Evidence-Based Dermatology: Research Commentary |

The Misperception That Clinical Trial Data Reflect Long-term Drug Safety:  Lessons Learned From Efalizumab's Withdrawal

Tamar Nijsten, MD, PhD; Phyllis I. Spuls, MD, PhD; Luigi Naldi, MD; Robert S. Stern, MD
Arch Dermatol. 2009;145(9):1037-1039. doi:10.1001/archdermatol.2009.188.
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Commentary on: Press Release: European Medicines Agency recommends suspension of the marketing authorisation of Raptiva (efalizumab).

The European Medicines Agency


On February 19, 2009, the European Medicines Agency (EMEA) and the Food and Drug Administration (FDA) issued statements about the safety concerns regarding the risk of progressive multifocal leukoencephalopathy (PML) with the use of efalizumab in patients with psoriasis.1,2 That day, the EMEA recommended suspending sales of efalizumab because of an altered risk to benefit ratio and to carefully discontinue this drug in patients using it in the next 3 months. The FDA issued a public health advisory and changed the labeling of efalizumab to include a “black box” warning. On April 8, 2009, the company voluntarily withdrew efalizumab from the US market.2

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Risk to benefit ratio of efalizumab in treatment of psoriasis in 2009. ADR indicates adverse drug reaction; HRQOL, health-related quality of life; PASI-75, 75% reduction in Psoriasis Area and Severity Index; PMS, postmarketing study; and PsA, psoriatic arthritis.

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