New Agents for Multiple Sclerosis and the Difficulties that Lie Ahead
New Agents for Multiple Sclerosis and the Difficulties that Lie Ahead
US Neurology, 009;5(1):54-5
Abstract
A host of new oral agents are being developed for use in relapsing forms of multiple sclerosis (MS). Although many of these agents may be both safe and effective, they could fail in clinical trials because the population of patients enrolled in such trials may behave in a fashion not taken into account by the statistical assumptions used in trial planning. In recent trials on study relapse, rates have been far lower than those observed in earlier clinical trials. This could decrease the power of a trial and result in failure to meet statistical significance even if the agent in question is effective. The same problem could also result in the failure of trials to meet disability outcomes. If too few patients progress on trial it may be difficult to demonstrate an effect on disability progression. The outcome of current MS clinical trials may stimulate the development of new designs and surrogate markers.
Keywords
Multiple sclerosis, clinical trials, relapse rate, oral agents, disability progression
Disclosure: Douglas R Jeffery, MD, PhD, has been a speaker for Teva, Novartis, Bayer, and Biogen and a consultant for Teva, Biogen, Bayer, Novartis, Serono, and GSK, and has received research support from Bayer, Biogen, Teva, and Serono.
Received: November 3, 2008 Accepted: July 27, 2009
Correspondence: Douglas R Jeffery, MD, PhD, Department of Neurology, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157 E: djeffery@wfubmc.edu
The future of therapeutic alternatives in multiple sclerosis (MS) at first glance appears brighter now than at any time in the history of modern MS therapeutics. A host of new agents, both oral and intravenous, are in various stages of development. Patients and physicians alike have been clamoring for oral agents and drugs with greater efficacy and safety and better side-effect profiles than those currently available. Of the oral agents in phase II or III clinical trials, there are cladribine, laquinimod, fingolimod, BG-12, teriflunamide, and oral VLA-4 antagonists. There are also new parenteral agents that promise better efficacy but are not as far along in development as the oral agents. These include dacluzimab, ofatumumab, ocreluzumab, alemtuzumab, and atacicept. While there is considerable excitement about the newer agents on the part of patients and physicians, problems with clinical trial design could prevent these agents from coming to market even though they may be safe and effective.
To read full article please click here
Multiple sclerosis, clinical trials, relapse rate, oral agents, disability progression, multiple sclerosis causes, multiple sclerosis prognosis, motor neurone disease, ambulation indes multiple sclerosis, neurological disorders,
