Mavenclad (cladribine) appears to be better at lowering relapse rates during the first two years of disease in relapsing-remitting multiple sclerosis (RRMS) patients than other MS therapies, including interferon, Copaxone (glatiramer acetate) and Tecfidera (dimethyl fumarate), a head-to-head observational study found.
Mavenclad, however, was less effective at reducing these rates than Tysabri (natalizumab).
The study “Cladribine vs other drugs in MS,” comparing data from Mavenclad’s pivotal trial with data collected on patients across Italy on a first disease-modifying therapy, was published in the journal Neurology.
Mavenclad, developed and marketed by EMD Serono (known as Merck KGaA outside North America), is an oral, short-course therapy approved for relapsing forms of MS in more than 50 countries, including in the U.S., European Union, Australia, and Canada.
The therapy, given in two treatment courses of two weeks each, separated by about one year, works by lowering the number of immune cells in the bloodstream, the cause of neurodegeneration in MS.
Mavenclad’s approval was supported by findings from a clinical trial program involving a total of 1,976 MS patients, including the Phase 3 CLARITY trial (NCT00213135).
In the CLARITY study, 1,326 RRMS patients were randomized to a placebo or to one of two doses of Mavenclad, 3.5 and 5.25 mg/kg. The approved dose is 3.5 mg/kg.
Results showed that both doses were superior to placebo in suppressing relapses, and in increasing the time patients remained relapse-free. Treatment with 3.5 mg/kg of Mavenclad reduced the risk of six-month disability progression by 47%, compared with placebo, as measured by the expanded disability status scale (EDSS).
However, few studies have compared Mavenclad’s effectiveness with other approved RRMS therapies.
“We aim to fill in the gap in the current RRMS treatment landscape, as no direct head-to-head comparisons of cladribine with other common immunotherapies have yet been conducted,” the scientists wrote.
Researchers at the University of Genoa and colleagues performed a retrospective comparative analysis of data from the CLARITY study and the i-MuST study, a retrospective database involving 24 Italian MS centers.
The i-MuST database included 3,150 patients, diagnosed between 2010 and 2018, who began treatment with disease-modifying therapies (DMTs) and who satisfied the inclusion criteria for the CLARITY study.
In total, they analyzed data covering 2,204 patients from i-MuST and 945 patients from CLARITY. Patients in i-MUST tended to be younger than those in CLARITY, but their EDSS levels were “generally well balanced,” the study noted.