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This chapter reviews the mechanism of action of cladribine, summarizes data from clinical trials in patients with multiple sclerosis (MS), and provides guidance on the management of these patients in clinical practice. The study of parenteral cladribine showed encouraging results, which lead to the development of an oral tablet formulation. Cladribine is rapidly absorbed with Cmax within 30- 50 minutes after oral administration. CLARITY, a 96-week, placebo-controlled Phase 3 study of cladribine tablets as an annual short-course oral monotherapy in RRMS, was recently completed and the principal results published. Benefit of doses of cladribine over placebo was demonstrated for a variety of clinical and imaging end-points. The most common adverse events in the patients were lymphopenia, headache, nasopharyngitis, and upper respiratory tract infections (URTI). The outcomes observed during the CLARITY study were associated with a reduced consumption of health care resources and a decreased need for medical and societal support.
Lesions that are hyperintense on T1 images after intravenous administration of gadolinium chelate represent focal areas of blood-brain barrier (BBB) disruption, which in multiple sclerosis (MS) are presumed to represent areas of active inflammation. T2 lesion burden early in the disease is the best known magnetic resonance imaging (MRI) predictor of long-term disability and brain atrophy. Several imaging approaches have been proposed to provide additional pathologic specificity with greater ability to monitor tissue integrity both within lesions visible on standard imaging, normal appearing brain tissue (NABT), and gray matter (GM). Phase 1 trials aim to expose a relatively small number of subjects to a new medication for a short period of time, monitoring primarily for safety concerns. MRI-based studies have become standard for Phase 2 (proof-of-concept) trials of disease modification in MS. Primary outcomes for Phase 3 (pivotal) trials remain relapses and disability progression.
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