FP36-WE-03 MRI outcomes of short-course oral treatment with cladribine tablets for relapsing-remitting multiple sclerosis (RRMS) in the 96-week, phase III, double-blind, placebo-controlled CLARITY study

Comi, G.; Cook, S; Giovannoni, Gavin; Rammohan, Kottil; Rieckmann, Peter; Soelberg-Sorensen, Per; Vermersch, P.; Chang, Pei‐Hung; Hamlett, A; Musch, B; Fevr, T; Viglietta, Vissia; Greenberg, SJ

doi:10.1016/s0022-510x(09)70458-7

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“…MRI analyses at 96 weeks showed relative reductions in T1 Gd-enhancing lesions with cladribine in the 3.5 and 5.25 mg/kg groups of 85.7% and 87.9%, respectively, versus placebo (both p < 0.001) [12,36]. Relative reductions in active T2 lesions of 73.4% and 76.9% were observed with cladribine tablets therapy in the 3.5 and 5.25 mg/kg groups, respectively, versus placebo (both p < 0.001).…”

Section: Clinical Efficacymentioning

confidence: 99%

Cladribine to Treat Relapsing Forms of Multiple Sclerosis

2017

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Cladribine is a purine nucleoside analogue that selectively depletes peripheral lymphocytes without a major impact on cells of the innate immune system. An oral formulation of cladribine has been developed to be given as short courses over two annual cycles. Oral cladribine results in the peripheral depletion of lymphocytes that is gradual, occurring over several weeks, and is not associated with a cell lysis syndrome, has a greater impact on B cells than T cells, and is followed by gradual reconstitution of the peripheral lymphocyte counts over several months. Oral cladribine is effective in relapsing forms of multiple sclerosis. As a selective immune reconstitution therapy (SIRT), cladribine acts as a short-term immunosuppressant, relative to other maintenance immunosuppressive therapies that result in long-term immunosuppression. The main safety signal that has emerge relates primarily to herpes zoster infection, which was more common in patients with higher grades of lymphopenia, in particular grade 3 and 4 lymphopenia. Data from the oral cladribine extension trial and safety register, and reanalysis of the pivotal phase III trial has indicated that oral cladribine is unlikely to be associated with an increased short- to intermediate-term risk of malignancy.

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Section: Clinical Efficacymentioning

confidence: 99%