Immunomodulatory agents in MS: clinical trials and therapy

Regina Berkovich MD PhD (Dr. Berkovich of the USC Keck School of Medicine and St-Petersburg Pavlov State Medical University received honorariums from Questcor, Teva Pharmaceutical, Acorda, Bayer, and Biogen Idec.)
Daniel Kantor MD (Dr. Kantor of Neurologique Foundation received honorariums from Allergan, Accorda, Avanir, Biogen Idec, Genzyme (Sanofi), Teva Neurosciences, Questcor, Merz, Depmed, Osmotica, Novartis, US World Meds, and Medicis.)
Anthony T Reder MD, editor. (Dr. Reder of the University of Chicago served on advisory boards and as a consultant for Bayer, Biogen Idec, Caremark Rx, Genentech, Genzyme, Novartis, Malinkrodt, Serono, and Teva-Marion.)
Originally released November 12, 2002; last updated June 10, 2013; expires June 10, 2016
Notice: This article has expired and is therefore not available for CME credit.

This article includes discussion of immunomodulatory agents in MS: clinical trials and therapy, immunomodulatory agents in multiple sclerosis, trials in relapsing-remitting multiple sclerosis, and trials in secondary progressive multiple sclerosis. The foregoing terms may include synonyms, similar disorders, variations in usage, and abbreviations.


In the most recent update of this article, the authors review current data on FDA-approved multiple sclerosis relapse treatment options; disease-modifying treatments for long-term management of multiple sclerosis; new data on previously approved disease-modifying treatments, including updated information concerning natalizumab and risk stratification for progressive multifocal leukoencephalopathy; clinical trials leading to FDA approval of fingolimod in 2010 and subsequent changes to the FDA package labeling; and a recently published phase III trial, which led to the FDA approval of teriflunomide in 2012. There is a practical monitoring section for the busy clinician to ensure that patients are being monitored per FDA recommendations.

Key points


• Chronologically, treatment options for multiple sclerosis relapse preceded the disease-modifying treatments introduction.


• There are still 2 FDA-approved methods for treating multiple sclerosis relapses: intravenous methylprednisolone (IVMP) and intramuscular adrenocorticotropic hormone (ACTH), approved in 1979 and 1978 respectively.


• In 1992 there was no FDA-approved disease-modifying treatment for multiple sclerosis.


• As of the end of 2012, there are 9 branded disease-modifying treatments for multiple sclerosis--5 self-injectable, 2 intravenous, and 2 oral.


• In the near future, we expect the approval of 2 more disease-modifying treatments for multiple sclerosis.

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