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news.Merck KGaA has presented new data from pre-specified and post-hoc analyses of the Phase III Clarity clinical trial providing further understanding on Cladribine tablets as a potential new therapeutic option for relapsing forms of multiple sclerosis (MS) at the 62nd Annual Meeting of the American Academy of Neurology (AAN).
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Cladribine is a small molecule that may interfere with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are thought to be involved in the pathological process of MS.
The Clarity study was a two-year (96-week), randomised, double-blind, placebo-controlled, international trial. It randomised 1,326 patients with relapsing-remitting MS according to the revised McDonald criteria.
Study participants were randomised to one of three different treatment groups consisting of two different dose regimens of Cladribine tablets or matching placebo tablets (1:1:1 ratio). Cladribine tablets were given in two (3.5mg/kg total dose) or four (5.25mg/kg total dose) treatment courses in the first year, with each course consisting of once daily administration for four to five consecutive days (depending on patient weight), which means study patients took Cladribine tablets for 8 to 20 days during the year. In the second year, two treatment courses were administered to all patient groups, meaning that patients took Cladribine tablets for 8 to 10 days during the year.
The data from Clarity study shows an increase in the proportion of patients with disease activity-free status compared with the placebo group over the entire 96-week study (43% and 44% of patients treated with Cladribine tablets total dose of 3.5mg/kg and 5.25mg/kg respectively compared with 16% of patients who received placebo- p<0.001 for both Cladribine tablets groups) with statistical findings as early as 24 weeks (67% and 70% of patients treated with Cladribine tablets total dose of 3.5mg/kg and 5.25mg/kg respectively compared with 39% of patients who received placebo – p<0.001 for both Cladribine tablets groups).
Additionally a reductions in annualised relapse rate (ARR) compared to the placebo group over 96 weeks across the spectrum of baseline demographics and disease characteristics included in the Clarity study (gender, age, treatment history, number of relapses in the 12 months preceding study entry, baseline disease disability, baseline MRI activity and burden of disease).
The data also demonstrated areduced consumption of healthcare resources, a decreased need for societal support, improvements in patient productivity and reductions in total non-drug expenditure, relative to placebo, as measured by data collected in the Clarity study with a ‘resource utilisation form’ at baseline and at scheduled patient visits.
Reportedly, a decrease of proportions of circulating CD4+ T cells relative to the total number of lymphocytes at the end of treatment periods compared to baseline, while the proportions of other lymphocyte subtypes (CD8+ T, B and natural killer cells) were preserved or increased relative to total lymphocytes.
Bernhard Kirschbaum, head of global research and development of the Merck Serono division, said: “The relevance of the Clarity study is further substantiated by the series of additional analyses presented at AAN and we are committed to continuing to work with regulatory authorities to bring Cladribine tablets to patients at the earliest point in time.”