Unmet medical needs in the treatment of atopic dermatitis in infants: An
Expert consensus on safety and efficacy of pimecrolimus
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concerns are no longer valid.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.