Long-Term Use of MS Drug Seems Safe
Preliminary Results Are in for 16-Year Follow-Up of Betaseron Study
April 18, 2005 -- The drug 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
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
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."