in the management of moderate-to-severe atopic dermatitis in children aged 6–11 years. Future studies should evaluate long-term dupilumab use and sustained effects.

          Most cited references15

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          Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies.

          Atopic dermatitis is a common and chronic, pruritic inflammatory skin condition that can affect all age groups. This evidence-based guideline addresses important clinical questions that arise in its management. In this second of 4 sections, treatment of atopic dermatitis with nonpharmacologic interventions and pharmacologic topical therapies are reviewed. Where possible, suggestions on dosing and monitoring are given based on available evidence.
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            Efficacy and Safety of Dupilumab in Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis : A Phase 3 Randomized Clinical Trial

            Question What is the efficacy and safety of dupilumab monotherapy in adolescents with moderate to severe inadequately controlled atopic dermatitis? Findings In this randomized phase 3 clinical trial including 251 adolescents with moderate to severe atopic dermatitis, dupilumab 200 or 300 mg every 2 weeks and 300 mg every 4 weeks resulted in a significant treatment response vs placebo following 16-week treatment, with an acceptable safety profile. Meaning The findings appear to support the use of dupilumab for the treatment of adolescents with moderate to severe atopic dermatitis. Importance Adolescents with atopic dermatitis (AD) have high disease burden negatively affecting quality of life, with limited treatment options. The efficacy and safety of dupilumab, a monoclonal antibody, approved for treatment in adolescent patients with inadequately controlled AD, remain unknown in this patient population. Objective To assess the efficacy and safety of dupilumab monotherapy in adolescents with moderate to severe inadequately controlled AD. Design, Setting, and Participants A randomized, double-blind, parallel-group, phase 3 clinical trial was conducted at 45 US and Canadian centers between March 21, 2017, and June 5, 2018. A total of 251 adolescents with moderate to severe AD inadequately controlled by topical medications or for whom topical therapy was inadvisable were included. Interventions Patients were randomized (1:1:1; interactive-response system; stratified by severity and body weight) to 16-week treatment with dupilumab, 200 mg (n = 43; baseline weight <60 kg), or dupilumab, 300 mg (n = 39; baseline weight ≥60 kg), every 2 weeks; dupilumab, 300 mg, every 4 weeks (n = 84); or placebo (n = 85). Main Outcomes and Measures Proportion of patients with 75% or more improvement from baseline in Eczema Area and Severity Index (EASI-75) (scores range from 0 to 72, with higher scores indicating greater severity) and Investigator’s Global Assessment (IGA) 0 or 1 on a 5-point scale (scores range from 0 to 4, with higher scores indicating greater severity) at week 16. Results A total of 251 patients were randomized (mean [SD] age, 14.5 [1.7] years; 148 [59.0%] male). Of 250 patients with data available on concurrent allergic conditions, most had comorbid type 2 diseases (asthma, 134 [53.6%]; food allergies, 60.8%; allergic rhinitis, 65.6%). A total of 240 patients (95.6%) completed the study. Dupilumab achieved both coprimary end points at week 16. The proportion of patients with EASI-75 improvement from baseline increased (every 2 weeks, 41.5%; every 4 weeks, 38.1%; placebo, 8.2%) with differences vs placebo of 33.2% (95% CI, 21.1%-45.4%) for every 2 weeks and 29.9% (95% CI, 17.9%-41.8%) for every 4 weeks ( P  < .001). Efficacy of the every-2-week regimen was generally superior to the every-4-week regimen. Patients in the dupilumab arms had higher percentage values of conjunctivitis (every 2 weeks, 9.8%; every 4 weeks, 10.8%; placebo, 4.7%) and injection-site reactions (every 2 weeks, 8.5%; every 4 weeks, 6.0%; placebo, 3.5%), and lower nonherpetic skin infections (every 2 weeks, 9.8%; every 4 weeks, 9.6%; placebo, 18.8%). Conclusions and Relevance In this study, dupilumab significantly improved AD signs, symptoms, and quality of life in adolescents with moderate to severe AD, with an acceptable safety profile. Placebo-corrected efficacy and safety of dupilumab were similar in adolescents and adults. Trial Registration ClinicalTrials.gov identifier: NCT03054428 This phase 3 randomized clinical trial evaluates the efficacy and safety of 2 dose regimens of dupilumab for treatment of moderate to severe atopic dermatitis in adolescents.
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              Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: A randomized, double-blinded, placebo-controlled phase 3 trial.

              Children with severe atopic dermatitis (AD) have limited treatment options.

                Author and article information

                Drug Des Devel Ther
                Drug Des Devel Ther
                Drug Design, Development and Therapy
                01 May 2023
                : 17
                : 1323-1327
                [1 ]School of Medicine, New York Medical College , Valhalla, NY, USA
                [2 ]Department of Dermatology, New York Medical College , Valhalla, NY, USA
                [3 ]Department of Dermatology, Metropolitan Medical Center , New York, NY, USA
                [4 ]Department of Dermatology, Lincoln Medical Center , Bronx, NY, USA
                Author notes
                Correspondence: Abigail Cline, Email Aecline25@gmail.com
                © 2023 Balboul et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                : 01 March 2023
                : 21 April 2023
                Page count
                Figures: 0, Tables: 1, References: 15, Pages: 5
                Funded by: no funding to;
                There is no funding to report.

                Pharmacology & Pharmaceutical medicine
                pediatric,pediatric dermatology,atopic dermatitis,dupilumab


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