title: Interdisciplinary Risk Management in the Treatment of Multiple Sclerosis.
abstract: BACKGROUND
  Multiple sclerosis (MS) is the most common autoimmune disease of the central nervous system. There are at least 150 000 persons with MS in Germany. Recent years have seen the approval of new drugs against.
  
  
  METHODS
  This article is based on pertinent literature retrieved by a selective search in PubMed as well as on documentation of relevant risks and adverse effects in "red hand letters" (information bulletins from pharmaceutical companies to physicians about adverse drug effects) and elsewhere, along with data provided by the German Multiple Sclerosis Competence Network.
  
  
  RESULTS
  In recent years, there have been major advances enabling better, more individualized treatment of patients with MS. Physicians must, however, give due consideration to potentially severe or even life-threatening adverse drug effects. These can include, for example, transaminase elevation (hepatotoxicity), cardio- and nephrotoxicity, or lympho- and leukopenia with a variable risk of infection. Among patients taking natalizumab, the cumulative risk of developing progressive multifocal leukencephalopathy (PML) may be 1:100 or higher, depending on the individual risk profile. Rare cases of PML have also been seen under treatment with fingolimod and dimethyl fumarate. Moreover, any type of immunosuppressive treatment can, at least theoretically, increase the risk of malignant disease. Secondary autoimmune diseases can arise as well: approximately 35% of patients treated with alemtuzumab develop autoimmune thyroid disease within two years, and 2% of patients who take daclizumab have severe autoimmune dermatological side effects. Teriflunomide, fingolimod, natalizumab, mitoxantrone, interferon β1-a/b, and daclizumab can all damage the liver. There are also psychiatric, reproductive, and vaccineassociated risks and side effects that must be considered.
  
  
  CONCLUSIONS
  Newer drugs for MS have enabled more effective treatment, but are also associated with a higher risk of side effects. Interdisciplinary risk management is needed.
authors.affiliation: Institute for Clinical Neuroimmunology, Biomedical Center and Hospital, Ludwig-Maximilians Universität München, Munich; Department of Neurology, Faculty of Medicine, Heinrich Heine University Düsseldorf; Department of Neurology, University Hospital Basel; Munich Cluster for Systems Neurology (SyNergy).
authors.forename: Joachim
authors.initials: J
authors.lastname: Havla
authors.forename: Clemens
authors.initials: C
authors.lastname: Warnke
authors.forename: Tobias
authors.initials: T
authors.lastname: Derfuss
authors.forename: Ludwig
authors.initials: L
authors.lastname: Kappos
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Hartung
authors.forename: Reinhard
authors.initials: R
authors.lastname: Hohlfeld
mesh_terms: D005858:Germany; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D009103:Multiple Sclerosis / Q000188:drug therapy*; D012308:Risk Management
chemical_list: D007166:Immunosuppressive Agents