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Friday

 

Modifying disability in progressive multiple sclerosis

Multiple sclerosis is the most common cause of chronic neurological disability in young adults in developed countries and seems to be increasing in frequency.1, 2 Disease presentation in 80—90% of patients follows an initial phase characterised by bouts of relapsing-remitting neurological dysfunction.3 These relapses are thought to represent focal areas of inflammation in the CNS, and arise with unpredictable frequency and variable recovery.4 However, after an inconsistent interval, most patients then develop a progressive disease course, with a gradual development of disability in the absence of relapses. The later disease phase accounts for most of the permanent disability and is thought to be mediated by neurodegenerative processes including axonal degeneration.5 Although some controversy remains regarding the rate at which conversion to secondary progressive multiple sclerosis takes place, a figure of 2—3% per year with age-related influences is widely accepted.6 The overall effect, in a disorder whose duration exceeds 30 years, is that most patients will, at some stage, develop secondary progressive multiple sclerosis, and at any one time most prevalent patients are in a disease phase for which there is no effective treatment.
Initial therapeutic advances targeted the early inflammatory disease phase, with several licensed immunomodulatory treatments emerging. Treatments available to clinicians for management of relapsing-remitting multiple sclerosis are now substantial. Available drugs all have an effect on relapse frequency, reduction of brain MRI lesion formation, and can reduce permanent disability when defined as worsening with no reversal in 3—6 months. However, the pattern of rising severity and frequency of serious adverse events with increasing drug efficacy needs careful patient selection, clinical management, and surveillance. Despite these limitations, early and effective intervention for relapsing-remitting multiple sclerosis is hoped to have the long-term outcome of delaying or abolishing the progressive phase. Nevertheless, evidence for the long-term outcome of early intervention has so far been elusive and, although a much debated treatment strategy, a reluctance to administer powerful immunomodulators at onset, in a disease which can have a highly variable outcome,7 has made quantification of the effect of early aggressive immunomodulatory treatment on long-term outcome difficult. No licensed drugs have shown a convincing effect on long-term disability, or specifically on progressive disease.

Although identification of interventions that have a significant effect in modification of physical disability in progressive disease is a main aspiration of clinical trials of multiple sclerosis, an obstacle will be the large numbers of patients needed to achieve adequate power when conventional measures of disability are used. Indeed, this challenge might have contributed to negative results in trials of progressive disease to date,8 and more accurate contemporary power calculations are needed to inform future studies that aim to report disability as the primary outcome measure. As a result, effective alternative measures to identify promising drugs in phase 2 studies are needed before large-scale investments in larger trials are considered.
In multiple sclerosis, measurement of brain atrophy has been recognised as a plausible surrogate outcome for disability,9, 10 and some studies of immunomodulatory drugs have shown an effect on reducing this outcome. Further support for the use of change in brain volume in this context has also emerged in an analysis of treatment in relapsing multiple sclerosis that showed a correlation of treatment effect on brain atrophy with the effect on disability (r2=0·48).11 However, the association with effect on disability was greater with use of MRI lesion activity (r2=0·61) and greater still when both MRI outcomes were combined (r2=0·75).11

Story Source: The above story is based on materials provided by THE LANCET
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