Monoclonal antibodies are attractive therapeutic agents because they allow the selective modulation of defined molecular targets. However, despite their "molecular precision," and despite promising results in animal models, clinical experience has shown that mAb treatment can have completely unexpected effects when applied to patients. With the ongoing progress in medical research we have entered new therapeutic avenues, but also have had to face a growing number of severe, tragic side effects. Whereas in the past, the available MS therapeutics were administered and even combined without severe problems, the latest generation of immunobiologicals seems to carry unprecedented risks that could not be identified by sophisticated in vitro or in vivo experimental models. This seems at first view a paradox, because mitoxantrone and other cytostatic drugs also bear immanent risks at least in the same range. Most probably we have to consider human psychology, which had expected these novel molecular tools as "miracle drugs," with these side effects coming as a great surprise. In the future we must improve "pharmacovigilance" procedures, amend regulatory conditions for phase I studies, and keep watching our patients carefully. Especially progressive MS needs novel therapeutic approaches. Efforts must be continued to develop better and still safe therapies.
Acknowledgements. The authors thank Dr. Emanuel-le Waubant for sharing information on rituximab trials, and gratefully acknowledge support by the Max-Planck Society, Deutsche Forschungsgemeinschaft (DFG, SFB 571), and the Hermann-and-Lilly Schilling Foundation.
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