New analyses of efficacy and safety data for investigational Cladribine Tablets in poster presentations at the Annual Meeting of the American Academy of Neurology ( AAN) in Boston, Massachusetts, were presented.
The findings from a retrospective subgroup analysis of the phase III CLARITY trial in 289 patients with high disease activity have demonstrated statistically significant reduction in the risk of disability progression and relapse with Cladribine tablets at a dose of 3.5 mg/kg ( n=140 ) compared with placebo ( n=149 ) in relapsing multiple sclerosis patients who were either treatment naïve or had prior disease modifying drug ( DMD ) exposure.
The analysis demonstrated that treatment with Cladribine tablets 3.5 mg/kg was associated with a larger reduction in the risk of 6-month confirmed EDSS progression in patients with high disease activity ( 82%; P=0.0001 ) than observed in the overall CLARITY population ( 47%; P=0.0016 ) vs placebo.
Additionally, data showed that Cladribine tablets reduced the relative risk of annualised relapse rate in patients with high disease activity ( 67%; P less than 0.0001 ) compared with the overall CLARITY population ( 58%; P less than or equal to 0.0001 ).
The study found that relapse and treatment history as well as MRI characteristics can help to identify patients who are at increased risk of experiencing relapses and disability progression.
Cladribine tablets is thought to selectively target the adaptive immune response in multiple sclerosis, and may be able to address a medical need in those patients already at higher risk of disability progression or relapses.
A safety analysis of patients given Cladribine tablets for 20 days over two years in either CLARITY or CLARITY Extension showed that, following the 10-day dosing period in treatment year 1, median lymphocyte counts were reduced to a low of 1.00×10(9)/L. However, by the end of treatment year 1 and 2, median lymphocyte counts had recovered to within the normal range.
In the 2-year CLARITY study, the most commonly reported adverse event in patients treated with Cladribine tablets was lymphopenia.
The incidence of infections was 48.3% with Cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators. ( Xagena )
Source: EMD Serono, 2017