New Version of Old MS Drug Performs Well in Clinical Trial
Scientists test long-acting peg-interferon
Tests of a new long-acting version of one of the oldest multiple sclerosis (MS) drugs on the market show it worked significantly better than placebo in reducing the number of patient relapses and the development of new or active lesions, researchers report. Most important, the updated version was effective even though injections were given every 2 weeks instead of every other day, and it appears that fewer patients developed resistance to it.
The industry-funded, international clinical trial, led by a Johns Hopkins scientist, found that long-acting pegylated interferon (peg-IFN) beta worked better than placebo for patients with the most common form of MS. The beneficial effects were comparable with what was found in previous studies in which the standard formulation of IFN beta (which must be taken more frequently) was compared with placebo.
In a report published May 1 in The Lancet Neurology, the researchers say they also found that while about 20% of MS patients typically develop antibodies against IFN beta that ultimately neutralize its effects, fewer than 1% in the new study did, suggesting far more patients could benefit from the new formulation.
The researchers recruited more than 1,500 subjects with MS in 26 countries. For 1 year, 500 patients received a placebo injection every 2 weeks; 500 patients received a 125-mcg injection of peg-IFN beta-1a every 2 weeks; and the remaining 500 patients received a 125-mcg injection of peg-IFN beta-1a once a month, with a placebo injection given at every other visit.
After 1 year, patients who had received peg-IFN beta-1a every 2 weeks experienced a 36% reduction in the yearly relapse rate compared with the placebo group; the once-a-month group saw a 28% reduction. Magnetic resonance imaging (MRI) scans showed 67% fewer new or active lesions in the 2-week group, whereas those injected every 4 weeks had 28% fewer lesions.
Both the 2- and 4-week groups had a 38% reduction in disability progression (on a scale that measured walking speed, vision, strength, and sensation) compared with the placebo group.
The new long-acting formulation of peg-IFN beta appeared to be as safe as the older one, although flu-like symptoms from the long-acting drug lasted closer to 24 hours after each injection in some patients.
Data presented April 29 at the American Academy of Neurology indicated that administering peg-IFN beta every 2 weeks is the best dosing schedule.
In 1993, IFN beta became the first drug approved by the FDA for the treatment of MS because of its ability to block certain types of immune-cell activation and the trafficking of immune cells into the brain.
Source: Johns Hopkins Medicine; May 1, 2014.