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Jean-Hilaire Saurat, MD

Arch Dermatol. 2009;145(6):706.

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The thorough review and thoughtful comments are greatly appreciated. The payoff for having "resisted the temptation of doing just a placebo-controlled study" was that this study provided the most robust scientific results to date on the relative clinical benefits and risks of traditional systemic vs biological therapies and may thereby help shape the evolving treatment algorithm for psoriasis. Including a placebo control, requiring patients to have been naïve to methotrexate and anti-TNF therapy, and using a double-dummy design and separate efficacy and safety assessors made the study onerous to conduct but also eliminated or minimized potential biases. In response to Batchelor et al, we offer the following:

(1) The statistical analysis plan for the CHAMPION study¹ prespecified that if superiority of adalimumab to placebo and noninferiority of adalimumab to methotrexate were first established, only then would superiority of adalimumab to methotrexate be tested. This stepwise . . . [Full Text of this Article]

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Adalimumab vs Methotrexate for the Treatment of Chronic Plaque Psoriasis
Jonathan M. Batchelor, John R. Ingram, and Hywel Williams
Arch Dermatol. 2009;145(6):704-706.
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