Dupilumab Provides Rapid and Sustained Improvement in SCORing Atopic Dermatitis Outcomes in Paediatric Patients with Atopic Dermatitis
DOI:
https://doi.org/10.2340/actadv.v102.854Keywords:
atopic dermatitis, SCORAD, dupilumab, pediatricsAbstract
This post hoc analysis examined SCORing Atopic Dermatitis (SCORAD) outcomes in 471 paediatric patients (children age 6–<12 years, n = 304; adolescents age 12–<18 years, n = 167) with atopic dermatitis treated with dupilumab, ± topical corticosteroids, in two 16-week phase 3 randomized controlled trials and a 1-year interim data cut of a subsequent open-label extension study. Paediatric patients treated with dupilumab (± topical corticosteroids) had significantly lower SCORAD, objective SCORAD (o-SCORAD), and individual SCORAD components from week 3 to 16 compared with placebo (± topical corticosteroids) in the randomized controlled trials. The results were sustained or continuously improved over 1 year of open-label treatment with dupilumab ± topical corticosteroids. SCORAD-50 was achieved in almost all patients (91.3–91.8%) by week 52 with continued dupilumab treatment across age groups. Almost all (> 86%) patients achieved mild or absent pruritus and sleep loss at week 52. In conclusion, dupilumab ± topical corticosteroids resulted in rapid and significant improvements in all aspects of SCORAD analysed, and the results were sustained over 1 year.
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References
Silverberg JI, Barbarot S, Gadkari A, Simpson EL, Weidinger S, Mina-Osorio P, et al. Atopic dermatitis in the pediatric population: a cross-sectional, international, epidemiologic study. Ann Allergy Asthma Immunol 2021; 126: 417-428.e2.
https://doi.org/10.1016/j.anai.2020.12.020
Bylund S, Kobyletzki LB, Svalstedt M, Svensson Å. Prevalence and incidence of atopic dermatitis: a systematic review. Acta Derm Venereol 2020; 100: adv00160.
https://doi.org/10.2340/00015555-3510 DOI: https://doi.org/10.2340/00015555-3510
Slattery MJ, Essex MJ, Paletz EM, Vanness ER, Infante M, Rogers GM, et al. Depression, anxiety, and dermatologic quality of life in adolescents with atopic dermatitis. J Allergy Clin Immunol 2011; 128: 668-671.
https://doi.org/10.1016/j.jaci.2011.05.003 DOI: https://doi.org/10.1016/j.jaci.2011.05.003
Yang EJ, Beck KM, Sekhon S, Bhutani T, Koo J. The impact of pediatric atopic dermatitis on families: a review. Pediatr Dermatol 2019; 36: 66-71.
https://doi.org/10.1111/pde.13727 DOI: https://doi.org/10.1111/pde.13727
Silverberg JI, Barbarot S, Gadkari A, Simpson EL, Weidinger S, Mina-Osorio P, et al. Atopic dermatitis in the pediatric population: a cross-sectional, international epidemiologic study. Ann Allergy Asthma Immunol 2021; 126: 417-28.e2.
https://doi.org/10.1016/j.anai.2020.12.020 DOI: https://doi.org/10.1016/j.anai.2020.12.020
Gilaberte Y, Pérez-Gilaberte JB, Poblador-Plou B, Bliek-Bueno K, Gimeno-Miguel A, Prados-Torres A. Prevalence and comorbidity of atopic dermatitis in children: a large-scale population study based on real-world data. J Clin Med 2020; 9: 1632.
https://doi.org/10.3390/jcm9061632 DOI: https://doi.org/10.3390/jcm9061632
Huang AH, Roh YS, Sutaria N, Choi J, Williams KA, Canner JK, et al. Real-world comorbidities of atopic dermatitis in the pediatric ambulatory population in the United States. J Am Acad Dermatol 2021; 85: 893-900.
https://doi.org/10.1016/j.jaad.2021.03.016 DOI: https://doi.org/10.1016/j.jaad.2021.03.016
Wollenberg A, Barbarot S, Bieber T, Christen-Zaech S, Deleuran M, Fink-Wagner A, et al. Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I. J Eur Acad Dermatol Venereol 2018; 32: 657-682.
https://doi.org/10.1111/jdv.14891 DOI: https://doi.org/10.1111/jdv.14891
Wollenberg A, Barbarot S, Bieber T, Christen-Zaech S, Deleuran M, Fink-Wagner A, et al. Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part II. J Eur Acad Dermatol Venereol 2018; 32: 850-878.
https://doi.org/10.1111/jdv.14888 DOI: https://doi.org/10.1111/jdv.14888
Eichenfield LF, Tom WL, Chamlin SL, Feldman SR, Hanifin JM, Simpson EL, et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol 2014; 70: 338-351.
https://doi.org/10.1016/j.jaad.2013.10.010 DOI: https://doi.org/10.1016/j.jaad.2013.10.010
Chopra R, Vakharia PP, Sacotte R, Patel N, Immaneni S, White T, et al. Severity strata for Eczema Area and Severity Index (EASI), modified EASI, Scoring Atopic Dermatitis (SCORAD), objective SCORAD, Atopic Dermatitis Severity Index and body surface area in adolescents and adults with atopic dermatitis. Br J Dermatol 2017; 177: 1316-1321.
https://doi.org/10.1111/bjd.15641 DOI: https://doi.org/10.1111/bjd.15641
Silverberg JI, Lei D, Yousaf M, Janmohamed SR, Vakharia PP, Chopra R, et al. What are the best endpoints for Eczema Area and Severity Index and Scoring Atopic Dermatitis in clinical practice? A prospective observational study. Br J Dermatol 2021; 184: 888-895.
https://doi.org/10.1111/bjd.19457 DOI: https://doi.org/10.1111/bjd.19457
Wollenberg A, Oranje A, Deleuran M, Simon D, Szalai Z, Kunz B, et al. ETFAD/EADV Eczema task force 2015 position paper on diagnosis and treatment of atopic dermatitis in adult and paediatric patients. J Eur Acad Dermatol Venereol 2016; 30: 729-747.
https://doi.org/10.1111/jdv.13599 DOI: https://doi.org/10.1111/jdv.13599
Wollenberg A, Christen-Zäch S, Taieb A, Paul C, Thyssen JP, de Bruin-Weller M, et al. ETFAD/EADV Eczema task force 2020 position paper on diagnosis and treatment of atopic dermatitis in adults and children. J Eur Acad Dermatol Venereol 2020; 34: 2717-2744.
https://doi.org/10.1111/jdv.16892 DOI: https://doi.org/10.1111/jdv.16892
Paller AS, Siegfried EC, Thaçi D, Wollenberg A, Cork MJ, Arkwright PD, et al. 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. J Am Acad Dermatol 2020; 83: 1282-1293.
https://doi.org/10.1016/j.jaad.2020.06.054 DOI: https://doi.org/10.1016/j.jaad.2020.06.054
Cork MJ, Thaçi D, Eichenfield LF, Arkwright PD, Hultsch T, Davis JD, et al. Dupilumab in adolescents with uncontrolled moderate-to-severe atopic dermatitis: results from a phase IIa open-label trial and subsequent phase III open-label extension. Br J Dermatol 2020; 182: 85-96.
https://doi.org/10.1111/bjd.18476 DOI: https://doi.org/10.1111/bjd.18476
Simpson EL, Paller AS, Siegfried EC, Boguniewicz M, Sher L, Gooderham MJ, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial. JAMA Dermatol 2020; 156: 44-56.
https://doi.org/10.1001/jamadermatol.2019.3336 DOI: https://doi.org/10.1001/jamadermatol.2019.3336
Battisti WP, Wager E, Baltzer L, Bridges D, Cairns A, Carswell CI, et al. Good publication practice for communicating company-sponsored medical research: GPP3. Ann Intern Med 2015; 163: 461-464.
https://doi.org/10.7326/M15-0288 DOI: https://doi.org/10.7326/M15-0288
Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology 1993; 186: 23-31.
https://doi.org/10.1159/000247298 DOI: https://doi.org/10.1159/000247298
McKenzie C, Paller AS, Fishbein A, Silverberg JI. Association between the longitudinal course of AD, sleep disturbance, and overall health in US children. J Allergy Clin Immunol Pract 2020; 8: 812-814.e1.
https://doi.org/10.1016/j.jaip.2019.08.027 DOI: https://doi.org/10.1016/j.jaip.2019.08.027
Silverberg JI, Garg NK, Paller AS, Fishbein AB, Zee PC. Sleep disturbances in adults with eczema are associated with impaired overall health: a US population-based study. J Invest Dermatol 2015; 135: 56-66.
https://doi.org/10.1038/jid.2014.325 DOI: https://doi.org/10.1038/jid.2014.325
Fishbein AB, Cheng BT, Tilley CC, Begolka WS, Carle AC, Forrest CB, et al. Sleep disturbance in school-aged children with atopic dermatitis: prevalence and severity in a cross-sectional sample. J Allergy Clin Immunol Pract 2021; 9: 3120-3129.e3.
https://doi.org/10.1016/j.jaip.2021.04.064 DOI: https://doi.org/10.1016/j.jaip.2021.04.064
Fishbein AB, Mueller K, Kruse L, Boor P, Sheldon S, Zee P, et al. Sleep disturbance in children with moderate/severe atopic dermatitis: a case-control study. J Am Acad Dermatol 2018; 78: 336-341.
https://doi.org/10.1016/j.jaad.2017.08.043 DOI: https://doi.org/10.1016/j.jaad.2017.08.043
Schmitt J, Spuls PI, Thomas KS, Simpson E, Furue M, Deckert S, et al. The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials. J Allergy Clin Immunol 2014; 134: 800-807.
https://doi.org/10.1016/j.jaci.2014.07.043 DOI: https://doi.org/10.1016/j.jaci.2014.07.043
Vakharia PP, Chopra R, Sacotte R, Patel N, Immaneni S, White T, et al. Severity strata for five patient-reported outcomes in adults with atopic dermatitis. Br J Dermatol 2018; 178: 925-930.
https://doi.org/10.1111/bjd.16078 DOI: https://doi.org/10.1111/bjd.16078
Kunz B, Oranje AP, Labrèze L, Stalder JF, Ring J, Taïeb A. Clinical validation and guidelines for the SCORAD index: consensus report of the European Task Force on Atopic Dermatitis. Dermatology 1997; 195: 10-19.
https://doi.org/10.1159/000245677 DOI: https://doi.org/10.1159/000245677
Stalder JF, Barbarot S, Wollenberg A, Holm EA, De Raeve L, Seidenari S, et al. Patient-Oriented SCORAD (PO-SCORAD): a new self-assessment scale in atopic dermatitis validated in Europe. Allergy 2011; 66: 1114-1121.
https://doi.org/10.1111/j.1398-9995.2011.02577.x DOI: https://doi.org/10.1111/j.1398-9995.2011.02577.x
Brandt EB, Sivaprasad U. Th2 cytokines and atopic dermatitis. J Clin Cell Immunol 2011; 2: 110.
Kolb L, Ferrer-Bruker S. Atopic dermatitis. StatPearls (Internet) 2021 Available from: https://www.ncbi.nlm.nih.gov/books/NBK448071/.
Beck LA, Thaçi D, Hamilton JD, Graham NM, Bieber T, Rocklin R, et al. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med 2014; 371: 130-139.
https://doi.org/10.1056/NEJMoa1314768 DOI: https://doi.org/10.1056/NEJMoa1314768
Hamilton JD, Suárez-Fariñas M, Dhingra N, Cardinale I, Li X, Kostic A, et al. Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol 2014; 134: 1293-1300.
https://doi.org/10.1016/j.jaci.2014.10.013 DOI: https://doi.org/10.1016/j.jaci.2014.10.013
Guttman-Yassky E, Bissonnette R, Ungar B, Suárez-Fariñas M, Ardeleanu M, Esaki H, et al. Dupilumab progressively improves systemic and cutaneous abnormalities in patients with atopic dermatitis. J Allergy Clin Immunol 2019; 143: 155-172.
https://doi.org/10.1016/j.jaci.2018.08.022 DOI: https://doi.org/10.1016/j.jaci.2018.08.022
Rohner MH, Thormann K, Cazzaniga S, Yousefi S, Simon HU, Schlapbach C, et al. Dupilumab reduces inflammation and restores the skin barrier in patients with atopic dermatitis. Allergy 2021; 76: 1268-1270.
https://doi.org/10.1111/all.14664 DOI: https://doi.org/10.1111/all.14664
Berdyshev E, Goleva E, Bissonnette R, Bronova I, Bronoff AS, Richers B, et al. Dupilumab treatment significantly improves skin barrier function in adult and adolescent patients with moderate to severe atopic dermatitis. J All Clin Immunol 2022; 149: AB10.
https://doi.org/10.1016/j.jaci.2021.12.073 DOI: https://doi.org/10.1016/j.jaci.2021.12.073
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Copyright (c) 2022 Andreas Wollenberg, Danielle Marcoux, Jonathan Silverberg, Valeria Aoki, Eulalia Baselga, Haixin Zhang, Noah A. Levit, Alain Taieb, Ana B. Rossi
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