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Unmet medical needs in the treatment of atopic dermatitis in infants: An Expert consensus on safety and efficacy of pimecrolimus
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  • Thomas Luger,
  • Matthias Augustin,
  • Julien Lambert,
  • Carle Paul,
  • Carlo Pincelli,
  • Antonio Torrelo,
  • Christian Vestergaard,
  • Ulrich Wahn,
  • Thomas Werfel
Thomas Luger
University Hospital Munster
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Matthias Augustin
University Medical Center Hamburg-Eppendorf
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Julien Lambert
UZA
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Carle Paul
Toulouse University Hospital
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Carlo Pincelli
University of Modena and Reggio Emilia
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Antonio Torrelo
Hospital Niño Jesus
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Christian Vestergaard
Aarhus University Hospital
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Ulrich Wahn
Charité
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Thomas Werfel
Hannover Medical School
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Abstract

Atopic dermatitis (AD) is a common skin disease during infancy, which imposes a considerable burden on patients, their families, and the society, requiring effective treatment options that result in rapid and sustained symptom relief. Additionally, early treatment may prevent the development of atopic comorbidities by restoring the skin barrier. Currently, topical standard-of-care for AD in infants includes emollients and topical corticosteroids (TCS) to treat and reduce the risk of flares. However, only few have been approved for infants and long-term maintenance therapy with TCS is not indicated due to potential local and systemic side effects, including skin atrophy. Accordingly, the recently updated European guidelines for treatment of AD recommend topical calcineurin inhibitors (TCIs) for long-term use, treatment of sensitive skin areas, and for use in the pediatric population. Evidence on the use of TCIs for infants has almost been exclusively collected for pimecrolimus, with >4,000 infants evaluated in clinical trials, consistently confirming that pimecrolimus is a safe and effective treatment for infants with AD. Nevertheless, its use is still restricted in most countries to children above the age of 2 years due to initial and mostly theoretical safety concerns. Based on a careful review of the available evidence of clinical trials, post-marketing surveillance, and epidemiological studies, an Expert Panel of European dermatologists and pediatric allergologists concluded that these safety concerns are no longer valid. Therefore, pimecrolimus offers a safe and effective alternative to TCS in infants aged 3 months and above, and labeling restrictions in this age group are no longer justified.

Peer review status:Published

03 Sep 2020Submitted to Pediatric Allergy and Immunology
09 Sep 2020Reviewer(s) Assigned
07 Oct 2020Review(s) Completed, Editorial Evaluation Pending
12 Oct 2020Editorial Decision: Revise Minor
22 Oct 20201st Revision Received
22 Oct 2020Review(s) Completed, Editorial Evaluation Pending
23 Oct 2020Reviewer(s) Assigned
18 Nov 2020Editorial Decision: Accept
Apr 2021Published in Pediatric Allergy and Immunology volume 32 issue 3 on pages 414-424. 10.1111/pai.13422