General Information

Elidel (pimecrolimus) is a topical calcineurin inhibitor.

Elidel is specifically indicated as a second-line therapy for short term and intermittent long-term therapy of mild to moderate atopic dermatitis in non-immunocompromised patients 3 months of age and older, in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies.  

This topical cream should be applied twice-daily. Therapy should be stopped upon clearance of the signs and symptoms of atopic dermatitis. Treatment should be discontinued if resolution of disease occurs. If no improvement occurs after 3 weeks of treatment, or in case of disease exacerbation, therapy should be discontinued, and patients should consult their physicians.

Mechanism of Action

The exact mechanism of action of pimecrolimus in atopic dermatitis is not known. However, it has been demonstrated that pimecrolimus binds with high affinity to macrophilin-12 and inhibits the calcium-dependent phosphatase, calcineurin. As a consequence, it inhibits T cell activation by blocking the transcription of early cytokines. In particular, pimecrolimus inhibits at nanomolar concentrations Interleukin-2 and interferon gamma (Th1-type) and Interleukin-4 and Interleukin10 (Th2-type) cytokine synthesis in human T cells. In addition, pimecrolimus prevents the release of cytokines and pro-inflammatory mediators from mast cells in vitro after stimulation by antigen/IgE. Pimecrolimus does not affect the growth of, or IL-8 release from, keratinocyte, fibroblast, and endothelial cell lines.

Side Effects

Adverse events associated with the use of Elidel may include (but are not limited to) the following:

• Application site burning
• Headache
• Cold-like symptoms

Clinical Trial Results

The approval of Elidel is based on results from clinical trials in more than 1,700 pediatric and adult patients. Elidel was shown to relieve itching and redness associated with eczema within eight days of starting treatment.