The Pharmaceutical Journal
Vol 274 No 7339 p263
5 March 2005

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Evidence is lacking for newer eczema treatments

Data on the comparative use of eczema treatments is lacking, making it hard for clinicians to judge when use of newer treatments would be appropriate, UK researchers say.

Darren Ashcroft, of the University of Manchester’s school of pharmacy and pharmaceutical sciences, and colleagues examined data from 25 clinical trials of pimecrolimus (Elidel) and tacrolimus (Protopic).

Their review revealed that pimecrolimus is less effective than betamethasone valerate 0.1 per cent and found no evidence that pimecrolimus is any more effective than less potent topical corticosteroids. “In practice, pimecrolimus is being aimed at patients with mild atopic dermatitis, yet this is being done in the absence of randomised controlled trials that compare it with existing therapy for such a group — that is, short bursts of 1 per cent hydrocortisone to treat acute flares.”

There was more evidence to support use of tacrolimus 0.1 per cent, which was found to be as effective as potent topical corticosteroids and more effective than mild topical corticosteroids. “This means that topical tacrolimus may be useful for resistant atopic dermatitis at sensitive sites such as the face,” they say, adding that this drug may also be useful for patients who depend on constant use of potent steroids.

The researchers point out that one of the reasons for developing new drugs as alternatives to topical steroids was to overcome possible side effects such as thinning of the skin and adrenal gland suppression. However, they say they found no clear evidence that pimecrolimus or tacrolimus offer such an advantage when compared with standard practice.

“The lack of key comparative data highlights deficiencies in the current licensing systems for medicines in Europe and the US, which require only evidence of efficacy and safety above placebo and vehicle, thus allowing more new drugs to reach the market.” This, say the researchers, leaves prescribers and the public confused about how and when to use such new drugs.

They suggest that pragmatic randomised trials lasting at least 12 months are needed to compare tacrolimus, pimecrolimus and 1 per cent hydrocortisone acetate.

A spokeswoman for Novartis, manufacturer of Elidel, pointed out that the National Institute for Clinical Excellence recommends pimecrolimus as an option for second-line treatment of moderate atopic eczema on the face and neck in children aged two to 16 years.

The study was published on BMJ Online First on 24 February.