Oral cladribine for relapsing multiple sclerosis

January 01, 0001

Oral cladribine for relapsing multiple sclerosis

Cladribine provides immunomodulation through selective targeting of lymphocyte subtypes. These authors from multiple countries report the results of a 96-week phase 3 trial of a short-course oral tablet therapy in patients with relapsing-remitting multiple sclerosis. They randomly assigned 1326 patients in an approximate 1:1:1 ratio to receive one of two cumulative doses of cladribine tablets (either 3.5 mg or 5.25 mg per kilogram of body weight) or matching placebo, given in two or four short courses for the first 48 weeks, then in two short courses starting at week 48 and week 52 (for a total of 8 to 20 days per year). The primary end point was the rate of relapse at 96 weeks.

They found: "Among patients who received cladribine tablets (either 3.5 mg or 5.25 mg per kilogram), there was a significantly lower annualized rate of relapse than in the placebo group (0.14 and 0.15, respectively, vs. 0.33), a higher relapse-free rate (79.7% and 78.9%, respectively, vs. 60.9), a lower risk of 3-month sustained progression of disability (hazard ratio for the 3.5-mg group 0.67, and hazard ratio for the 5.25-mg group 0.69), and significant reductions in the brain lesion count on magnetic resonance imaging (MRI). Adverse events that were more frequent in the cladribine groups included lymphocytopenia (21.6% in the 3.5-mg group and 31.5% in the 5.25-mg group, vs. 1.8%) and herpes zoster (8 patients and 12 patients, respectively, vs. no patients)."

The authors concluded: "Treatment with cladribine tablets significantly reduced relapse rates, the risk of disability progression, and MRI measures of disease activity at 96 weeks. The benefits need to be weighed against the risks."

Another potential option for oral treatment of multiple sclerosis.

For the full abstract, click here.

N Engl J Med published online 20 January 2010
© 2010 to the Massachusetts Medical Society
A Placebo-Controlled Trial of Oral Cladribine for Relapsing Multiple Sclerosis. Gavin Giovannoni, Giancarlo Comi, Stuart Cook, et al. Correspondence to: Dr. Giovannoni: [email protected]

Category: N. Neurological, Keywords: multiple sclerosis, MS, cladribine, oral treatment, relapse, herpes zoster, randomized controlled trial, journal watch.
Synopsis edited by Dr Linda French, Toledo, Ohio. Posted on Global Family Doctor 02 February 2010

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.