Abstract
In reaction to the marketing suspension recommended by the European Medicines Agency, Genentech announced the voluntary withdrawal of efalizumab. Since June 8, 2009, efalizumab has been unavailable. Despite the fact that the use of efalizumab is now ceased, results of studies with efalizumab will remain relevant, especially about its use in an off-label setting for indications other then chronic plaque psoriasis. New biologics as well as chemicals are being developed targeting similar T-cell-mediated pathways. Indications for these new compounds other than chronic plaque psoriasis could be selected based on this systematic review. With this article we aimed to summarize the evidence of effectiveness and/or the efficacy and safety of efalizumab in off-label dermatological use, and to illustrate the time scale in which dermatological medicines are offered off-label to dermatological patients. We found some evidence supporting the effectiveness of efalizumab in palmoplantar pustulosis, atopic dermatitis, lichen planus and cutaneous lupus erythematosus. In total, 12 serious adverse events occurred, one due to an infection. Efalizumab was given off-label within half a year after registration of the drug for plaque psoriasis.
Acknowledgements
The authors thank J La Verge for his contribution in the data extraction and analysis and R Spijker for his assistance in the literature search strategy.
Financial & competing interests disclosure
ME Schram and PI Spuls have no conflicts of interest. JD Bos has acted as an incidental consultant and speaker for Merck Serono, the distributor of efalizumab (Raptiva®), as well as for other biotechnological and pharmaceutical companies including Abbott, ApoPharma, Astellas, Leo Pharma, Novartis, Shiseido and Wyeth. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.