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Abstract
Atopic dermatitis (AD) is the most common inflammatory skin disease in children. Children with severe AD have a multidimensional disease burden characterized by skin lesions, itching, frequent infections, sleep deprivation, and a high rate of comorbidities. These impact the mental health and overall quality of life of not only the children but also of their parents and caregivers. There are few effective available treatment options for young children with severe AD that are suitable for long-term use. Due to their adverse effects, practice guidelines consider systemic agents inappropriate for this age group, although they are still used off-label in extreme cases. The biologic dupilumab has recently been approved for children aged 6–11 years with severe (EU) and moderate-to-severe (USA) AD, offering hope to this population of patients with a high unmet clinical need. The purpose of this review is to describe the unmet needs of AD patients aged 6–11 years prior to dupilumab approval and to summarize existing clinical data supporting dupilumab’s safety and efficacy in these children.
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Abbreviations
AD, atopic dermatitis; AR, allergic rhinitis; BSA, body surface area; CDLQI, Children’s Dermatology Life Quality Index; CI, confidence interval; DFI, dermatitis family impact; EASI, Eczema Area and Severity Index; EASI-50/75/90, ≥50%/75%/90% improvement from baseline in EASI; HLT, MedDRA High-Level Term; IGA, Investigator’s Global Assessment; JAK, Janus kinase; MedDRA, Medical Dictionary for Regulatory Activities; N/A, not available; NRS, Numerical Rating Scale; NSISS, systemic non-steroidal immunosuppressants; OLE, open-label extension; OR, odds rate; POEM, Patient-Oriented Eczema Measure; PP-NRS, Peak Pruritus Numerical Rating Scale; PT, MedDRA Preferred Term; q2w, every 2 weeks; q4w, every 4 weeks; qw, weekly; SCORAD, SCORing Atopic Dermatitis; SD, standard deviation; SE, standard error; SOC, MedDRA System Organ Class; TCS, topical corticosteroids; TEAE, treatment-emergent adverse event; VAS, Visual Analog Scale.
Data Sharing Statement
No original data are reported in this article.
Acknowledgments
ClinicalTrials.gov Identifiers: NCT02407756, NCT03346434, NCT02612454, NCT03054428, NCT03345914. The study sponsors participated in the writing of the report and the decision to submit the article for publication. Medical writing/editorial assistance was provided by Lola MacRae, PhD, and Carolyn Ellenberger, PhD, of Excerpta Medica, and was funded by Sanofi and Regeneron Pharmaceuticals Inc., according to the Good Publication Practice guidelines. Spider gram and rainbow graphics were developed by Ana B. Rossi and Marthe Vuillet of Sanofi.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising, or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
Professor Michael J Cork has served as a consultant and/or advisory board member and/or received research grants from Almirall, Amgen, Astellas Pharma, Bayer, GSK, Hyphens Pharma, Johnson & Johnson, LEO Pharma, L’Oréal, Novartis, Perrigo, Pfizer, Procter & Gamble, Sanofi, Stiefel, Regeneron Pharmaceuticals Inc., and Unilever. Professor Michael J Cork is a voluntary medical advisor to the National Eczema Society UK.
Dr Simon G Danby reports grants from Sanofi, Almirall, Johnson & Johnson, and Leo Pharma; grants, personal fees from Perrigo, Pfizer, and Hyphens Pharma, outside the submitted work.
Dr Ana B. Rossi is an employee of and may hold stock and/or stock options in Sanofi.
Dr Ashish Bansal is an employee and shareholder of Regeneron Pharmaceuticals Inc.