Long-Term Use of MS Drug Seems Safe
Preliminary Results Are in for 16-Year Follow-Up of Betaseron Study
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."
"While it is premature to draw firm conclusions from preliminary data, I am particularly struck by the mortality trend among patients in the placebo arm appearing to be threefold different than that of patients receiving Betaseron," says researcher Barry Arnason, MD, in a news release.
"The reasons for this difference are unknown right now, but hopefully, we will get a clearer understanding of why this difference occurred when the study is completed and the data analyzed more thoroughly," continues Arnason, who works at the University of Chicago's neurology department.
The full report will include data on functions such as memory, attention, and reasoning, says Ebers.
The follow-up data didn't include side effects. According to Berlex, possible side effects include decrease in infection-fighting white blood cells, injection site reaction, weakness, flu-like symptoms, headache, and pain.
Caution should be used with depressed patients, says Berlex. Also, the drug company recommends rotating the injection sites, noting that injection site necrosis has been reported in 5% of patients in trials.
Women should be warned about potential risks of using the drug while pregnant, and cases of a rare but potentially life-threatening allergic reaction have also been reported, says Berlex.