Multiple sclerosis (MS) is a serious disease that, if left untreated, often leads to disability and reduced quality of life.1 Some of the newer and emerging MS therapies (e.g., natalizumab, fingolimod) hold potential for enhanced efficacy in comparison to more established treatments (i.e., interferon and glatiramer acetate).2 However, the increased efficacy appears to sometimes come at the costs of safety and monitoring. In assessing the risk/benefit ratio for the individual patient, clinicians must synthesize many factors to decide upon an ideal treatment strategy. Acknowledging that there may be the rare patient with fulminant and rapidly disabling early MS who may need a highly effective treatment at the beginning, agents with considerable safety concerns should generally be used as “second line.” The initiation of a safe and effective first-line agent should include a comprehensive plan for monitoring disease activity, with potential for rapid changes in therapy if necessary.
Rationale for a stepped approach to treat patients with MS
New agents will require several years and tens of thousands of patients before we understand their full safety profile. While recent phase III MS clinical trials are relatively large and reasonably long, important adverse events may be discovered only after the approved medicine is launched. Serious safety concerns may be missed if they are uncommon or associated with a long latency. For example, the …
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