Elidel® (Pimecrolimus) - Detailing from Skin Therapy Letter

 

Elidel® (Pimecrolimus)

 

 

  Content:

CLINICAL EXPERIENCE

 

 

  • Extensive clinical experience exists with the use of Elidel cream in over 5 million patients with atopic dermatitis (including over 19,000 patients in clinical trials)
  • Of the 19,000 patients in clinical trials, 14% were infants (3 to 23 months), 38% were children (2-17 years) and 48% were adults.
  • Data indicate that the average patient treats for an average of 45 days over the course of a year and uses 72 g/ year
  • Published trials have looked at the short term and intermittent long term use (up to 2 years) of Elidel in atopic dermatitis

Clinical trials

  • Most clinical trials with Elidel have been done in patients with mild to moderate atopic dermatitis.
  • Many trials with Elidel have a similar design. Elidel or placebo cream is applied BID at first signs/symptoms of atopic dermatitis (itch/redness) to prevent progression to flares.In the event of flares, a moderately potent corticosteroid is permitted as rescue medication. The percentage of patients without flares (e.g. without the need to use corticosteroids as a rescue) in patients treated with Elidel versus placebo cream is compared.
  • This design of clinical trials is reflecting the practical use of the drug in the clinic.

Adults with AD


Children with AD


Infants with AD


Onset of action

Conclusion

  • Elidel cream is a new treatment option for the intermittent long term control of eczema, acting as a flare prevention agent.
  • Elidel does not induce skin atrophy.
  • Elidel has been shown to be safe according to available clinical data.
  • The only significant immediate side effect is a sensation of warmth at site of application, occurring in < 10 % of patients (12 % for the placebo groups).
  • Long term safety data are limited to more than 8 years. There is no trend that would suggest toxicity or tachyphylaxis on the long term.

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