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December 2005

AMEVIVE’s Advertisements: Problematic?

Arch Dermatol. 2005;141(12):1602-1604. doi:10.1001/archderm.141.12.1602-b

Six-page glossy advertisements for AMEVIVE (alefacept) have become nearly ubiquitous in dermatology journals—including the Archives of Dermatology—since the drug’s approval in early 2003.1 I believe that the ads are problematic.

First, the ads focus on a formulation of AMEVIVE that no longer exists. Only intramuscular (IM) AMEVIVE has been available since October 3, 2003, when poor demand for intravenous (IV) AMEVIVE prompted the manufacturer (Biogen, Inc; now Biogen Idec, Inc [as of November 2003], Cambridge, Mass) to discontinue it.2 Nevertheless, effectiveness data featured in bar graphs prominently displayed on the third page of each ad reflect clinical-trial experience with IV—not IM—AMEVIVE (Figure, A). Data from IV and IM trials are similar, but not identical. In the Figure, compare A with B, which presents bar graphs that I constructed using data from IM trials. (Interestingly, these results were not presented in published reports of the IM AMEVIVE trials3,4; the data were provided on request from Biogen Idec, Inc, where they are “on file.”) With IV AMEVIVE, more patients achieved a 75% or greater reduction on the Psoriasis Area and Severity Index (PASI-75) after 2 courses than after a single course (26% vs 14%)5; with IM AMEVIVE, the percentage of patients achieving PASI-75 after 2 courses was slightly lower than that after a single course (20% vs 21%). Whether these small differences are clinically important is for dermatologists and patients to decide, but they cannot decide if currently relevant data are not presented in the ad.