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Tacrolimus and Pimecrolimus: Are They Better Than Steroids?

Topical immunomodulators remain important alternatives for managing atopic dermatitis.

Since the launch of the topical immunomodulators tacrolimus and pimecrolimus, these agents have been used increasingly by dermatologists and other clinicians. A growing body of literature supports the efficacy of these drugs in treating atopic dermatitis, but data on how they compare with topical steroid treatment are still emerging. In this meta-analysis, British investigators examined data from 25 randomized, controlled trials in which topical pimecrolimus and tacrolimus were compared with topical steroids or with each other; 4186 of 6897 studied patients received one or both immunomodulators.

Tacrolimus was as effective as betamethasone valerate 0.1% at 3 weeks and significantly more effective than hydrocortisone acetate 1%. It was also more effective than a regional treatment strategy that used hydrocortisone on the face and triamcinolone acetonide 0.1% on the trunk and extremities. Tacrolimus 0.1% was significantly more effective than the 0.03% formulation, but only after 12 weeks.

Pimecrolimus was not compared with mild steroids. In one trial, this agent was less effective than betamethasone valerate 0.1%. A comparison of pimecrolimus with tacrolimus 0.03% showed no significant differences in efficacy at 6 weeks. Both agents caused significantly more skin burning than topical steroids.

Comment: Topical steroids will remain the first-line and mainstay therapy for most patients with atopic dermatitis, but these two topical immunomodulators are effective. They are excellent for treating the face and intertriginous sites, where topical steroid-induced atrophy is more likely, and for treating patients who would otherwise require long-term steroids. Rotational and regional strategies that alternate or combine steroids and immunomodulators will satisfy many patients and help to minimize cost.

The FDA's recent black-box warning of a potential cancer risk from use of these drugs (see http://www.fda.gov/cder/drug/advisory/elidel_protopic.htm) is highly controversial and should not deter the proper use of these medications (see http://www.aad.org/public/News/NewsReleases/fda_decision.htm for the response by the American Academy of Dermatology). It is not an either/or proposition. Dermatologists need both topical steroids and topical immunomodulators -- the question is how to maximize benefit while minimizing risk.

— Mary Wu Chang, MD

Published in Journal Watch Dermatology April 12, 2005

Citation(s):

Ashcroft DM et al. Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: Meta-analysis of randomised controlled trials. BMJ 2005 Mar 5; 330:516-24.

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