E. Beutler et al., THE TREATMENT OF CHRONIC PROGRESSIVE MULTIPLE-SCLEROSIS WITH CLADRIBINE, Proceedings of the National Academy of Sciences of the United Statesof America, 93(4), 1996, pp. 1716-1720
A 2-year, placebo-controlled, double-blind, crossover study was starte
d in 1992 to evaluate cladribine, an immunosuppressive drug, in the tr
eatment of chronic progressive multiple sclerosis, In the first year p
atients were given cladribine 0.10 mg/kg per day for 7 days as four mo
nthly courses for a total of 2.8 mg/kg or placebo, During the second y
ear patients treated with placebo during the first year were given i,v
, infusions of 0.10 mg, 0.05 mg, and 0.05 mg of cladribine per kg of b
ody weight per day for 7 consecutive days in three successive monthly
courses, for a total dose of 1.4 mg/kg, Patients who had been treated
previously with cladribine were crossed over to placebo, Analysis of t
he results revealed a favorable influence on the neurological performa
nce scores, both in the Kurtze extended disability status and the Scri
pps neurological rating scale, and on MRI findings in patients treated
with cladribine. In the first year the most striking finding was that
while clinical deterioration continued in the placebo treated patient
s, the condition of patients who received cladribine stabilized or eve
n improved slightly, Toxicity and therapeutic response were dose-relat
ed.