A double-blind, placebo-controlled, randomized trial of cladribine in relapsing-remitting multiple sclerosis.
We conducted an 18-month, placebo-controlled, double-blind study to evaluate cladribine in the treatment of 52 patients with relapsing-remitting multiple sclerosis. Patients received either placebo or cladribine 0.07 mg/kg/day by subcutaneous injection for 5 consecutive days as six monthly courses for a total cumulative dose of 2.1 mg/kg. Analysis of results revealed a statistically significant favorable effect of cladribine on the joint frequency and severity of relapses and magnetic resonance imaging (MRI) findings. MRI-enhancing lesions were completely suppressed in the cladribine patients by the sixth month of treatment. Mild segmental herpes zoster occurred in two cladribine-treated patients and one patient receiving placebo. Otherwise, there were no side effects or adverse events. We conclude that cladribine shows promise as a treatment for relapsing-remitting multiple sclerosis.
Romine
J S
JS
Division of Neurology, Scripps Clinic, La Jolla, CA 92037, USA.
Sipe
J C
JC
Koziol
J A
JA
Zyroff
J
J
Beutler
E
E
D000279:Administration, Cutaneous; D000328:Adult; D017338:Cladribine / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D011859:Radiography; D012008:Recurrence; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D017338:Cladribine