Feb 4 2016
By Lucy Piper, Senior medwireNews Reporter
Natalizumab may be superior to fingolimod for preventing relapses during the first year of treatment in patients with relapsing–remitting multiple sclerosis (RRMS), observational study findings show.
In the absence of randomised controlled trials (RCTs) and given the heterogeneity of evidence in the literature, the researchers believe their findings “provide additional information that may help physicians choose second-line treatment for patients with RRMS.”
Both treatments improved control of symptoms, but during the first year of treatment, more of the 326 patients given natalizumab had at least one relapse than did the 303 patients given fingolimod, at 21.2% versus 27.1%.
After adjustment for group differences at baseline and propensity score adjustment for confounding factors, the estimated relapse rates were 21.1% for natalizumab versus 30.4% for fingolimod, a significant difference.
This significant difference was maintained over 2 years of treatment, at which point the adjusted relapse rates were 30.9% for the natalizumab group and 41.7% for the fingolimod group.
Researcher David Laplaud (INSERM U1064, Nantes, France) and colleagues estimate that fingolimod treatment was associated with a 60% and 50% greater risk of relapse at 1 and 2 years, respectively.
Magnetic resonance imaging findings also showed significant differences between the two treatment groups in terms of the presence of lesions at 1 and 2 years.
For the natalizumab-treated patients, adjusted rates of gadolinium-enhancing lesions and new T2 lesions were 9.3% and 10.6%, respectively, at 1 year and 9.1% and 16.9% at 2 years. This compared with corresponding rates among fingolimod-treated patients of 29.8% and 29.6% at 1 year and 22.1% and 34.1% at 2 years.
Deterioration on the Expanded Disability Status Scale was significantly reduced with both treatments and there was no difference between the two groups.
The researchers comment in Neurology that their observational study “provides Class IV evidence for the superiority of natalizumab over fingolimod to prevent relapse at 1 year.”
However, they acknowledge that the choice of treatment is not dependent solely on the efficacy of the molecule and an important consideration not assessed in their study was progressive multifocal leukoencephalopathy risk – a potential side effect of natalizumab treatment.
Given this, they say that “interpretation of the results should be made with caution until RCTs are available to compare the 2 molecules.”
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