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Ongoing research, in particular case-controlled studies, supports the safety of using topical calcineurin inhibitors (TCIs), particular as long-term intermittent therapy for either mild to moderate or moderate to severe atopic dermatitis.
In an interview with Dermatology Times, Lawrence Eichenfield, M.D., professor of pediatrics and dermatology, University of California, chief of pediatric dermatology at Rady Children's Hospital, says that while fewer nondermatologists, such as pediatricians, are turning to TCIs as a treatment for atopic dermatitis, dermatologists continue to utilize the medications.
"Those (physicians) who have continued to prescribe it have been reassured by personal experience, as well as continuing literature that involves case-controlled studies," Dr. Eichenfield says, noting that independent groups have conducted the case-controlled studies.
The change in prescribing patterns with regard to topical calcineurin inhibitors - such as tacrolimus (Protopic, Astellas Pharma) and pimecrolimus (Elidel, Novartis) - have been adversely affected since the Food and Drug Administration (FDA) issued a "black box" warning in February 2005 advising against long-term use of TCIs in the treatment of atopic dermatitis.
The original indication for both the calcineurin inhibitors had been that they should not be prescribed in children age 2 and younger, because the agents have not been well-studied in this population. That warning was issued after reports of 29 cases of malignancies, mainly skin cancers and cutaneous lymphomas.
The calcineurin inhibitors are considered second-line therapy after topical corticosteroids for the treatment of atopic dermatitis. Systemic corticosteroids, either oral or injected, and other potent immunosuppressive agents are used in cases in which the atopic dermatitis is severe and refractory to therapy with topical corticosteroids.
Another treatment choice for severe eczema that is refractory to topical steroids is phototherapy.
Dr. Eichenfield says the calcineurin inhibitors have a place in the treatment armamentarium. When acute eczema occurs in sensitive areas of the skin or "hot spots," or there is rapid reoccurrence of eczema when topical corticosteroids are not used regularly, calcineurin inhibitors are a solid therapeutic choice.
Moreover, calcineurin inhibitors represent an alternative to corticosteroids for treating the inflammatory component of atopic dermatitis. Therapy for atopic dermatitis requires a multifaceted approach.
While corticosteroids and calcineurin inhibitors address the inflammatory component of the condition, patients should avoid specific triggers and irritants, and should address the repair and maintenance of the stratum corneum, as well as the itch-scratch cycle.
Moreover, there is recognition that continual use of corticosteroids over time should be curbed, for fear of long-term adverse events.
A study published in Dermatology in 2007 found that the use of Elidel 1% resulted in less use of steroids on the head and neck among children with severe atopic dermatitis, suggesting its role in long-term therapy. The patient may express concerns about the side effects associated with steroids, and in the pediatric setting, the patient's family may express concerns.
"It's very common to choose calcineurin inhibitors as maintenance therapy," Dr. Eichenfield says.
"We now regularly utilize TCIs in certain types of patients, regardless of the age of the patient," he says.
"A long-term intermittent application treatment strategy with TCIs is highly useful, and there is an increasing data set to show their safety and utility in patients who cannot otherwise be maintained disease-free with steroids alone," Dr. Eichenfield says.
In his own practice, especially with child and adolescent patients, the majority of parents report that their child's eczema is persistent, and many are unable to remember if or when the skin was totally clear without aggressive therapy, suggesting that therapy during remission periods is warranted.
The calcineurin inhibitors are not being prescribed solely for atopic dermatitis. Calcineurin inhibitors are finding off-label use in the therapy for other dermatological conditions such as lichen sclerosis, vitiligo, psoriasis and other inflammatory conditions.
Although the calcineurin inhibitors are not indicated in children age 2 and younger, Dr. Eichenfield says there is a robust data set to support use of the agents in very young children, when warranted by disease severity.