Abstract

Therapy of relapsing-remitting multiple sclerosis (MS) has become more effective, but this progress has unfortunately been associated with more serious risks. Since 3 years natalizumab has been licensed as the first monoclonal antibody for the treatment of a neurological autoimmune disease. In addition, there is now an increasing off-label use of rituximab and other monoclonal antibodies in a variety of immune-mediated neurological disorders. Experience and insights arising from applying these therapies will be used to define indications, logistics for monitoring treatment and adverse events, and some diagnostic and therapeutic algorithms for future innovative therapies for MS and their potential complications. This article is based on deliberations of a symposium held by an expert group of the German MS society (DMSG) which had a focus on natalizumab. In the future, when other novel therapeutic compounds are to be licensed, this work will be extended, updated and reported. This will help to improve the practical handling of potential complications of therapy in both inpatient and outpatient settings. A structured interaction between different levels of health-care providers will be an important part of establishing robust quality standards aiming at a high level of treatment safety. These structural aspects are addressed in a back-to-back article.

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