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  • Title: Cladribine tablets for relapsing-remitting multiple sclerosis: Efficacy across patient subgroups from the phase III CLARITY study.
    Author: Rammohan K, Giovannoni G, Comi G, Cook S, Rieckmann P, Soelberg Sørensen P, Vermersch P, Hamlett A, Kurukulasuriya N, CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) Study Group.
    Journal: Mult Scler Relat Disord; 2012 Jan; 1(1):49-54. PubMed ID: 25876451.
    Abstract:
    BACKGROUND: In the phase III CLARITY study, treatment with cladribine tablets at cumulative doses of 3.5 or 5.25mg/kg over 96 weeks led to significant reductions in annualized relapse rates (ARR) versus placebo in patients with relapsing-remitting multiple sclerosis. Further post hoc analyses of CLARITY study data were conducted to determine the efficacy of cladribine tablets across patient subgroups stratified by baseline characteristics. METHODS: Relapse rates over the 96-week CLARITY study were analyzed in cohorts stratified by demographics; disease duration; treatment history and disease activity at baseline. RESULTS: In the intent-to-treat population (n=437, 433 and 456 in the placebo, cladribine 3.5 and 5.25mg/kg groups, respectively), treatment with cladribine tablets 3.5 and 5.25mg/kg led to consistent improvements in ARR versus placebo in patients stratified by gender; age (≤40/>40 years); disease duration (<3/3-10/>10 years); prior disease-modifying drug treatment (treated/naïve); relapses in the prior year (≤1/2/≥3); Expanded Disability Status Scale score (<3.5/≥3.5); T1 gadolinium-enhancing lesions (presence, absence); and T2 lesion volume (≤median/>median) at baseline (all P≤0.05 for reduction in the relative risk of relapse [cladribine tablets versus placebo]). Significant effects were also observed in patients who had only one relapse in the year prior to study entry (n=306, 303 and 323 in the placebo, cladribine 3.5 and 5.25mg/kg groups, respectively) and who were further stratified according to other measures of disease activity at baseline. CONCLUSIONS: Treatment with cladribine tablets provides consistent reductions in ARR compared with placebo across the spectrum of baseline demographics and disease characteristics represented in the CLARITY study.
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