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Interdisciplinary Risk Management in the Treatment of Multiple Sclerosis

Dtsch Arztebl Int. 2016 Dec 26;113(51-52):879-886. doi: 10.3238/arztebl.2016.0879.

Authors/Editors: Havla J, Warnke C, Derfuss T, Kappos L, Hartung HP, Hohlfeld R.
Publication Date: 2016

2016_12_havla

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 MS with
various mechanisms of action and differing adverse effect profiles.
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.
Conclusion: 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.

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