Long-Term Use of MS Drug Seems Safe

April 18, 2005 -- The multiple sclerosis drug Betaseron appears to be safe for long-term use, according to a study sponsored by Berlex Inc., the drug's maker.

Only the preliminary results are in. The full data are expected later this year.

The early findings focus on 234 MS patients who participated in a study of Betaseron 16 years ago. More of those who had taken 250 micrograms of Betaseron every other day in the study were still alive and walking without assistance, compared with those who had taken a placebo.

"In general, multiple sclerosis does not substantially reduce life expectancy but numerous studies have demonstrated a modest, yet clear, reduction in untreated patients," says George Ebers, research professor at Oxford University's clinical neurology department, in the news release.

The researchers presented their findings at the American Academy of Neurology's annual meeting.

Following Up After 16 Years

Multiple sclerosis is a chronic neurological disease of the central nervous system (specifically, the brain, spinal cord, and optic nerves). In relapsing-remitting multiple sclerosis, symptoms can fade and recur randomly over many years.

All participants had relapsing-remitting multiple sclerosis, the most common form of the disease.

The researchers tracked down 234 people who had participated in the original study (63% of the group). Most (89%) were still alive. As of April 2005, about 20 years had passed, on average, since participants had been diagnosed with multiple sclerosis.

When the original trial began in 1988-1990, participants were assigned to get injections every other day of 250 micrograms of Betaseron, 50 micrograms of Betaseron, or a placebo for two years.

Later, participants were allowed to stay with their assigned treatment for up to five years. When the 250-microgram dose of Betaseron was approved for use, everyone was allowed to take it. The study was conducted at 11 sites in the U.S. and Canada, all of which participated in the follow-up.

Sixteen years later, more people who started with 250 micrograms of Betaseron were alive and walking, say the researchers. That's based on the people they could locate after all those years.

Of the original 250-dose group, 73 out of 78 patients were still alive (94%). For the 50 microgram group, 72 out of 78 were still alive (92%). Among the placebo group, 64 out of 78 patients were still living (82%).

More People Walking With Betaseron

Of the 234 patients, 99 (42%) said they could walk by themselves or with aides. That included half of the 250-microgram dose group (39 people), 28 from the 50-microgram dose group, and 32 from the placebo group (41%).

Forty-three people (19%) said they relied on a wheelchair or were bedridden. That included 14 people from the 250-microgram dose group, 16 from the 50-microgram dose group, and 13 from the placebo group.

The results indicate that starting the 250 microgram dose early "has a long-lasting beneficial impact," say researchers. "To date, patients treated with 250 micrograms in the pivotal trial are more likely to report continued ability to walk than those patients receiving placebo."