The Pharmaceutical Journal
Vol 270 No 7250 p710
24 May 2003

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Drug and Therapeutics Bulletin (more)

Evidence for pimecrolimus questioned and advertisement criticised by DTB

No convincing evidence exists to justify the use of pimecrolimus (Elidel) cream in first-line management of atopic dermatitis, according to the Drug and Therapeutics Bulletin. Furthermore, the bulletin criticises an advertisement for the cream. Novartis, manufacturer of Elidel, withdrew the advertisement before the bulletin was published.

This month's DTB questions the efficacy of pimecrolimus as an alternative to conventional therapy with corticosteroid creams. It reviewed evidence that examined the use of pimecrolimus in both treatment of dermatitis and prevention of flares. Although studies showed that pimecrolimus was more effective than a placebo cream, the bulletin found no trials that compared it with standard therapy.

"Long-term intermittent use of pimecrolimus cream to prevent progression from early symptoms of atopic dermatitis to flares has not been compared with the most appropriate conventional therapy for patients with mild or moderate disease, that is, brief treatment with a mild or moderately potent corticosteroid commencing before the flare has become severe," the bulletin concludes.

The same is true for treatment of dermatitis in children where no trial compared pimecrolimus with mild or moderately potent steroid creams. In adults, a trial comparing pimecrolimus with 0.1 per cent betamethasone found that the steroid cream was more effective for dermatitis.

The bulletin also criticises an advertisement for pimecrolimus cream. The cream is licensed for children aged over two years, but the advertisement shows a picture of a baby who appeared to be younger than this. "This implies its use in this age group and therefore breaches [advertising] regulations," it says (2003;41:33).

However, a spokesman for Novartis said that the child was aged over two years when the photograph was taken but, following feedback from the Medicines and health Products Regulatory Agency, the company withdrew the advertisement. Corrective statements will appear in all publications in which the advertisement appeared.

In terms of the DTB's other conclusions, he said: "Studies were designed to evaluate the efficacy of pimecrolimus in the prevention of flares of atopic eczema. As there are no other treatments that are specifically licensed for this indication, no studies were undertaken with an active comparator."