Evolution of multiple sclerosis treatment: next generation therapies meet next generation efficacy criteria.

摘要

Multiple sclerosis is thought to be the leading cause of neurological disability in young adults in developed countries, and in most patients is thought to be mediated by a persistant inflammatory reaction in the CNS. The underlying pernicious interplay between the immune system and the CNS has led to intensive joint research efforts, and eventually to the introduction of the first disease-modifying treatments in the 1990s. Beta interferons and glatiramer acetate have set the stage for multiple sclerosis therapy development: the methods and clinical efficacy in all subsequent major trials have been benchmarked against the pivotal approval studies for these agents. Phase 3 studies have primarily focused on a single parameter such as relapse rate and disability progression, whereas concomitant parameters such as subclinical inflammatory activity or lesion burden detected by MRI are regarded as secondary endpoints only.