Oral cladribine phase 3 results show relapse reductions, lower total cost for patients with RRMS

New analyses from the phase 3 CLARITY (Cladribine Tablets Treating MS Orally) study reveal improvements in disease-free activity and the annualized relapse rate and a reduction in the use of healthcare resources in cladribine recipients compared with placebo in patients with relapsing-remitting multiple sclerosis (RRMS).

Key Points

New analyses from the phase 3 CLARITY (Cladribine Tablets Treating MS Orally) study reveal improvements in disease-free activity and the annualized relapse rate (ARR) and a reduction in the use of healthcare resources in cladribine recipients compared with placebo in patients with relapsing-remitting multiple sclerosis (RRMS).

The updates were presented during several presentations delivered at the 62nd annual meeting of the American Academy of Neurology, Toronto.

CLARITY was a 96-week, double-blind study in which 1,320 patients with RRMS were randomly assigned to 1 of 2 doses of cladribine or placebo orally. Patients randomly assigned to cladribine were treated with either 2 (3.5 mg/kg total dose) or 4 (5.25 mg/kg total dose) courses during the first year, with each course consisting of once-daily administration for 4 or 5 days (8 to 20 days of treatment total during the first year). During the second year, all patients randomly assigned to cladribine were treated with 2 courses (total treatment of 8 to 10 days during year 2).

Among the new findings presented: