2 New Drugs May Fight Multiple Sclerosis
Study Shows Cladribine and Fingolimod Cut Relapse Rate in MS Patients
April 30, 2009 (Seattle) -- Two new oral drugs cut by about half the relapse rate in people with multiple sclerosis (MS).
If approved by the FDA, the drugs -- cladribine and fingolimod -- would become the first treatments for MS that don't involve regular injections or infusions.
In one study, about 80% of MS patients who took the chemotherapy drug cladribine were relapse-free for two years vs. 61% given placebo.
In a second study, 80% to 84% of MS patients taking the immune-suppressing drug fingolimod were relapse-free after one year of daily treatment, compared with 67% of those taking the standard injectable MS drug Avonex.
Either drug will meet a huge unmet need as "a lot of patients refuse to go on treatment right now because it involves injections," says Lily Jung, MD, medical director of the neurology clinic at the Swedish Neurology Institute in Seattle. Jung was not involved in either study.
Both studies were presented at the annual meeting of the American Academy of Neurology.
Cladribine Fights Multiple Sclerosis
Cladribine, already licensed for treating leukemia under the brand name Leustatin, suppresses the autoimmune responses thought to cause MS. In MS, T cells -- the "generals" of the immune system -- go haywire and order attacks on the myelin sheaths that surround and protect the brain cells.
"Cladribine damages the ability of the T cells to reproduce and proliferate," Jung says.
The new phase III study involved about 1,200 patients with the relapsing form of multiple sclerosis, characterized by repeated relapses with periods of recovery in between. They suffered from the disease for an average of six to seven years, and all had at least one relapse in the year before entering the study.
Patients were given either four courses of low-dose cladribine tablets or six courses of higher-dose cladribine tablets, or a placebo.
Each course consisted of one to two tablets per day for four or five days, "meaning that individuals with MS only have to take tablets for eight to 20 days a year," says Gavin Giovannoni, MD, of the Barts and London School of Medicine and Dentistry, which led the study.
That should improve compliance, he says.
The patients were followed up for nearly two years and monitored using MRI scans.