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Pivotal trials have demonstrated partial, short-term benefit from treatment with immunomodulatory agents in patients with either clinically isolated syndromes (patients at an increased risk of developing multiple sclerosis [MS]1,2) or relapsing-remitting MS (RRMS).3–13 These insights come largely from using the accessible outcomes of relapse behavior and sensitive MRI measures of disease activity and are most easily demonstrated when tested in trials that are randomized and utilize a placebo control comparison group.
No one has solved the riddle of how best to conduct long-term, blinded MS trials and, consequently, definitive evidence that treatment protects against progression in disability remains elusive. The report by Kappos et al.14 attempts to make the most of the imperfect world of extension trials, a methodology that has been used by others to provide similar insight on the value of prolonged treatment with glatiramer acetate.15
The Kappos et al. article exemplifies the challenges facing both investigators and physicians in contemporary MS practice. What emerges is of interest, but there are important limitations that merit attention. The authors …
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