Erschienen in:
01.03.2011 | Adis Drug Profile
Cladribine Tablets
In Relapsing-Remitting Multiple Sclerosis
verfasst von:
Victoria J. Muir, Greg L. Plosker
Erschienen in:
CNS Drugs
|
Ausgabe 3/2011
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Abstract
Cladribine, an immunosuppressant that selectively reduces peripheral lymphocyte
levels, has potential as an oral therapy for relapsing-remitting multiple sclerosis.
An oral (tablet) formulation is being investigated in clinical trials.
In the large, well designed, phase III CLARITY trial, short-course treatment
with oral cladribine (cumulative dose of 3.5 or 5.25mg/kg) resulted in a
significantly greater reduction in annualized relapse rates at 96 weeks compared
with placebo in patients with relapsing-remitting multiple sclerosis.
Improvements in the annualized relapse rate with oral cladribine were
independent of key baseline patient characteristics which included age, sex,
previous treatment with disease-modifying drugs and the number of relapses in the
previous 12 months.
In addition, a significantly higher proportion of patients were relapse-free at
96 weeks and there were significant reductions in the risk of 3-month sustained
progression of disability in cladribine recipients compared with placebo
recipients.
The mean numbers of brain lesions on magnetic resonance imaging were also
significantly reduced with cladribine compared with placebo in the CLARITY
trial.
Lymphocytopenia, herpes zoster infections and neoplasms (including malignancies)
were more common in cladribine than placebo recipients.