DARMSTADT, Germany, February 9, 2017 /PRNewswire/ --
- Post hoc analysis of Phase III CLARITY study data recently published in Multiple
Sclerosis Journal showed statistically significant reduction in brain atrophy in
patients on a short course of investigational Cladribine Tablets over two
years compared with patients receiving placebo
- These findings correlated with effects on clinical progression as measured by the EDSS
scale, a method of quantifying disability in multiple sclerosis
Merck, a leading science and technology company, today announced the publication of the results of a post hoc analysis of the Phase III CLARITY study in Multiple Sclerosis Journal. The analysis showed that Cladribine Tablets reduced the annualised rate of brain volume loss - also known as brain atrophy - compared with placebo in patients with relapsing remitting multiple sclerosis (RRMS).
In addition, the analysis found that patients with lower rates of brain atrophy showed the highest probability of remaining free from disability progression at two years. This supports existing findings that increased brain volume loss over time is associated with worse clinical outcomes, such as increased disability progression and cognitive changes, in patients with multiple sclerosis.
"Evidence shows that brain atrophy in general accumulates throughout the course of multiple sclerosis and is associated with disability progression. This analysis is important because it confirms the link between reduced brain atrophy and reduced disability progression found in the CLARITY study," said Nicola De Stefano, lead author of the publication and Associate Professor of Neurology, Department of Medicine, Surgery and Neuroscience, University of Siena.
The CLARITY study was a two-year (96-week), randomised, double-blind, placebo-controlled Phase III study of Cladribine Tablets in 1,326 people with RRMS. The CLARITY study primary (rate of relapse at 96 weeks) and key secondary endpoints (proportion of patients who were relapse free and the time to sustained progression of disability) were met. These outcomes and safety results were published in The New England Journal of Medicine.
The brain atrophy analysis evaluated the effect of Cladribine tablets on brain volume loss (BVL) over 2 years in RMS and the association of BVL with confirmed disability progression in 1,025 (77.3%) of the patients in CLARITY. The mean percentage brain volume loss per year was significantly reduced in patients treated with Cladribine Tablets 3.5 mg/kg (-0.56%plus or minus0.68, p=0.010, n=336) and 5.25 mg/kg (-0.57%plus or minus0.72, p=0.019, n=351) compared with patients treated with placebo (-0.70%plus or minus0.79, n=338). The risk of disability progression was also significantly lower in patients treated with Cladribine Tablets 3.5 mg/kg (HR 0.63, 95% CI 0.438, 0.894; p=0.010) and 5.25 mg/kg (HR 0.58, 95% CI 0.406, 0.833; p=0.003) than in those treated with placebo. After adjusting for treatment group, percentage brain volume loss per year showed a significant correlation with the cumulative probability of disability progression in the overall study population (HR 0.67, 95% CI 0.571, 0.787; p