Unmet medical needs in the treatment of atopic dermatitis in infants: An Expert consensus on safety and efficacy of pimecrolimus

Autor: Carle Paul, Ulrich Wahn, Thomas Werfel, Julien Lambert, Christian Vestergaard, Matthias Augustin, Antonio Torrelo, Thomas A. Luger, Carlo Pincelli
Rok vydání: 2020
Předmět:
safety
medicine.medical_specialty
Consensus
Immunology
efficacy
Tacrolimus/adverse effects
Calcineurin Inhibitors
CHILDREN
ECZEMA
Disease
Calcineurin Inhibitors/adverse effects
Tacrolimus
Sensitive skin
Dermatitis
Atopic
03 medical and health sciences
Pimecrolimus
0302 clinical medicine
Maintenance therapy
QUALITY-OF-LIFE
Epidemiology
medicine
Immunology and Allergy
Dermatitis
Atopic/drug therapy
Humans
030212 general & internal medicine
Intensive care medicine
Child
RISK
atopic dermatitis
BIRTH COHORT
business.industry
Infant
Newborn
Infant
Atopic dermatitis
TOPICAL CALCINEURIN INHIBITORS
medicine.disease
pimecrolimus
SYSTEMIC EXPOSURE
CREAM 1-PERCENT
Calcineurin
Clinical trial
TACROLIMUS OINTMENT
Treatment Outcome
030228 respiratory system
Pediatrics
Perinatology and Child Health
TOLERABILITY
Human medicine
business
medicine.drug
Zdroj: Luger, T, Augustin, M, Lambert, J, Paul, C, Pincelli, C, Torrelo, A, Vestergaard, C, Wahn, U & Werfel, T 2021, ' Unmet medical needs in the treatment of atopic dermatitis in infants : An Expert consensus on safety and efficacy of pimecrolimus ', Pediatric Allergy and Immunology, vol. 32, no. 3, pp. 414-424 . https://doi.org/10.1111/pai.13422
Pediatric allergy and immunology
ISSN: 1399-3038
0905-6157
DOI: 10.1111/pai.13422
Popis: 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 >4000 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.
Databáze: OpenAIRE
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