Safety and efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis: Results from the randomized extension trial of the CLARITY study

In the 2-year CLARITY study, cladribine tablets significantly improved clinical and magnetic resonance imaging (MRI) outcomes (vs placebo) in patients with relapsing-remitting multiple sclerosis (MS). To assess the safety and efficacy of cladribine treatment in a 2-year Extension study. In this 2-ye...

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Published in:Multiple sclerosis Vol. 24; no. 12; p. 1594
Main Authors: Giovannoni, Gavin, Soelberg Sorensen, Per, Cook, Stuart, Rammohan, Kottil, Rieckmann, Peter, Comi, Giancarlo, Dangond, Fernando, Adeniji, Abidemi K, Vermersch, Patrick
Format: Journal Article
Language:English
Published: England 01.10.2018
Subjects:
Adult
Cladribine - therapeutic use
Double-Blind Method
Female
Humans
Immunosuppressive Agents - therapeutic use
Longitudinal Studies
Lymphopenia - chemically induced
Lymphopenia - epidemiology
Male
Middle Aged
Multiple Sclerosis, Relapsing-Remitting - drug therapy
Treatment Outcome
CLARITY Extension
Relapsing–remitting multiple sclerosis
cladribine tablets
randomized trial
safety
efficacy
ISSN:1477-0970, 1477-0970
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Summary:In the 2-year CLARITY study, cladribine tablets significantly improved clinical and magnetic resonance imaging (MRI) outcomes (vs placebo) in patients with relapsing-remitting multiple sclerosis (MS). To assess the safety and efficacy of cladribine treatment in a 2-year Extension study. In this 2-year Extension study, placebo recipients from CLARITY received cladribine 3.5 mg/kg; cladribine recipients were re-randomized 2:1 to cladribine 3.5 mg/kg or placebo, with blind maintained. A total of 806 patients were assigned to treatment. Adverse event rates were generally similar between groups, but lymphopenia Grade ⩾ 3 rates were higher with cladribine than placebo (Grade 4 lymphopenia occurred infrequently). In patients receiving cladribine 3.5 mg/kg in CLARITY and experiencing lymphopenia Grade ⩾ 3 in the Extension, >90% of those treated with cladribine 3.5 mg/kg and all treated with placebo in the Extension, recovered to Grade 0-1 by study end. Cladribine treatment in CLARITY produced efficacy improvements that were maintained in patients treated with placebo in the Extension; in patients treated with cladribine 3.5 mg/kg in CLARITY, approximately 75% remained relapse-free when given placebo during the Extension. Cladribine tablets treatment for 2 years followed by 2 years' placebo treatment produced durable clinical benefits similar to 4 years of cladribine treatment with a low risk of severe lymphopenia or clinical worsening. No clinical improvement in efficacy was apparent following further treatment with cladribine tablets after the initial 2-year treatment period in this trial setting.
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ISSN:1477-0970
1477-0970
DOI:10.1177/1352458517727603