Principles of a New Treatment Algorithm in Multiple Sclerosis

Hans-Peter Hartung; Xavier Montalban; Per Soelberg Sorensen; Patrick Vermersch; Tomas Olsson


Expert Rev Neurother. 2011;11(3):351-362. 

In This Article

Five-year View

Given their proven efficacy and well-established tolerability, IFNβ formulations and glatiramer acetate will most likely remain a central part of MS therapy 5 years from now, particularly for patients with early disease (e.g., CIS) or less active disease. Depending on regulatory factors, the respective roles of oral fingolimod and oral cladribine will most likely have been established at this time through additional clinical experience in clinical practice and the passage of sufficient time to reveal any unexpected safety signals. The role of natalizumab may have changed considerably in 5 years' time if a commercialized JCV-assay allows the determination of patients with a very low risk of PML.

The current treatment landscape is also likely to change dramatically over the next 5 years due to the arrival of other new treatments for MS. Five drugs are currently being investigated in Phase III trials.[73] Two of these, laquinimod and BG-12, are oral agents,[74,75] while several parenterally administered therapeutics are also in Phase III development. Of these, daclizumab and pegylated IFNβ-1a appear the most promising.[60,76] Daclizumab is being investigated as a once-monthly SC formulation and has a favorable side-effect profile.[60] Compared to current IFNβ formulations, subcutaneous pegylated IFNβ-1a has the benefit of requiring less frequent administration (every 2 weeks or once monthly). Intravenous alemtuzumab is also in Phase III trials. However, it has been associated with considerable immunosuppression and serious autoimmune adverse reactions.[77] The role of these agents in MS will ultimately be determined by the results of their respective Phase III trials and by their ability to overcome FDA and CHMP regulatory hurdles.


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